linjc16/ctgov huggingface dataset:
Ischemic Strokes While on NOAC - How Compliance Matters

Study Overview
=================
Brief Summary
-----------------
This study is aimed to depict the epidemiological trend, aetiologies, clinical characteristics, treatment options of IS-NOAC in face of the rapidly increasing NOAC usage. Knowledge on this ischaemic stroke entity will define clinical characteristics, identify preventable causes and inform resource allocation on the evaluation modalities, reperfusion strategies and forecast future burden of IS-NOAC.

Detailed Description
-----------------
Data will be retrieved from the stroke registry of Prince of Wales Hospital which recorded all in- and out-patients with stroke or transient ischaemic attack (TIA). All consecutive adult patients with known AF who developed ischaemic stroke or TIA in 2010, 2012, 2014, 2016 and 2018 (i.e. 5 full yearly time-points) and categorize the patients according to their anticoagulation status (elaborated below) with the inclusion and exclusion criteria stated will be recruited. All demographic data, blood results, imaging and assessment data will be retrieved from electronic patient record (CMS system) and stroke registry. All-cause mortality at 1 year will be verified via CMS system too.

Official Title
-----------------
Ischemic Strokes While on NOAC - How Compliance Matters

Conditions
-----------------
Stroke, Ischemic, Stroke, Acute, Stroke Syndrome, Stroke, Cardiovascular, Atherosclerosis, Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were ethnic Chinese Patients with known AF Patient who suffered from ischaemic stroke Exclusion Criteria: Patient who are non-ethnic Chinese Patient who suffered from haemorrhagic stroke

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 |
| --- | --- |
| Stroke patient<br>This is a registry-based study that will involve consecutive adult patients with known AF who developed ischaemic stroke or TIA in years 2010, 2012, 2014, 2016 and 2018. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance affects the outcomes of ischemic stroke during NOAC usage. | To depict epidemiological trend and aetiologies on different dosage of NOAC in stroke patients. | 30 Sept 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, NOAC
Photodynamic Therapy for Oral Precursor Lesions

Study Overview
=================
Brief Summary
-----------------
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.

Official Title
-----------------
A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.

Conditions
-----------------
Leukoplakia, Lichen

Intervention / Treatment
-----------------
* Other: Aminolaevulinic acid
* Other: Methylcellulose Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Existing Leukoplakia simplex SIN III (diagnostics by Biopsie) Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie) Oral Lichen planus SIN III (diagnostics by Biopsie) Good mouth hygiene status (tartar, surface) Correct seat of the prosthesis and/or the denture Located erosions in the oral cavity Minimum age:18 years Women at the age capable of child-bearing with an appropriate contraception Exclusion Criteria: Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency Pregnancy less than 18 Satisfying women No tobacco abuse satisfying therapy with local immunmodulators in lichen ruber surgical therapy of leukoplakia indicated

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminolaevulinic acid<br> | Other: Aminolaevulinic acid<br>* Photodynamic therapy<br>|
| Placebo Comparator: Placebo<br> | Other: Methylcellulose Placebo<br>* Methylcellulose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper. |  | each treatment average once a week, recall after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain due to treatment, assessed by visual analogue scale (VAS) |  | each treatment, average once a week |
Blue Light Intraocular Lenses (IOLs) and Photostress

Study Overview
=================
Brief Summary
-----------------
To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.

Official Title
-----------------
Blue Light Intraocular Lenses (IOLs) and Photostress

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery. Exclusion Criteria: Age related

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AcrySof Natural Intraocular Lens<br>AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN | |
| AcrySof clear intraocular lens<br>AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA | |
| Phakic patients<br>Phakic patients - Age matched patients who have not had cataract surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photostress Recovery Time in Seconds. | The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AcrySof IQ IOL
Evaluation of the AIIS Using Hip Ultrasound(AIISUS)

Study Overview
=================
Brief Summary
-----------------
The anatomy of the acetabulum is well described in the past literature, yet the understanding of the clinical importance of the anatomical morphology of the AIIS has grown in recent years. Hetsroni et al. (2013) proposed a morphological classification of AIIS. In this classification, three types AIIS are identified based on the relationship between the distal extension of the acetabular rim and the AIIS. Unfortunately classifying the morphology of the AIIS using standard AP pelvis examination is misleading and requires additional imagery, a specific radiographic projection - false profile pelvis or 3d imaging techniques such as CT or MRI. The objective of this study is to evaluate AIIS morphology using ultrasound as compared to golden standard (MRI)

Official Title
-----------------
Evaluation of the AIIS Using Hip Ultrasound(AIISUS)

Conditions
-----------------
AIS

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound scan of the hip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to hip related complaints Exclusion Criteria: Patient refusal Inability to consent Unavailable 3d imaging the hip joint

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US GROUP<br>All patients will first undergo ultrasound scan of the hip in attempt to recognize the AIIS, on the same day , the true morphology of the AIIS will be evaluated using 3d imaging | Diagnostic Test: ultrasound scan of the hip<br>* validation of Ultrasound test as a tool for diagosing AIIS morphology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIIS morpholgy | AIIS morphology is determined according to the hetzroni classification | through study completion, an average of 1 year |
Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).

Official Title
-----------------
Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Maytenus ilicifolia leaves infusion
* Drug: Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years being literate diagnosis of dyspepsia initial SODA score > or = 25 Exclusion Criteria: pregnancy lactation allergy to Maytenus species fail to use the drug for 3 uninterrupted weeks new onset serious adverse events, attributable to the drug patient's request

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: Maytenus<br>Tea of Martens ilicifolia leaves | Drug: Maytenus ilicifolia leaves infusion<br>* 2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks<br>|
| Active Comparator: Omeprazole<br>Omeprazole as active comparator | Drug: Omeprazole<br>* Standard therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SODA score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sydney classification |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopy, Herbal medicine, Phytotherapy
Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic fibrosis and healthy controls. II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN delivery to a mucosal surface in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is an open label study. Patients are randomized into 5 arms, each consisting of 10 healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen received during the treatment period. The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3), treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period patients receive ibuprofen orally every 12 hours (except for a control arm that receives no ibuprofen).

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

Intervention / Treatment
-----------------
* Drug: ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Confirmed diagnosis of cystic fibrosis (CF) based on: Sweat chloride greater than 60 mEq/L AND Typical pulmonary and/or gastrointestinal manifestation of CF OR Healthy volunteers --Prior/Concurrent Therapy-- At least 30 days since medications with anti-neutrophil or anti-inflammatory effect (e.g., aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], corticosteroids, macrolide antibiotics) --Patient Characteristics-- Age: Patients with cystic fibrosis (CF): 5 and over; Healthy volunteers: 18 and over Hematopoietic: No significant history of hematologic disease Hepatic: No significant history of hepatic disease Renal: No significant history of renal disease Cardiovascular: No significant history of cardiovascular disease Pulmonary: See Disease Characteristics Neurologic: No significant history of neurologic disease Other: Not pregnant; No significant history of peptic ulcer disease; Patients with CF free of any acute illness within 14 days; No prior hypersensitivity to any NSAID

Ages Eligible for Study
-----------------
Minimum Age: 5 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibuprofen|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
An Open-Label, Randomised, Parallel-Group Comparison to Investigate the Efficacy of Yasmin® (30 µg Ethinylestradiol, 3mg Drospirenone) and Marvelon® (30 µg Ethinylestradiol, 150 µg Desogestrel) on Cycle Control in Healthy Chinese Women Over 13 Cycles

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Yasmin
* Drug: Marvelon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Chinese female requesting contraceptives Exclusion Criteria: Vascular, metabolic, hepatic, renal, oncologic and other diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Yasmin<br>* 30 µg ethinylestradiol, 3mg drospirenone<br>|
| Active Comparator: Arm 2<br> | Drug: Marvelon<br>* 30 µg ethinylestradiol, 150 µg desogestrel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13. |  | 13 treatment cycles (1 cycle= 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight changes |  | 13 treatment cycles | 
| Contraceptive reliability |  | 13 treatment cycles | 
| Effects on skin condition |  | 13 treatment cycles | 
| Changes in MDQ subscale scores |  | 13 treatment cycles | 
| Adverse Events |  | the whole study period |
Aripiprazole and Effexor XR Drug Interaction Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.

Official Title
-----------------
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Venlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects, ages 18 to 45 (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. Body Mass Index (BMI) of 18 to 33 kg/m2, inclusive. Exclusion Criteria: Subjects with a decrease in SBP of >=20 mm Hg and increase in HR of >=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening. Supine BP of 90/50 mm Hg or lower at screening SBP >=140 mm Hg or DBP >=90 mm Hg at screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Venlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.<br>* Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple dose PK parameters for venlafaxine+metabolite when administered alone and with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects
Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics of ERB-041 Administered Orally to Healthy, Female Japanese Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ERB-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history and screening evaluations.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ERB-041|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, pharmacokinetics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy