linjc16/ctgov huggingface dataset:
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Licarbazepine 750 ¿ 2000 mg/d as Adjunctive Therapy to an Atypical Antipsychotic in the Treatment of Manic Episodes of Bipolar I Disorder Over 6 Weeks

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Licarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling) In need of psychiatric treatment Cooperation and willingness to complete all aspects of the study Exclusion Criteria: Current diagnosis other than bipolar I disorder History of schizophrenia or schizoaffective disorder Drug dependence within 1 month prior to study start or testing positive in a urine drug test Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others Any form of psychotherapy within 1 month prior to study start

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, manic episode, treatment, licarbazepine
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).

Official Title
-----------------
Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device in Patients With Atrial Septum Defect (ASD) and Patent Foramen Ovale (PFO)

Conditions
-----------------
Atrial Septal Defect, Patent Foramen Ovale

Intervention / Treatment
-----------------
* Device: Solysafe Septal Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASD PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO Exclusion Criteria: Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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 |
| --- |
|Device: Solysafe Septal Occluder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics of Procaterol in Elite Athletes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.

Detailed Description
-----------------
Doping study

Official Title
-----------------
Procaterol in Elite Athletes - a PK Study

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doctor diagnosed asthma for the asthmatic group GINA 1-3 for the asthmatic group Use of beta2-agonist for at least 12 months for the asthmatic group age 18-45 males informed consent Exclusion Criteria: smoker or former smoker airway infection to weeks prior to the study or during the study other chronic diseaes than asthma and allergy Use of beta2-agonist 6 days prior to the study Allergy to the study medicine

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma<br>With positive asthma test | |
| Healthy<br>With no signs of asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine concentration of drug 0-24 h | In healthy subjects to investigate drug farmakokenetic | 7 days | 
| serum concentration of drug 0-24 h | In healthy subjects to investigate drug farmakokenetic | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elite athletes
Prevention of Liver Damage During Liver Surgery

Study Overview
=================
Brief Summary
-----------------
Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.

Official Title
-----------------
Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections

Conditions
-----------------
Liver Tumors

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: adenosine
* Drug: adenosine
* Procedure: Liver resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective resection of liver tumors age 18 to 80 years informed consent Exclusion Criteria: chronic obstructive pulmonary disease heart insufficiency NYHA III-IV atrio-ventricular conductance blockage II. (Mobitz) or III. degree atrial fibrillation coronary heart disease (CCS III. or IV. degree) arterial hypertension acute renal failure increased intracranial pressure gout pregnancy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>liver resection with Pringle + placebo | Drug: placebo<br>* NaCl 0,9 %<br>Procedure: Liver resection<br>* Liver resection with Pringle maneuver<br>|
| Active Comparator: 2<br>liver resection with Pringle + adenosine preconditiong | Drug: adenosine<br>* intravenous infusion of adenosine 0, 2 %<br>Procedure: Liver resection<br>* Liver resection with Pringle maneuver<br>|
| Active Comparator: 3<br>liver resection with Pringle + adenosine pre- and postconditioning | Drug: adenosine<br>* intravenous infusion of adenosine 0,2 %<br>Procedure: Liver resection<br>* Liver resection with Pringle maneuver<br>|

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
-----------------
liver surgery
To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed

Study Overview
=================
Brief Summary
-----------------
Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours GROUP B : 110 Patients will receive standard care only NAC will be given at following rate : Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs

Official Title
-----------------
TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED

Conditions
-----------------
Ischemic Hepatitis

Intervention / Treatment
-----------------
* Drug: Standard Care + NAC (N -ACETYLCYSTEINE)
* Drug: Standard Care (in control arm)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 and < 75 Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours. Exclusion Criteria: Non cirrhotic Hepatocellular carcinoma Advanced cardiopulmonary disease Pregnancy Extrahepatic malignancy Patient on anticoagulation therapy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Care + NAC (N-ACETYLCYSTEINE) infusion<br> | Drug: Standard Care + NAC (N -ACETYLCYSTEINE)<br> <br> Drug: Standard Care (in control arm)<br> <br> |
| Active Comparator: Standard Care<br> | Drug: Standard Care (in control arm)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed. |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed. |  | 6 weeks | 
| To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis). |  | day 5 |
Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline NLR is correlated with overall survival after curative treatment for BC and 2) that baseline NLR is correlated with the survival benefit of NAC. The study will look at the data from participants of the SWOG 8710 study.

Official Title
-----------------
Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SWOG 8710 original trial inclusion criteria included: Node-negative, muscle-invasive transitional cell carcinoma of the bladder, T2-T4aN0M0 per the AJCC 4th edition staging manual. SWOG performance status of 0 or 1 Adequate organ function by lab criteria (WBC > 4,000 cells/mm3, platelets >150,000 cells/mm3, creatinine <1.5 md/dL (men) or <1.3 md/dL (women), baseline liver tests < 2 times normal limits) Inclusion criteria for this secondary analysis are: Eligible for original SWOG 8710 trial Had complete blood count with differential prior to first treatment (radical cystectomy or NAC). Exclusion Criteria: SWOG 8710 original trial exclusion criteria included: No age restrictions Previous or concomitant malignancy other than bladder cancer or basal cell skin cancer Prior pelvic radiation Metastatic or incurable disease Laboratory values exceeding those detailed in 3.1.c Exclusion criteria for this secondary analysis are: Ineligibility for the original SWOG 8710 study Lack of complete blood count with differential prior to first treatment (cystectomy or NAC).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Prognostic<br>Patients with NLR who completed curative therapy (surgery with or without chemo) | |
| Predictive<br>Patients with NLR who were assigned to a trial arm (chemo or no chemo) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Number of participants who survived at 26 years are reported. | 26 years |
Correlation Between Respiratory Impairment and Phonemes Alteration in Dystrophinopathy Patients With Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Communication is essential for patients quality of life because it impact on patients care quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal communication of the patient. Therefore, speech must to be functional. However, correlation between respiratory failure and voice quality is not very well known. The aim of the study is to search a link between respiratory failure and speech impairment in patients with neuromuscular diseases.

Conditions
-----------------
During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests

Intervention / Treatment
-----------------
* Behavioral: phonetic tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Respiratory autonomy at least 1 hour per day Stable patient during the study Patient with education at least up to secondary school Exclusion Criteria: Refusal to participate Inability to cooperate Tracheostomized patients Mechanic ventilation - dependant patients Respiratory autonomy lower than 1 hour per day Patients with hemodynamic instabillity Patient insured under the French social security system

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 |
| --- |
|Behavioral: phonetic tests|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intelligibility phonetic test |  | 5 minutes | 
| Number and nature of altered phonemes |  | 5 minutes |
A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

Study Overview
=================
Brief Summary
-----------------
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.

Official Title
-----------------
A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: PF-03893787
* Drug: Placebo
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 18-60 years. Mild asthma Atopic to allergens Exclusion Criteria: Unstable asthma. Smokers or recent ex-smokers Recent allergen challenge

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03893787<br> | Drug: PF-03893787<br>* Oral, two doses 12 hours apart<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral, two doses 12 hours apart<br>|
| Active Comparator: Montelukast<br> | Drug: Montelukast<br>* Oral, two doses 12 hours apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry pre- and post- bronchial allergen challenge |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory safety tests |  | 2 months | 
| 12-lead ECGs |  | 2 months | 
| Adverse Event reporting |  | 2 months | 
| Blood samples for pharmacokinetic measurement |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma Allergen Challenge
Rheumatoid Arthritis Response to Methotrexate

Study Overview
=================
Brief Summary
-----------------
Observational and prospective study of the ultrasound response to methotrexate in rheumatoid arthritis patients who started methotrexate

Detailed Description
-----------------
Rheumatoid arthritis patients with active disease who start subcutaneous methotrexate by their rheumatologist prescription methotrexate will be included. Patients will participate in a prospective and observational study in which the response to methotrexate will be assessed by ultrasound (US) of joints and tendons. The main objective of the study is the change in B mode and Doppler mode US after 24 weeks of methotrexate treatment.

Official Title
-----------------
Rheumatoid Arthritis Ultrasound Response to Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active rheumatoid arthritis fulfilling EULAR criteria. Prescription of methotrexate by a rheumatologist. Informed consent signed by the patient. Exclusion Criteria: None

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 |
| --- |
|Drug: Methotrexate|standard of care treatment with methotrexate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound response | Change in B mode and Doppler mode synovitis and tenosynovitis | Basal and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Change in disease activity measured by DAS28, CDAI and SDAI | Basal and 6 months | 
| Functional response | Change in functional status measured by HAQ | Basal and 6 months |
The Effect of Recruiting Inactive Blood Donors Using Different Means

Study Overview
=================
Brief Summary
-----------------
14098 inactive donors were randomly divided into three groups according to age, sex, blood donation frequency,time of last donation and blood donation site, one group acted as the control group, one will be recruited by telephone recruitment on need, and one will just be called for improvement suggestions of blood donor service.

Official Title
-----------------
The Effect of Recruiting Inactive Blood Donors Using Different Means : on Need or Just Keeping Communication

Conditions
-----------------
Blood Donors

Intervention / Treatment
-----------------
* Other: telephone recruitment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inactive donors during 2016-2018 Exclusion Criteria: inactive donors during 2016-2018 but not eligible to donate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br> | |
| Experimental: on need group<br> | Other: telephone recruitment<br>* using telephone to recruit inactive donors on two different methods<br>|
| Experimental: communication group<br> | Other: telephone recruitment<br>* using telephone to recruit inactive donors on two different methods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| donate blood or not | rate of donation after recruitment | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inactivated donors recruitment, on need ,communication