linjc16/ctgov huggingface dataset:
POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)

Study Overview
=================
Brief Summary
-----------------
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment

Official Title
-----------------
A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Levocetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical history of SAR known and treated since 2 years. Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year). Minimum mean T5SS of 8 during the baseline period. Exclusion Criteria: Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' satisfaction / dissatisfaction after the first week of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion), POPULAR, Xyzal, Levocetirizine
Viracept Expanded Access Program

Study Overview
=================
Brief Summary
-----------------
To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who are unable to take the three commercially available protease inhibitors (because of failure, intolerance, or contraindication) and who have a CD4 cell count of <= 50. To obtain additional information on the safety profile of nelfinavir mesylate (Viracept). (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)

Official Title
-----------------
Viracept Expanded Access Program

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. CD4 T cell count <= 100 cells/mm3. Failed, been intolerant of or had a contraindication to all three commercially available protease inhibitors (saquinavir, indinavir and ritonavir). (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.) Exclusion Criteria Prior Medication: Excluded: Prior therapy with Viracept. Required: Indinavir. Saquinavir. Ritonavir.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|nan|

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
-----------------
Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, CD4 Lymphocyte Count, Nelfinavir, Anti-HIV Agents
Exacerbating Factors in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.

Detailed Description
-----------------
Detailed questionnaires with patient in regards to potential triggers for flares of IBD. Includes both patients with flares and those in remission as a control group.

Official Title
-----------------
Exacerbating Factors in Inflammatory Bowel Disease

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of verified Crohn's disease or ulcerative colitis Exclusion Criteria: unwilling 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Flares of IBD<br>Active flare of Crohn's or UC | |
| Control Group<br>Patients with quiescent Crohn's disease or UC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of identifiable trigger for flare |  | baseline |
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients

Study Overview
=================
Brief Summary
-----------------
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data

Official Title
-----------------
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: BIOTRONIK CRT-D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date Patient successfully implanted with a left ventricular lead High likelihood of LV latency ≥ 40 ms LV lead in lateral or postero-lateral position in the coronary venous system Patient is able to understand the nature of the clinical investigation Patient is willing to undergo the required measurements at the investigation site Patient provides written informed consent Age ≥ 18 years Exclusion Criteria: Patients with irregular ventricular rhythm due to atrial tachycardia Pregnant or breast-feeding women Participation in an interventional clinical investigation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CRT-D Measurements<br>Pre-specified measurements and additional follow-ups | Device: BIOTRONIK CRT-D<br>* Pre-specified follow-up and measurements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-base measured LV latency in the LV IEGM channel and Far Field channel |  | 1 day | 
| 12-lead ECG-measured LV latency in the channel with earliest QRS onset |  | 1 day | 
| Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel |  | 1 day | 
| 12-lead ECG-measured latency intervals |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT-D, LV Latency
Inspiratory Muscle Training (IMT) in Athletes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine weather well trained athletes benefit from inspiratory (respiratory) muscle training.

Detailed Description
-----------------
Subject: The investigators intend to include 40 well trained runners, 18 years or older. Design: Following lung function and exercise testing (incremental treadmill test to exhaustion, 5000m run time trial) participants will be randomly assigned to a verum or a control group. The verum group will train with a hand-held, commercially available pressure threshold loading device (POWERbreathe,UK). The control group will perform a sham-training with the same device. After six to eight weeks the the initial tests will be repeated. Hypothesis: Inspiratory muscle training enhances performance on submaximal work loads and in the 5000m run time trial by changes in breathing pattern. Maximum oxygen uptake remains unchanged.

Official Title
-----------------
Inspiratory Muscle Training (IMT) in Athletes

Conditions
-----------------
Running Endurance

Intervention / Treatment
-----------------
* Behavioral: Respiratory muscle training
* Behavioral: Sham training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: well trained runners Exclusion Criteria: previous respiratory muscle training cardiovascular diseases impaired lung function

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training<br>respiratory muscle training (pressure threshold loading) | Behavioral: Respiratory muscle training<br>* Daily training with a handheld device (Pressure threshold loading). 1x50 breaths with adjustments (gradually increasing levels).<br>|
| Sham Comparator: sham training<br>training with low resistance | Behavioral: Sham training<br>* Sham training with same handheld device. 50 breaths daily on the lowest level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance in the 500m run time trial |  | 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum inspiratory pressure |  | 6-8- weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory muscle, breathing pattern, exercise performance
Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.

Official Title
-----------------
The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study

Conditions
-----------------
Moderate Acute Asthma

Intervention / Treatment
-----------------
* Drug: Procaterol, Salbultamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted) Patients of both gender aged 15 to 60 years Patients still have the ability to undergo examinations and give written informed consent Exclusion Criteria: Pregnant and lactating women Smokers Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases Patients with signs of severe infections

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procaterol<br>Procaterol inhalation solution 50 micro g per 0.5 mL diluted in 2mL of NaCl 0.9%, so that the volume of the inhalation solution will be similar to that of the comparator drug. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes. | Drug: Procaterol, Salbultamol<br> <br> |
| Active Comparator: Salbultamol<br>Salbultamol inhalation solution for nebulization containing 2.5 mg in 2.5 mL aqueous solution. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes. | Drug: Procaterol, Salbultamol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference 5% from baseline in peak expiratory flow rate (PEFR) |  | 3 times every 20 minutes (at 0, 20 and 40 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference 5% from baseline in asthma score |  | 3 times every 20 minutes (at 0, 20 and 40 minutes) |
Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate for the first time not only the impact of neoadjuvant chemotherapy on clinical outcome, but also on liver regeneration after liver resection.

Official Title
-----------------
Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases

Conditions
-----------------
Colorectal Liver Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver resection due to colorectal liver metastases between 2003 and 2007 Exclusion Criteria: Incomplete assessment of preoperative chemotherapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Without preoperative chemotherapy | |
| 2<br>With preoperative chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications and liver regeneration |  | 2003- July 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoadjuvant chemotherapy, clinically postoperative outcome, liver regeneration after liver resection
Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units

Detailed Description
-----------------
Hospitalized newborn in intensive care units can receive opioids to manage pain or sedation. Neonatal opioid abstinence syndrome can occur when newborn receive opioid treatment for a long time. Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items. Actigraphy allows to measure objectively the newborn motricity. This study will analyse the correlation between actigraphy and Lipsitz scoring system.

Official Title
-----------------
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

Conditions
-----------------
Neonatal Abstinence Syndrome

Intervention / Treatment
-----------------
* Device: Actigraphy, eTact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn > 22 gestation weeks Hospitalization in neonatal intensive care unit at CHU de Caen. Opioids treatment > 48 hours. Exclusion Criteria : ante or post-natal brain injury diagnosis upper arm motor deficit palliative care
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: Actigraphy<br> | Device: Actigraphy, eTact<br>* Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between actigraphy and Lipsitz scoring system | Actigraphy and Lipsitz scoring system are realized at the same time twice a day | 7 days |
Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.

Official Title
-----------------
Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses

Conditions
-----------------
Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Intervention / Treatment
-----------------
* Device: Nanoflex IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 18 years of age. Patients who have bilateral NanoFlex implantation at least 3 months previously. No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss. DCVA of 20/25 or better in both eyes. Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.87. Uncorrected VA in dominant eye 20/25 or better. Exclusion Criteria: History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity. Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation. Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).

Ages Eligible for Study
-----------------
Minimum 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nanoflex IOL<br> | Device: Nanoflex IOL<br>* Patients who were implanted with the Nanoflex IOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Near Visual Acuity |  | 1 year |