linjc16/ctgov huggingface dataset:
Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.

Official Title
-----------------
Enquête épidémiologique Sur la prévalence et le Pronostic de l'Histiocytose Langerhansienne Pulmonaire de l'Adulte en France

Conditions
-----------------
Histiocytosis, Histiocytosis, Langerhans-Cell, Histiocytosis Pulmonary

Intervention / Treatment
-----------------
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Diagnosis of PLCH was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following criteria: 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (HRCT) and 3) exclusion of alternative diagnoses Exclusion Criteria: -

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 |
| --- | --- |
| Pulmonary Langerhans cell histiocytosis (PLCH)<br>All patients with newly diagnosed PLCH at adulthood (i.e. 18 years of age or older) referred to the French national reference centre for Histiocytoses | Other: Standard of care<br>* Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival defined as the time from inclusion to death from any cause. | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRF | Cumulative incidence of chronic respiratory failure (CRF) from inclusion | 20 years | 
| PH | Cumulative incidence of pulmonary hypertension (PH) from inclusion | 20 years | 
| Malignant diseases | Cumulative incidence of Malignant diseases from inclusion | 20 years | 
| Extra-pulmonary involvement in isolated PLCH | Cumulative incidence of extra pulmonary localisations from inclusion | 20 years | 
| Annual prevalence | Number of people with the disease at any time during a year | 20 years |
Proton MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the feasibility of in vivo single volume MR spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T MR instrument. In order to optimize and avoid ineffective treatment of patients with brain metastases, in vivo MR spectroscopy can be an useful tool.

Official Title
-----------------
Single Volume 1H MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.

Conditions
-----------------
Neoplasm Metastasis, Lung Neoplasms, Breast Neoplasms, Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of brain metastases Exclusion Criteria: children 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?
-----------------
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
-----------------
Lipid, choline, metastasis, magnetic resonance spectroscopy, treatment response
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Study Overview
=================
Brief Summary
-----------------
Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity. The investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.

Official Title
-----------------
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Conditions
-----------------
Bronchial Fistula

Intervention / Treatment
-----------------
* Biological: hAEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with bronchial fistula by Imaging or bronchoscopic examination typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss… patients present compromised conditions, who can only accept a conservative treatment. Exclusion Criteria: absolute contraindication of bronchoscopic examination and treatment with previous treatment of cell therapy, including stem cells.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hAEC treatment<br>hAEC: human amniotic epithelial cells 3-5*10^7 /5 ml | Biological: hAEC<br>* hAEC: human amniotic epithelial cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median time for fistula closure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | fever, coughing up blood, infection... | 1 year |
Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.

Official Title
-----------------
A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes

Conditions
-----------------
Prediabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Low dose of blueberry dry powder
* Dietary Supplement: High dose of blueberry dry powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting plasma glucose 110-125 mg/dL Exclusion Criteria: Taking anti-diabetic drugs Taking drugs or functional food that may affect blood glucose level Fruit allergy Pregnant or nursing a child Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose of blueberry dry powder<br>0.5 g blueberry dry powder, twice a day for 12 weeks | Dietary Supplement: Low dose of blueberry dry powder<br> <br> |
| Experimental: High dose of blueberry dry powder<br>5.0 g blueberry dry powder, twice a day for 12 weeks | Dietary Supplement: High dose of blueberry dry powder<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose from baseline |  | Every 6 weeks (Overall 12 weeks) | 
| Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline |  | Weeks 0 and 12 | 
| Change in HbA1c from baseline |  | Weeks 0 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycoalbumin from baseline |  | Every 6 weeks (Overall 12 weeks) | 
| Change in fasting insulin from baseline |  | Weeks 0 and 12 | 
| Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline | HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405 | Weeks 0 and 12 | 
| Change in serum C-peptide from baseline |  | Weeks 0 and 12 |
Nutrition in Pregnancy, Birth Weight, and Childhood Asthma

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of maternal diet and birth weight in the etiology of childhood asthma and other allergic disorders.

Detailed Description
-----------------
BACKGROUND: Asthma is one of the most common chronic diseases diagnosed among children in the developed world, and its prevalence in western industrialized countries is increasing at an alarming rate. Little information is currently available regarding the role of maternal diet during pregnancy and birth weight in the risk of childhood asthma. DESIGN NARRATIVE: This longitudinal prospective study takes advantage of the resources provided by Project Viva, an ongoing prospective cohort study of pregnant women and their infant offspring among members of Harvard Pilgrim Health Care, a large managed care organization in New England. Data already available from Project Viva include detailed dietary data on mother and infant, along with data on anthropometric, social, environmental, demographic, economic, psychological, and lifestyle variables. The study will follow the Project Viva cohort until ages 3 to 4 years.

Conditions
-----------------
Lung Diseases, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH

Study Overview
=================
Brief Summary
-----------------
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

Official Title
-----------------
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Conditions
-----------------
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Tamsulosin 0.2mg + Solifenacin 5mg
* Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 45 years Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form Exclusion Criteria: Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years Subjects who have acute urinary retention within 12 weeks before screening Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening Subjects who have hypersensitivity to investigational product Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum Subjects who have myasthenia gravis, narrow angle glaucoma Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption SBP > 180 mmHg or DBP > 100 mmHg HbA1c > 9.0 % Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.

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

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

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: Group I<br>Tamsulosin 0.2mg + Solifenacin 5mg | Drug: Tamsulosin 0.2mg + Solifenacin 5mg<br>* Tamsulosin 0.2mg + Solifenacin 5mg for 12wks<br>|
| Placebo Comparator: Group II<br>Tamsulosin 0.2mg + Placebo(Solifenacin) | Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)<br>* Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of TUFS |  | 12 weeks from baseline | 
| change of total IPSS |  | 12 weeks from baseline |
Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.

Official Title
-----------------
A Single-center, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Aprocitentan
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening Exclusion Criteria: - Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT-132577<br>3 different dose levels | Drug: Aprocitentan<br>* Formulated in capsules in 2 different strengths; 2 capsules per day<br>* Other names: ACT-132577;|
| Placebo Comparator: Placebo<br>Matching active drug | Other: Placebo<br>* Matching active drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Change from baseline | from Day 1 to Day 9 |
Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

Study Overview
=================
Brief Summary
-----------------
To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

Detailed Description
-----------------
Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.

Official Title
-----------------
Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity

Conditions
-----------------
Infant, Premature, Diseases

Intervention / Treatment
-----------------
* Drug: intravitreal ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with vascularly active ROP intravitreal ranibizumab Exclusion Criteria: already accepted laser therapy

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 3 Months

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: serum VEGF level<br>Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab | Drug: intravitreal ranibizumab<br>* 0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)<br>* Other names: lucentis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of intravitreal ranibizumab on serum VEGF level | the changes of the serum VEGF levels | 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of intravitreal ranibizumab on weight | measure weight of the infants | corrected age of six month | 
| The effect of intravitreal ranibizumab on height | measure height of the infants | corrected age of six month | 
| The effect of intravitreal ranibizumab on neurologic development | Gesell development diagnosis scale | corrected age of six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinopathy of prematurity, ranibizumab, vascular endothelial growth factor
Post-Ibrutinib Colitis and Intestinal Microbiota

Study Overview
=================
Brief Summary
-----------------
Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology

Official Title
-----------------
Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.

Conditions
-----------------
Gastrointestinal Microbiome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years Outside the context of guardianship, -affiliated to the Social Security Regime and Having consented to participate in the COLMI study. Patient who benefit of treatment by targeted therapy to Ibrutinib Exclusion Criteria: History of uncontrolled colitis before the start of treatment. Patient with inflammatory bowel disease. Patient not consenting to participate.

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 |
| --- | --- | --- |
| difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis | With the different species and metabolites between the 2 groups of patients (patients developing diarrhea after exposure to Ibrutinib and those not developing diarrhea), we will create a risk score for occurrence of diarrhea during treatment with Ibrutinib, on the previously developed model (Montassier et al, 2016, Genome medicine) | At the end of the study, after 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify biomarkers of the gut microbiota associated with the occurrence of severe diarrhea (grade 3 and 4 CTCAE, version 4.0) in patients treated with Ibrutinib for malignant hemopathy B. |  | At the end of the study, after 2 years. | 
| Identify biomarkers of gut microbiota associated with the occurrence of diarrhea by subgroup: patients treated with Ibrutinib alone, patients treated with Ibrutinib in combination with another molecule |  | At the end of the study, after 2 years. | 
| Creation of a predictive score of the occurrence of diarrhea in patients treated with Ibrutinib for malignant hemopathy B, including the biomarkers of the intestinal microbiome and the clinical characteristics of the patient |  | At the end of the study, after 2 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut Microbiome, hematologic malignancies B, biomarkers, targeted therapy, Gut microbiota
Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.

Official Title
-----------------
NovoMix® 30 FlexPen, Post Marketing Surveillance Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diabetes who did not have indications that are contraindicated in the product insert
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* The insulin dose and regimen were individualised at the physician's discretion. Insulin was administered by subcutaneous injection using an injection device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose (FPG) |  |  | 
| Change in HbA1c (glycosylated haemoglobin) |  |  | 
| Occurrence of adverse events (non-serious and serious) |  |  |