linjc16/ctgov huggingface dataset:
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Detailed Description
-----------------
Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Official Title
-----------------
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Giving DHA-rich supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Delta F 508 homozygote Stable clinical situation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DHA-rich supplement<br> | Drug: Giving DHA-rich supplement<br>* Giving DHA-rich supplement to patients.<br>|
| Placebo Comparator: Placebo<br> | Drug: Giving DHA-rich supplement<br>* Giving DHA-rich supplement to patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study |  | before the study start and during the 2 years of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the fatty acid profile |  | during the 2 years of the study | 
| Oxidative stress status |  | during the 2 years of the study |
Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients

Study Overview
=================
Brief Summary
-----------------
The incidence of thrombocytopenia in ICU patients with severe illness ranged from 8.3% to 67.6%, and ranged from 14% to 44% during ICU treatment.Severe patients with thrombocytopenia also have significantly increased bleeding events and blood transfusions, and even a significantly increased risk of death.This study examines whether elevated platelets benefit patients with pneumonia

Official Title
-----------------
Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients With Pneumonia With Thrombocytopenia: a Multicenter, Single-blind, Randomized Controlled Study

Conditions
-----------------
Pneumonia, Thrombocytopenia

Intervention / Treatment
-----------------
* Drug: recombinant human thrombopoietin
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pneumonia (community acquired pneumonia, hospital acquired pneumonia or ventilator associated pneumonia); Voluntarily signed informed consent; ≥18 years old; Platelet count ≤75×109/L Exclusion Criteria: A history of hematopoietic stem cell transplantation or solid organ transplantation such as liver, kidney or lung; Hematological malignancy; Immune thrombocytopenia, such as SLE, ITP, TTP, etc. The length of stay in ICU is less than 24h; Pregnant or lactation patients;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the TPO group<br>Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days. | Drug: recombinant human thrombopoietin<br>* The dose of rhTPO is 15,000 U per day. The subcutaneous injection will be terminated when PCs are increased to normal. The duration of rhTPO will be 7 days.<br>|
| Placebo Comparator: the control group<br>Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days. | Drug: normal saline<br>* Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously. The duration of saline will be 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to recovery to a normal platelet level | The clinical recovery time of platelets was defined as the time it takes to reach clinical recovery. | 14 days |
Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide

Study Overview
=================
Brief Summary
-----------------
Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form. Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs from the sulfonylurea drug family, to whom Glibenclamide is included. The investigators assumption is that patients with less active alleles of the enzyme may show lower dose requirements of the drug for glycemic control, when compared to patients homozygotes to wild-type alleles.

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tx with metformin and glibenclamide Exclusion Criteria: Tx which affecting the P450 2C9 action Renal failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Extensive metabolizers<br> | |
| Intermediate mtabolizers<br> | |
| Poor metabolizers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 2 years |
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)

Study Overview
=================
Brief Summary
-----------------
This study will assess the effect of LCQ when added to metformin.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: LCQ908A
* Drug: LCQ908A
* Drug: LCQ908A
* Drug: LCQ908A
* Drug: LCQ908A
* Drug: Placebo
* Drug: Sitagliptin
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c from 7.0-10.0%, Stable Metformin dose Exclusion Criteria: CHF Class III-IV, Liver disease Other protocol-defined inclusion/exclusion criteria may apply

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCQ908 Dose 1<br> | Drug: LCQ908A<br> <br> Drug: metformin<br> <br> |
| Experimental: LCQ908 Dose 2<br> | Drug: LCQ908A<br> <br> Drug: metformin<br> <br> |
| Experimental: LCQ908 Dose 3<br> | Drug: LCQ908A<br> <br> Drug: metformin<br> <br> |
| Experimental: LCQ908 Dose 4<br> | Drug: LCQ908A<br> <br> Drug: metformin<br> <br> |
| Experimental: LCQ908 Dose 5<br> | Drug: LCQ908A<br> <br> Drug: metformin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> Drug: metformin<br> <br> |
| Active Comparator: Sitagliptin<br> | Drug: Sitagliptin<br> <br> Drug: metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of LCQ on measures of glucose control |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight and related measures |  | 12 weeks | 
| Insulin sensitivity |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

Official Title
-----------------
A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: GSK159797 (10, 15, and 20mcg)
* Drug: salbutamol
* Drug: salmeterol 50mcg
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid Female subjects only using acceptable birth control method Non-smokers FEV1 between 60 and 90% predicted Increase in FEV1 12% or greater and 300mL and greater after salbutamol use Exclusion criteria: Past or present disease conditions Normal screening Holter ECG Respiratory tract infection within 4 weeks of screening History of life threatening asthma Previous use of COA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK159797 (10, 15, and 20mcg)<br>GSK159797 (10, 15, and 20mcg) | Drug: GSK159797 (10, 15, and 20mcg)<br>* GSK159797 (10, 15, and 20mcg)<br>|
| Experimental: salbutamol<br>salbutamol | Drug: salbutamol<br>* salbutamol<br>|
| Experimental: salmeterol 50mcg<br>salmeterol 50mcg | Drug: salmeterol 50mcg<br>* salmeterol 50mcg<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>* Other names: salmeterol 50mcg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in trough FEV1 |  | after 14 day repeat doses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in trough FEV1 |  | after a single dose | 
| Mean change from baseline in trough FEV1 |  | after 7 days repeat dosing | 
| Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours |  | Day 1 and Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Efficacy, Asthmatic patients, GSK159797
Evaluation of Liquid vs. Tablet Buprenorphine - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.

Official Title
-----------------
Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective and observer rater physiological effects of bup |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependence
Intravesical Chemotherapy Treatment of Superficial Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.

Official Title
-----------------
Intravesical Gemcitabine Therapy in Intermediate Risk Superficial Bladder Cancer: A Phase II Study With the Marker Lesion

Conditions
-----------------
Bladder Neoplasms

Intervention / Treatment
-----------------
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Superficial bladder cancer No prior chemotherapy Exclusion Criteria: Grade 3 tumors Papillary tumors invading connective tissue Significant urologic disease, possible interfering with intravesical therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the relapse free survival |  |  | 
| To assess toxicity profile |  |  |
A Prospective Clinical Study of a Cohort of Patients Seeking Treatment for a Behavioral Addiction

Study Overview
=================
Brief Summary
-----------------
This research aims to provide a better understanding of the factors associated with the evolution of behavioral addictions, and compliance with care. The investigators thus aim to follow patients with several types of behavioral addictions, based on addictive, sociodemographic, clinical and endophenotypical characteristics, as well as their care adhesion.

Official Title
-----------------
A Prospective Clinical Study of a Cohort of Pathological Patients Seeking Treatment for a Behavioral Addiction in the University Hospital of Nantes

Conditions
-----------------
Behavioral Addictions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : - All consecutive patients seeking treatment at the University Hospital of Nantes for a behavioral addiction and age over 15 will be allowed to participate to the study. Exclusion Criteria : Cognitive impairment incompatible with the assessment Difficulty for writing or reading the French language, incompatible with the assessement Gardianship

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of behavioral addictions | Understand what determines the evolution of behavioral addictions and compliance with care. Study the outcome of patients with behavioral addictions, both in terms of the evolution of of the addictive pathology and associated clinical and endophenotypic characteristics, as well as adherence to care. | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cohort, cognitive distortions, impulsivity, psychiatric comorbidities, addiction, gambling disorder, sexual addiction, videogame disorder, food addiction, eating disorders, compulsive buying, behavioral addictions
SNUH MICU Cohort Study of PICS

Study Overview
=================
Brief Summary
-----------------
Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge

Official Title
-----------------
Cohort Study of Patients Patients in the Medical Intensive Care Unit to Evaluate Postintensive Care Sydnrome

Conditions
-----------------
Critical Care, Registries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the medical intensive care unit Exclusion Criteria: Patients admitted to the intensive care unit for simple procedures Patients admitted for postoperative care observation

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Functional status | Clinical frailty scale, The de Morton Mobility Index | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival | 1 year |
What do built-in Softwares in Home Ventilators Tell us?

Study Overview
=================
Brief Summary
-----------------
Home bi-level positive pressure ventilators are equipped with built-in softwares which measure and record specific items such as tidal volume, total ventilation, leaks, respiratory rate, cycles triggered by the patient. These items have not to date been described in a large group of patients under home mechanical ventilation.

Detailed Description
-----------------
Observational study of patients under home positive pressure mechanical ventilation, in a stable condition. Data recorded by ventilator software is downloaded by specialized nurses during elective home visits, as well as spirometry, results of recent pulse oximetry, ventilator settings, diagnosis, and basic anthropometric data. Items recorded by ventilator software are: tidal volume, total ventilation, apnea and hypopnea index, leaks, percentage of inspiratory cycles triggered by ventilator, spontaneous and back-up respiratory rates. Results are reported by diagnostic group. Statistical analysis (univariate and multivariate) aims to determine which variables are related to unintentional leaks, and whether ventilator settings differ significantly between diagnostic groups.

Official Title
-----------------
What do built-in Softwares in Home Ventilators Tell us? An Observational Study of 150 Patients on Home Ventilation

Conditions
-----------------
Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients with home noninvasive ventilation with bi-level positive pressure home ventilators with integrated software Exclusion Criteria: Hospitalisation or acute exacerbation; Ventilation with a device not equipped with built-in software, Ventilation with servo-assisted ventilator Invasive ventilation (tracheostomy)

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 |
| --- | --- | --- |
| Analysis of data downloaded from ventilator software by diagnostic category | Analysis of data provided by ventilator software during elective home visits by specialized nurses in stable patients under home ventilation. Data includes all ventilator parameters, leaks, tidal volume, total ventilation, respiratory rate, % of cycles triggered by the patient, apnea-hypopnea index, and compliance. Age, gender, BMI, spirometry, type of mask and pulse oximetry are also available. The analysis will describe ventilatory patterns and ventilator settings as a function of diagnosis, as well as factors related to importance of leaks (age, interface, ventilator settings). | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noninvasive ventilation, ventilator software, ventilator settings, domiciliary ventilation
Early Diagnostic Biomarkers of Sepsis

Study Overview
=================
Brief Summary
-----------------
A Comparison between CRP, ferritin, and serum zinc as early diagnostic biomarkers of sepsis in critically ill patients

Official Title
-----------------
A Comparison Between CRP, Ferritin and Serum Zinc as Early Diagnostic Biomarkers of Sepsis in Critically Ill Patients

Conditions
-----------------
Critically Ill, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with chest infection and UTI. Exclusion Criteria: children

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Study of some biomarkers as indicators of sepsis. | Measurement of CRP as early diagnostic biomarker of sepsis | about 2 years | 
| Study of some biomarkers as indicators of sepsis. | Measurement of ferritin as early diagnostic biomarker of sepsis | about 2 years | 
| Study of some biomarkers as indicators of sepsis. | Measurement of serum Zinc as early diagnostic biomarker of sepsis | about 2 years |