linjc16/ctgov huggingface dataset:
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

Study Overview
=================
Brief Summary
-----------------
The main objectives of the study are: 1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists) The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses: Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist. These subgroups have different responses to anti-leukotrienes.

Official Title
-----------------
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

Conditions
-----------------
Asthmatic Patients

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: long acting beta2 mimetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA) Exclusion Criteria: viral/fungal/bacterial infection +fever (<1 month) asthma exacerbation (<3 months) other respiratory disease (CF, ciliary dyskinesia,bronchiectasis) cardiac patients using beta-blockers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br> | Drug: Montelukast<br>* Montelukast, 10 mg<br>|
| Active Comparator: long-acting beta2-mimetic<br> | Drug: long acting beta2 mimetic<br>* ICS+long acting beta2 agonist: twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum cytokine mRNA |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responsiveness to the medication |  | 8 weeks |
Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.

Official Title
-----------------
Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: insulin human
* Drug: insulin lispro
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with Type 1 diabetes for at least one year HbA1c less than 12% Willing to administer at least 3 injections per day Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin human|nan|
|Drug: insulin lispro|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin A1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG (fasting plasma glucose) |  |  |
Metalloproteinases and Recurrent Corneal Erosion Syndrome

Study Overview
=================
Brief Summary
-----------------
Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy of the basement membrane or following corneal trauma. This syndrome is characterized by recurrent episodes of ocular pain more or less associated with localized separations between the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage abnormalities between these two corneal layers. This could be the result of an increased expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the basement membrane. The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3 in the RCE syndrome.

Conditions
-----------------
Recurrent Corneal Erosion Syndrome

Intervention / Treatment
-----------------
* Other: in vitro immuno-histo-chemical analysis of corneal epithelium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Recurrent Corneal Erosion Syndrome, with - failure of medical treatment and therapeutic photokeratectomy scheduled Photorefractive surgical keratectomy (control patients) Exclusion Criteria: Opposition to participation in the study Known pregnancy or breast-feeding patient No medical insurance coverage

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 |
| --- | --- |
| recurrent corneal erosion<br> | Other: in vitro immuno-histo-chemical analysis of corneal epithelium<br> <br> |
| control patients (refractive surgery)<br> | Other: in vitro immuno-histo-chemical analysis of corneal epithelium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells |  | baseline |
Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM & PM).

Detailed Description
-----------------
Molkosan® is made from fresh organic whey using a special fermentation process involving lactic acid producing bacteria (L+ lactic acid 70g/L). The company, A.Vogel (Roggwil, Switzerland) will provide the product and we will collect biological samples for analysis in a proof of concept study design that will provide preliminary data for future larger studies.

Official Title
-----------------
The Use of Fermented Whey Concentrate in Healthy Adults

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

Intervention / Treatment
-----------------
* Dietary Supplement: Molkosan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 BMI 18-40 kg/m-2 Exclusion Criteria: Diabetes Severe gastrointestinal disorders, Kidney disease, Thromboembolic or coagulation disease, Hepatic disease, Alcohol or any other substance abuse Gout Eating disorders Unregulated thyroid disease Dairy intolerance Antibiotic use within the last 3 months, including prescribed use Current prebiotic or prebiotic use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molkosan<br>Consumption of Molkosan (fermented whey) 20ml to be diluted in 200ml water prior to use twice a day (morning & evening). Total duration was 6 weeks. | Dietary Supplement: Molkosan<br>* Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiota activity | Faecal short-chain fatty acids, measured by gas chromatography | Baseline, day 21 and 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose tolerance (Oral glucose tolerance test (OGTT) | Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level and insulin are analysed as total area under the curve (AUC) and incremental AUC. | Baseline, day 21 and 42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food supplement, Fermented food, Whey
Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether increasing cardiac output by a combination of intravenous fluids and inotropic drugs can reduce mortality and morbidity in radical cystectomy operations.

Official Title
-----------------
Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy

Conditions
-----------------
Radical Cystectomy, Perioperative Complications, Hemodynamic Monitoring

Intervention / Treatment
-----------------
* Other: Increasing oxygen delivery .


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (>18yo) scheduled for elective radical cystectomy and ileal conduit formation Exclusion Criteria: Creatinine level above 200 mcg/dl single functioning kidney s/p kidney transplant heart rhythm other than sinus known allergy to lithium chloride chronic lithium therapy weight below 40 kg mental or language problems that precludes obtaining informed consent

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidco group<br>All patients monitored by the lidco system and treated to optimize oxygen delivery | Other: Increasing oxygen delivery .<br>* The target is increasing oxygen delivery above 600ml/min/mr2 by either bolus of iv colloid or a continuous infusion of dopamine, dobutamine or noradrenaline. The fluids and drug administration will be directed and monitored by the lidco system and transesophageal echocardiography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | Hospital stay |
Study of Hemodynamic Conditions Measured During Hepatectomy

Study Overview
=================
Brief Summary
-----------------
Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation. The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients. It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function. The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.

Detailed Description
-----------------
Measurements of flow rates in the portal vein and the hepatic artery by different transit times are available thanks to the Medistim VeriQTM system that the investigators already use routinely in the context of liver transplantation when performing hepatectomies.

Official Title
-----------------
Study of Hemodynamic Conditions Measured During Hepatectomy

Conditions
-----------------
Liver Dysfunction, Circulatory; Change

Intervention / Treatment
-----------------
* Procedure: Liver debit measure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient 18 years or more Patient undergoing laparotomy for liver resection Exclusion Criteria: Patient under tutorship or curatorship Pregnant or lactating woman Difficulties in understanding French Patient operated by laparoscopy Patient having objected to the processing of his data

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 |
| --- | --- |
| Hepatectomy<br>Patient undergoing laparotomy for liver resection. The aim is to measure the flow rates in the portal vein and the hepatic artery. | Procedure: Liver debit measure<br>* Mesure of liver debit during hepatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver vessel debit | Mesure of liver debit during hepatectomy | Baseline |
Flax Mucilage and Apparent Nutrient Digestibility

Study Overview
=================
Brief Summary
-----------------
The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.

Detailed Description
-----------------
A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.

Official Title
-----------------
Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: fiber drink and fiber bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40y BMI 22-28 healthy Exclusion Criteria: smoking medication excess PA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fiber drink<br> | Dietary Supplement: fiber drink and fiber bread<br>* fiber drink or fiber bread three times daily<br>|
| Experimental: fiber bread<br> | Dietary Supplement: fiber drink and fiber bread<br>* fiber drink or fiber bread three times daily<br>|
| Experimental: placebo<br> | Dietary Supplement: fiber drink and fiber bread<br>* fiber drink or fiber bread three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat and energy digestibility |  | mean over period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appetite |  | three times daily | 
| gastrointestinal distress |  | continously | 
| lipid profile |  | end of each period | 
| glucose and insulin |  | end of each period | 
| fecal output and transit time |  | mean of each period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary fiber, obesity, apparent energy digestibility
Bakircay University Cigli Training and Research Hospital

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer

Detailed Description
-----------------
Patient divided into two group.First group includes patients underwent TUR-BT under only spinal anesthesia and second group includes patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade.

Official Title
-----------------
Bakircay University Cigli Training and Research Hospital

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: Obturator nerve blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with lateral wall localized non muscle invasive bladder cancer Exclusion Criteria: history of previous TUR-BT diagnosis of non-urothelial carcinoma coagulopathy history of allergic reaction to the local anesthtetic agent presence of muscle-invasive bladder cancer history of chemotherapy or radiotherapy before TUR-BT precence of variant histopathology using bipolar energy for the resection of bladder tumor presence of concomittant upper urothelial tract urothelial carcinoma patients with the neuromusculer disease pregnancy history of medication effecting immune system
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>Patients underwent TUR-BT under spinal anesthesia | Procedure: Obturator nerve blockade<br>* We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer<br>|
| Study group<br>Patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade | Procedure: Obturator nerve blockade<br>* We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological outcomes | Reccurens or progression of tumor was recorded | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications during surgery was recorded | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obturator nerve blockade, bladder cancer, non-muscle invasive bladder cancer, adductor contraction, bladder perforation
A Phase II Study of Apatinib in STS Patients

Study Overview
=================
Brief Summary
-----------------
Apatinib is a kind of innovative medicines approved by China Food and Drug Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.

Official Title
-----------------
Effectiveness and Safety of Apatinib for the Patients With Advanced Soft Tissue Sarcoma

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Drug: apatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma. Must have evidence of unresectable residual disease. In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment. ECOG ps≤2. Life expectancy: more than 3 months. Prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway. Not pregnant or nursing；Fertile patients must use effective contraception. Hematopoietic HB≥90g/L Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 80,000/mm^3 Exclusion Criteria: Uncontrollable hypertension; Has influence of oral drugs; Patients with high risk of gastrointestinal blooding; INR>1.5×ULN，APTT>1.5×ULN; Allergic to any ingredient of this product; Less than 1 month since last major surgery; Brain metastases; With the second cancer.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apatinib group<br>apatinib 500mg po qd | Drug: apatinib<br>* apatinib 500mg po. qd.<br>* Other names: apatinib mesylate tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months PFS rate | Analyse PFS rate at 6 months | From baseline to 6 months |