linjc16/ctgov huggingface dataset:
Flutiform in Treatment of Patients With Asthma in Daily Clinical Practice.

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.

Official Title
-----------------
Flutiform Treatment in Patients With Asthma in Daily Clinical Practice; a Prospective Observational Non-interventional Study Assessing the Effect of Space Use and Adherence on Fluticasone/Formoterol FDC Efficacy Measured With the Asthma Control Questionnaire (ACQ-6).

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

Intervention / Treatment
-----------------
* Other: Observational. Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows: Patients not adequately controlled in inhaled corticosteriods and as required inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist. The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study Exclusion Criteria: There are no specific exclusion criteria as this is an observational study

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 |
| --- |
|Other: Observational. Non interventional study|Observational. Non interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice | the Asthma Control Questionnaire will be completed by subjects at study baseline and then after 12 weeks of treatment. Difference between the 2 will be the primary endpoint. | This measurement will be taken after 12 weeks of treatment |
Study of Ocular Torsion in Patients Suffering From Palsy of the Superior Rectus Extraocular Muscle

Study Overview
=================
Brief Summary
-----------------
Retrospective medical chart and medical imaging file review of patients suffering from palsy of the superior rectus extraocular muscle

Conditions
-----------------
Superior Rectus Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with unilateral muscular palsy of the superior rectus muscle Patient must have a binocular vision as characterized by Lang test Exclusion Criteria: bilateral impairment of the superior rectus muscle presence of an orbital lesion (orbital trauma, tumor or pseudo-tumor) thyroid orbitopathy No binovular vision

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 |
| --- | --- | --- |
| Excyclotorsion of the eye as measured in angle degrees by retinophotography |  | Within 1 week prior to corrective surgery |
Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.

Detailed Description
-----------------
Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery. Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.

Official Title
-----------------
Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?

Conditions
-----------------
Renal Transplant Surgery

Intervention / Treatment
-----------------
* Device: PiCCO® Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal Transplant Surgery Age ≥ 65 years Written informed consent Exclusion Criteria: Contraindications for an arterial line in the femoral artery: stents bypasses severe peripheral artery occlusive disease

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| P group<br>Group P: Fluid Management according to measurements with PiCCO® | Device: PiCCO® Monitoring<br>* Fluid and vasopressor management according to PiCCO measurements<br>|
| C group<br>Group C: Conventional fluid management | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed graft function |  | Start of anesthesia until day 7 after the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplant surgery, hemodynamic management, PiCCO, delayed graft function
Efficiency of Speech and Language Intervention on Achievement of Children With Developmental Language Disorder

Study Overview
=================
Brief Summary
-----------------
Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Thus, they have poor academic outcomes and many of these children have been maintained at least one time in a classroom, sometime more. The purpose of this project is to determine which modalities of speech and language therapy are the more efficient on academic outcomes of children with DLD. The main modalities that will be studied are the duration of speech and language intervention, the age at which begins the intervention and the intensity (number of intervention sessions per week).

Official Title
-----------------
Efficiency of Speech and Language Intervention on Achievement of Children With Developmental Language Disorder

Conditions
-----------------
Language Development Disorders, Speech and Language Disorder, Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients Have been diagnosed in the University Hospital of Amiens-Picardie with a Developmental Language Disorder patients must be aged 12 or older, patients must be agreed answering the questionnaire Exclusion Criteria: Children with a neurological pathology or handicap as epilepsy, cerebral palsy, sequelae of severe brain injury (traumatic or ischemic or inflammatory...) patients with a severe mental retardation patients with autism patients with bipolar illness patients with psychosis

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Developmental Language Disorder patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of repeated school year according length of language therapy (number of days) | Number of repeated school year according length of language therapy | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Language Development Disorders, Speech and Language Disorder, Academic outcomes
Patient Registry Study of Berinert® in Normal Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.

Official Title
-----------------
Patient Registry for Berinert®, a C1-Esterase Inhibitor

Conditions
-----------------
Includes: Hereditary Angioedema

Intervention / Treatment
-----------------
* Biological: Berinert® (C1 Esterase Inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient receiving CSL Behring's C1-esterase inhibitor Written informed consent (may not be required for some retrospective chart review cases) Exclusion Criteria: Any patient participating in an HAE study using other C1-inhibitors than Berinert®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Berinert<br>Patients requiring treatment with Berinert® | Biological: Berinert® (C1 Esterase Inhibitor)<br>* Berinert® is marketed as a lyophilized concentrate available in a single-use vial to be reconstituted with sterile water before administration as described in the prescribing information.<br>* Other names: CE1145;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thrombotic and thrombo-embolic events |  | Within 30 days of treatment with Berinert® | 
| Occurrence of suspected viral transmission |  | Duration of the study, at least 3 years | 
| Use of concomitant medications and plasma products |  | Duration of the study, at least 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C1-esterase Inhibitor, Hereditary angioedema, Acute HAE attack
Correlation Between Estimated Glomerular Filtration Rate(eGFR) and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)

Study Overview
=================
Brief Summary
-----------------
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and cardiovascular mortality. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between eGFR and vascular inflammation detected by 18F FDG-PET.

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Radiation: 18FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: absence of prior cancer diagnosis or remission from cancer at the time of PET imaging and throughout the follow-up period; >=30 years of age; no prior history of cardiovascular disease ; and absence of acute or chronic inflammatory or autoimmune disease (based on documented medical history) or use of chronic anti-inflammatory therapy. Exclusion Criteria: age <35 years presence of chronic inflammatory disease use of anti-inflammatory medications presence of active malignant cancer (defined as any radiological or pathological evidence of malignant cancer disease or undergoing chemotherapy or radiation therapy within 1 year before initial PET/CT and throughout the inter-scan duration).

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eGFR > 90<br>group whose eGFR is more than 90 | Radiation: 18FDG-PET<br> <br> |
| 60 < eGFR <90<br>group whose eGFR is between 60 and 90 | Radiation: 18FDG-PET<br> <br> |
| eGFR < 60<br>group whose eGFR is less than 60 | Radiation: 18FDG-PET<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between vascular inflammatory status measured by 18F FDG-PET and eGFR by Modification of Diet in Renal Disease(MDRD) formula |  | at 1 day of taking 18F FDG - PET | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glomerular Filtration Rate
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Study Overview
=================
Brief Summary
-----------------
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.

Official Title
-----------------
Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.

Conditions
-----------------
Hepatitis C, Chronic, Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: Sofosbuvir 400 mg and daclatasvir 60 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart Renal failure (eGFR < 30 cc/min) or under hemodialysis Exclusion Criteria: Model for End-stage Liver Disease (MELD) score > 20, Child's C (CTP score > 12), Heart rate < 50/min, Taking amiodarone

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sovodak<br>Sofosbuvir 400 mg and daclatasvir 60 mg | Drug: Sofosbuvir 400 mg and daclatasvir 60 mg<br>* Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic<br>* Other names: Sovodak;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viral Response (SVR12) | Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment | 12 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by adverse drug events | Adverse drug events recorded by direct questioning | From start of treatment to 12 weeks after end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, renal failure, sofosbuvir, daclatasvir
CDC-ATN Linkage Evaluation

Study Overview
=================
Brief Summary
-----------------
The goal of ATN 093 is to determine program-level factors associated with the effectiveness of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the various LTC programs at the AMTUs and then examining the association between the LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.

Official Title
-----------------
CDC-ATN/NICHD Testing and Linkage to Care Project

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project

Ages Eligible for Study
-----------------
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sites Implementing the LTC Program<br>This study will be conducted at the 15 ATN-funded clinical sites, known as the Adolescent Medicine Trial Units (AMTU). Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administrative Data | Program data will be electronically extracted from the LTC program records and transmitted to the ATN DOC to be used for research purposes. | Daily | 
| Primary Research Data | Collected by the ATN 093 Research Associates (RA). Will include a structured review of written materials, surveys and interviews of AMTU linkage-to-care staff, surveys of partnering agencies, and observations of LTC activities. | variable | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Linkage to care, Efficacy of linkage to care program, HIV
A Study of TRK-170 for the Treatment of Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
In Crohn's Disease Patients To evaluate the efficacy of TRK-170 To evaluate the PK characteristics of TRK-170 To assess the safety of TRK-170

Official Title
-----------------
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: TRK-170
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a diagnosis of Crohn's Disease before screening Patient has stable disease activity Exclusion Criteria: Patient has had a clinically significant illness prior to screening Patient with clinically significant deviations in laboratory values

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRK-170 Low Dose<br> | Drug: TRK-170<br> <br> |
| Experimental: TRK-170 Middle Dose<br> | Drug: TRK-170<br> <br> |
| Experimental: TRK-170 High Dose<br> | Drug: TRK-170<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's Disease Activity Index | 8 weeks (treatment), 4 weeks (follow-up) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease Activity Index, Crohn's Disease, Inflammatory Bowel Disease
Relapse Patterns in Female Cocaine Users - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in female cocaine users.

Detailed Description
-----------------
The objectives of this study were to determine the most important antecedent factors in relapse episodes and difference in the use of coping skills between relapses and close calls

Official Title
-----------------
Relapse Patterns in Female Cocaine Users

Conditions
-----------------
Cocaine-Related Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, cocaine abuse or dependency by SCIS, at least 7 days of current abstinence, cocaine use of 8 out of 30 days prior to current abstinence, ages 18-60. Exclusion Criteria: Inability to participate in a 90 day longitudinal study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine-Related Disorders