linjc16/ctgov huggingface dataset:
An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

Official Title
-----------------
FAct: A Non-interventional Multi-center Study to Follow Patients Starting With RoActemra Assessing the Long Term Efficacy, Effectiveness and Safety of RoActemra

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >18 years of age Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra Exclusion Criteria: Contra-indications for RoActemra/Actemra

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity score (DAS 28) |  | baseline and up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disability, assessed by Health Assessment Questionnaire (HAQ) |  | baseline and up to 4 years | 
| Change in concomitant medication (especially tapering of steroids) |  | baseline and up to 4 years | 
| Change in dosage schedule (modification/interruption/discontinuation) |  | baseline and up to 4 years | 
| Safety: Incidence of adverse events |  | up to 4 years | 
| Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness) |  | up to 4 years |
PK of Depo SubQ Injected in the Upper Arm

Study Overview
=================
Brief Summary
-----------------
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

Detailed Description
-----------------
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm

Official Title
-----------------
Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm

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

Intervention / Treatment
-----------------
* Drug: Medroxyprogesterone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-40 negative pregnancy test on day of injection not wishing to become pregnant in the next 12 months at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD) body mass index of 18-30 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medroxyprogesterone acetate<br>Single injection of Medroxyprogesterone acetate (hormonal contraceptive) | Drug: Medroxyprogesterone acetate<br>* Injectable hormonal contraceptive<br>* Other names: Depo-SubQ Provera 104;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) |  | 120 days following injection | 
| Tmax (Time to Cmax) |  | 120 days following injection | 
| AUC 0-91 (Area Under Curve) |  | first 91 days following injection | 
| MPA Concentration at Day 91 (C91) |  | day 91 after first injection | 
| MPA Concentration at Day 104 (C104) |  | day 104 after injection | 
| MPA Concentration at Day 120 (C120) |  | day 120 after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AE adverse event, DCF data collection forms, DMC Data Monitoring Committee, FDA U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU International units, mg milligram(s), SAE serious adverse event, µg microgram, ULN upper limit of the normal range
A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose concentration).

Official Title
-----------------
A Double Blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-00915275 After Oral Administration To Subjects With Type 2 Diabetes Mellitus For 4-Weeks

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: PF-00915275


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus HbA1c > 7.5%. Exclusion Criteria: Recent (within the past 12 months) evidence or history of unstable concomitant disease. Treatment with any oral hypoglycemic agent within 3 months before enrollment. The exception to these criteria is that subjects who are currently taking metformin hydrochloride, in a stable dose (that is no changes in dose) for treatment of their diabetes within the past 3 months or longer of enrollment may participate.

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: PF-00915275|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is glucose lowering (24 hour mean glucose concentration). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose |  |  |
The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood

Study Overview
=================
Brief Summary
-----------------
The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults.

Detailed Description
-----------------
The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series are building blocks of all cell membranes and are found in high concentrations in retina and brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision with the long-chained omega-3 molecules depends primarily on individual eating habits. While AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations only in certain species of fatty fish, such as salmon or mackerel. The study investigates whether participants receiving an omega-3 supplement over a period of 4 month, perform better on a series of cognitive tests, than the participants allocated to the placebo group.

Official Title
-----------------
The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood of Healthy Young Adults

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

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young adults Exclusion Criteria: Coagulation disorder

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 24 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>1: omega-3 fatty acid supplement | Dietary Supplement: Omega-3 fatty acids<br>* 600 mg EPA 120mg DHA daily, 16 weeks<br>|
| Placebo Comparator: 2<br>2: olive oil | Dietary Supplement: Omega-3 fatty acids<br>* 600 mg EPA 120mg DHA daily, 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition |  | Before intervention and after 16 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood |  | Before intervention and after 16 weeks of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Young adults, Long-chain polyunsaturated fatty acids, Cognitive function, Mood, Supply with omega-3 fatty acids
Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography

Study Overview
=================
Brief Summary
-----------------
Study and assessment of characteristic changes in foveal avascular zone during different stages of diabetic retinopathy using OCTA.

Detailed Description
-----------------
OCTA is superior to other retinal imaging techniques like fluorescein angiography(FA) as it does not require dye injection, Intravenous dye injection is time consuming and can have adverse side effects. Furthermore, the edges of the capillaries can become blurred due to dye leakage and imaging of the retina can only be 2D when using FA. OCTA provides both structural and functional (i.e. blood flow) information in tandem. The corresponding OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology. In diabetic retinopathy OCTA can show choriocapillaris abnormalities and/or retinal microvascular abnormalities such as microaneurysms, vascular remodeling adjacent to the foveal avascular zone (FAZ), enlarged FAZ, and capillary tortuosity and dilation through different stages. OCTA can show smaller vascular changes not detectable by FA.

Official Title
-----------------
Quantitative and Qualitative Analysis of Foveal Avascular Zone Characteristics in Different Stages of Diabetic Retinopathy Using Optical Coherence Tomography Angiography (OCT-A)

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Device: OCT angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients suffering from different stages of diabetic retinopathy. Exclusion Criteria: Other ocular problems affecting vision including glaucoma, cataract, amblyopia, hypertensive retinopathy, vein occlusion and uveitis.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Other: A<br> | Device: OCT angiography<br>* OCT angiography of foveal avascular zone in diabetic retinopathy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses | analysis of foveal avascular zone in different stages of diabetic retinopathy using OCT angiography | baseline |
Af Ablation In Brady-Tachy Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden. The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.

Detailed Description
-----------------
The study is a randomized study 1:1 AF ablation vs non AF ablation. Patients are followed for 1 year. 38 patients will be required to show a significant reduction in AF burden.

Official Title
-----------------
Af Ablation In Brady-Tachy Syndrome

Conditions
-----------------
Brady-tachy Syndrome

Intervention / Treatment
-----------------
* Procedure: AF ablation + pacemaker implantation
* Procedure: Pacemaker implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paroxystic AF symptomatic pauses (>5s at night or 3s during daytime) Exclusion Criteria: permanent AF age > 80 y pregnant women minors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: 1<br>AF ablation + pacemaker | Procedure: AF ablation + pacemaker implantation<br>* regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)<br>|
| Active Comparator: 2<br>Pacemaker | Procedure: Pacemaker implantation<br>* regular pacemaker implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF burden |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brady-tachy syndrome, AF ablation
A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single centre, open-label study will investigate the effect of RO4917838 on the pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers. Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of Rosuvastatin.

Official Title
-----------------
A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO4917838 and Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteers, 18 to 65 years of age A body mass index (BMI) between 18 to 30 kg/m2 Exclusion Criteria: History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis (Gilbert's Syndrome is allowed) Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO4917838 and Rosuvastatin<br>* multiple oral doses of RO4917838 and single oral dose of Rosuvastatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination |  | 30 days | 
| To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838 |  | 30 days |
Efficacy and Safety of Extracorporeal Biofeedback

Study Overview
=================
Brief Summary
-----------------
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.

Official Title
-----------------
Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence

Conditions
-----------------
Female Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: PFMT with Extracorporeal Biofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with stress urinary incontinence Standard pad test > 2gram Exclusion Criteria: Women with: Mixed urinary incontinence of which urgency incontinence is dominant True incontinence Overflow incontinence Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function Pelvic organ prolapse which the stage is at least 2 Proven urinary tract infection during screening period Pacemaker Pregnant women Neurogenic voiding dysfunction

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

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

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: PFMT with Extracorporeal Biobeedback<br> | Device: PFMT with Extracorporeal Biofeedback<br>* Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks Twice a week for the first 4 weeks Once a week for the next 8 weeks<br>* Other names: HnJ-5300;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test. |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength. |  | After 12 weeks of treatment | 
| Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW). |  | After 12 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Floor Muscle Training, Extracorporeal Biofeedback
Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma

Official Title
-----------------
Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK)

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Drug: Single corticosteroid inhalers and Singulair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-64 Clinical diagnosis of Asthma Glucocorticoid treatment > 6 months. Verified Allergy Read and speak Swedish Exclusion Criteria: Smoking Current regular treatment with long-acting beta2-agonist Treatment with Singulair only or in combination with glucocorticoids Taking part in other research study Pregnancy or breast-feeding Unstable Asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Symptom-guided group<br>Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use. | Drug: Single corticosteroid inhalers and Singulair<br>* Treatment steps according to preset algorithm<br>|
| Active Comparator: FeNO-guided group<br>Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide | Drug: Single corticosteroid inhalers and Singulair<br>* Treatment steps according to preset algorithm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-AQLQ (Asthma-Related Quality of Life) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Allergy, Cytokines, Glucocorticoids, Inflammation, Nitric Oxide (NO), Quality of Life, Self-Rated Health, Stress