linjc16/ctgov huggingface dataset:
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease

Study Overview
=================
Brief Summary
-----------------
To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Airways Disease

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

Intervention / Treatment
-----------------
* Drug: ATROVENT® inhalets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primarily, Patients with chronic obstructive airways disease Only patients who had not been treated with Atrovent® in the last year were to be considered for inclusion Exclusion Criteria: - Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets

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 |
| --- | --- |
| Chronic Obstructive Airways Disease<br> | Drug: ATROVENT® inhalets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile |  | Up to 4 weeks after first study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of efficacy on a 4-point scale |  | Up to 4 weeks after first study drug administration | 
| Investigator assessment of tolerability on a 4-point scale |  | Up to 4 weeks after first study drug administration | 
| Number of patients with adverse drug reactions |  | Up to 4 weeks after first study drug administration | 
| Number of patients who withdrew from the study |  | Up to 4 weeks after first study drug administration | 
| Number of patients who changed the concomitant medication |  | Up to 4 weeks after first study drug administration | 
| Number of patients who continued the treatment |  | Up to 4 weeks after first study drug administration | 
| Patient assessment of efficacy on a 4-point scale |  | Up to 4 weeks after first study drug administration | 
| Patient assessment of tolerability on a 4-point scale |  | Up to 4 weeks after first study drug administration |
A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.

Official Title
-----------------
Saudi Arabia - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment Able to comply with the study protocol 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with HER2-positive unresectable LA/mBC<br> | Other: No intervention<br>* No intervention administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | Up to 5 years | 
| Overall Survival (OS) |  | Up to 5 years | 
| Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen |  | Up to 5 years | 
| Duration of Response (DoR) Per Anti-Cancer Treatment Regimen |  | Up to 5 years | 
| Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D) |  | Up to 5 years | 
| Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) |  | Up to 5 years |
Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Study of an investigational medication for the treatment of Alzheimer's Disease in patients who are not taking Aricept, Reminyl, Exelon.

Official Title
-----------------
Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: LY451395


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a clinical diagnosis of Alzheimer's Disease Must be at least 50 years of age Must fluently read and speak English Must have a reliable caregiver Exclusion Criteria: Has serious health problems other than Alzheimer's Disease Cannot swallow whole pills Has had a menstrual period in the last two years Takes insulin for diabetes Has taken Aricept, Reminyl, or Exelon in the last 5 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY451395|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
-----------------
Alzheimer's Disease
Eye Drop Dispensers: Safety, Efficacy and Comfort.

Study Overview
=================
Brief Summary
-----------------
One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are devices that aim to ameliorate one or more of these barriers. Several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles. In this study we aim to compare the eye drops various installation aids

Detailed Description
-----------------
subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.

Official Title
-----------------
Eye Drop Dispensers: Safety, Efficacy and Comfort.

Conditions
-----------------
Glaucoma, Cataract, Healthy Subjects

Intervention / Treatment
-----------------
* Device: Eye Drop Dispenser TYPE Opticare
* Device: Eye Drop Dispenser Autodrop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma patients Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eye Drop Dispenser TYPE Opticare<br>subject will assess TYPE 1 dispenser | Device: Eye Drop Dispenser TYPE Opticare<br>* Subject will apply normal saline eye drops to them-self with various eye drop dispensers. Assessment of ease of use will be conducted by questioners.<br>|
| Active Comparator: Eye Drop Dispenser Autodrop<br>subject will assess Autodrop dispenser | Device: Eye Drop Dispenser Autodrop<br>* Eye Drop Dispenser Autodrop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of correct application of eye drops to the eye without missing conducted by questioners. | assessment of correct application of eye drops to the eye without missing | 5 seconds after instillation of eye drops | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, normal patients, eye drops dispensers, aids, glacuoma
Impact of Hyperuricemia on Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. There is currently no recommendation to treat hyperuricaemia without an episode of gout attack. We hypothesize that there is a link between hyperuricemia and severity of rheumatism. This would ultimately modify the therapeutic management of hyperuricemic patients followed for psoriatic arthritis.

Official Title
-----------------
IImpact of Hyperuricemia on Psoriatic Arthritis

Conditions
-----------------
Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC Subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist Among these two populations, all subjects for whom at least one serum uric acid assay was available in the medical file Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes Exclusion criteria: Subject who expressed their opposition to participating in the study Subject who met the inclusion criteria but whose analysis of the medical file (anamnestic, clinical, biological and radiological data) led to a diagnostic reversal and therefore did not present with psoriatic arthritis Subject under guardianship or curatorship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospectively determine the impact of hyperuricemia on the response to psoriatic arthritis treatments: inventory of the latest treatments in progress and the response to treatment according to the treating rheumatologist |  | Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriatic Arthritis, Hyperuricemia, Rheumatisms
Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after a severe injury to the sciatic nerve has occurred.

Detailed Description
-----------------
The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested either from a relatively small segment of sensory nerve or as in this case from local debridement of injured nerve at the epicenter of the nerve injury. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

Official Title
-----------------
Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair

Conditions
-----------------
Sciatic Nerve Injury

Intervention / Treatment
-----------------
* Biological: Autologous Human Schwann cells


Participation Criteria
=================
Eligibility Criteria
-----------------
- single patient with severe sciatic nerve injury enrolled under emergency request

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous Human Schwann cells|Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Asthma Exacerbations

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to gain a deeper understanding of the impact of asthma attacks on the lives of patients who experience them. This will help us to describe the true extent of the impact of asthma attacks on factors of importance to patients which have not previously been well described, including the psychological, social, financial and emotional burden of asthma attacks. Additionally, it is hoped that detailed questioning regarding features of asthma attacks from a patient perspective will improve our understanding of patient recognition of attacks, consistency of certain features of attacks and patient views regarding preventative strategies for attacks. Patient experiences of asthma attacks are poorly described in previous research. Hence this work is expected to provide useful insights into these experiences which will contribute to improvements in detecting, treating and preventing asthma attacks. The study will consist of a one-off interview lasting about 45 minutes with patients who have recently had asthma attacks. We plan to recruit patients for the study from an outpatient clinic for those who have had a recent attack or from a register of patients who have volunteered for future asthma research studies. The interviews will take place in person at the Respiratory Research Unit at the Nottingham City Hospital or over the telephone depending on patient preference.

Official Title
-----------------
Impact of Asthma Exacerbations: A Qualitative Study

Conditions
-----------------
Asthma Attack

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with previous clinician diagnosis of asthma (16 years and above) Recent (≤4 weeks) asthma attack for which patient received ≥3 days of systemic corticosteroid treatment Exclusion Criteria: Anyone under the age of 16 years. Anyone unable to speak or understand English.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Asthma with recent (<4/52) asthma attack<br> | Other: Interview<br>* Semi-structured 45 minute interviews regarding impact of asthma attacks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thematic analysis of interview transcripts using framework approach | Thematic analysis of interview transcripts using framework approach | One off 45 minute interview |
Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare levels of differnts types of microparticles circulating before and after percutaneous occluding of the left atrium by patients with atrial fibrillation and patients control. Hypothesis is that prothesis implantation will decrease levels of microparticles circulating in blood circulation because of occluding of the left atrium .

Official Title
-----------------
Evolution of Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium With Prosthesis (Amplatzer® Cardiac Plug)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: atrial fibrillation group: high embolic risk (CHADS-VASC2 score ≥4) formal and final contraindication to anticoagulant therapy no heart thrombus on ETO and TDM before percuraneous occluding control group: suspicion of stable coronary artery disease, coronary angiography scheduled and double platelet aggregation (clopidogrel and aspirine) Exclusion Criteria: for both groups congestive heart failure, severe aortic stenosis, EP or TVP early.

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 |
| --- | --- |
| Atrial fibrillation group<br>blood sampling | Other: blood sampling<br>* atrial fibrillation group:before Percutaneous Occluding of the Left Atrium, at hospital discharge and at J45 follow up control group:before coronary angiography and at hospital discharge.<br>|
| control group<br>blood sampling | Other: blood sampling<br>* atrial fibrillation group:before Percutaneous Occluding of the Left Atrium, at hospital discharge and at J45 follow up control group:before coronary angiography and at hospital discharge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of microparticles expressing phosphatidylserine in atrial fibrillation group | blood samples analized by flow cytometry | 45 days after Percutaneous Occluding of the Left Atrium. |
Long Term Outcome After Hemorrhagic Stroke Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators retrospectively reviewed all patients with neurosurgical operations for hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then telephoned the survivors for neurological and cognitive status.

Detailed Description
-----------------
Death at one year for intracerebral hemorrhage varies by location, with 42% for cerebellar in one series. Of patients who had intracerebral hemorrhage in the United States during 2002, only 20% are expected to be functionally independently at 6 months. Although case series established the value of selected timely hematoma evacuation, long term clinical outcome, especially on cognition, is not well described in the literature. With these in mind, we carried out this study.

Official Title
-----------------
Long Term Neurological and Cognitive Outcome After Neurosurgical Operation for Hemorrhagic Stroke (Intracerebral Hemorrhage)

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All hemorrhagic stroke patients with neurosurgical operations performed between 1999 and 2008. Exclusion Criteria: Spontaneous subarachnoid hemorrhage as the dominant etiology uncommunicable patients nonsurvivors

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 |
| --- | --- |
| Hemorrhagic stroke patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale |  | Cross-sectional at 2-12 years after ictus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | Basic Activity of Daily Living | Cross-sectional at 2-12 years post-ictus | 
| Telephone Interview of Cognitive Status |  | Cross-sectional at 2-12 years post-ictus | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, intracerebral hemorrhage, surgery