linjc16/ctgov huggingface dataset:
Evaluating the Use of Two Different Needles in Subjects With Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.

Official Title
-----------------
An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoFine® needle 6 mm
* Device: NovoFine® needle 8 mm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent obtained before any trial-related activities Diagnosed type 1 or type 2 diabetes Treated with insulin Exclusion Criteria: Previous participation in this trial Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation Any disease or condition which the investigator feels would interfere with the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NovoFine® needle 6 mm|nan|
|Device: NovoFine® needle 8 mm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall needle preference |  | after 2-3 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection pressure |  |  | 
| Pain perception |  |  | 
| Handling and acceptance of needles |  |  |
Medtronic Market-Released DF4 Lead Imaging

Study Overview
=================
Brief Summary
-----------------
The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation. The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.

Conditions
-----------------
Tachycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than 18 years of age. Patients able and willing to attend imaging session. Patients able and willing to give informed consent. Patients with an implanted device/lead(s) for a minimum of 3 months. Exclusion Criteria: Subjects who require a legally authorized representative to obtain consent. Subjects with exclusion criteria required by local law (e.g. age, breastfeeding Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Enrolled patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vivo lead shape |  | Six Months |
Evaluation of NT PRO BNP Guided Therapy on Hospitalization Rate and Mortality in Patients With Chronic HF NYHA II-IY

Study Overview
=================
Brief Summary
-----------------
To use continuous measurement of NT Pro BNP level as guide in therapy patients with CHF.

Detailed Description
-----------------
Group of 100 patients with CHF, NYHA II-IY will be followed for 1 years in outpatient clinic of our hospital for hospitalization, death, 6 min walking protocol, number of decompensation as a primary end point. 50 patients will be treated according usual practice in outpatient clinics and in 50 patients will be additionally used level of NT Pro BNP as additional parameter.If level NT Pro BNP will be goes down will not be changes in treatment regiment. If level of NT Pro BNP will be increased treatment will be intensified.At the end of 1 year follow up we will compare the result of two strategies.

Official Title
-----------------
Phase 1 Study of Using BNP as Guided Parameter in Treatment HF

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

Intervention / Treatment
-----------------
* Procedure: Treatment according NT Pro BNP level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older 18 y.old with CHF NYHA II-IY. Exclusion Criteria: All conditions with life expectancy less than 2 years.

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 |
| --- |
|Procedure: Treatment according NT Pro BNP level|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
-----------------
Hospitalization and death from exacerbation CHF.
The Impact of COVID-19 Pandemic on the Smoking Behaviour of Young Smokers and the Youth Quitline Service in Hong Kong

Study Overview
=================
Brief Summary
-----------------
The aims of the present study are: To explore the impact of COVID-19 pandemic on the smoking behavior of youth smokers To explore the impact of COVID-19 pandemic on the Youth Quitline service in Hong Kong

Detailed Description
-----------------
The coronavirus disease 2019 (COVID-19) pandemic has spread rapidly across the globe. According to World Health Organization (WHO), due to the harmful effects on the lungs and the possible viral transmission from fingers to mouth during smoking, tobacco use is considered a major risk factor for developing COVID-19. Both tobacco use and COVID-19 can cause damage to the cardiovascular and respiratory systems. Smokers infected with COVID-19 are at higher risk of developing severe COVID-19 symptoms or death than non-smokers. The Hong Kong SAR (HKSAR) government has announced different regulations to combat the spread of COVID-19 since late January 2020, which significantly affect the working patterns and everyday lives of people. It remains unknown how smoking habits and smoking cessation services are being affected during the pandemic.

Official Title
-----------------
The Impact of Coronavirus Disease (COVID-19) Pandemic on the Smoking Behaviour of Young Smokers and the Youth Quitline Service in Hong Kong: A Survey Study

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Other: Telephone survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hong Kong resident aged 25 or below Able to communicate in Chinese (Cantonese) Smoked in the past 30 days Exclusion Criteria: Have difficulty to communicate via telephone

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 25 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 |
| --- | --- |
| Youth smokers<br>Participants of Youth Quitline | Other: Telephone survey<br>* Participants will be asked to respond to a survey regarding their knowledge about the relationship between smoking and COVID-19, their smoking behaviors and readiness to quit during the pandemic.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking behaviors | Change in smoking behaviors of youth smokers during the pandemic | Baseline | 
| Knowledge | Knowledge regarding the relationship between COVID-19 and smoking | Baseline | 
| Readiness to quit | Change in motivation to quit during the pandemic | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Youth smokers, COVID-19, smoking behaviors
Pneumatic Sleeves and Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.

Official Title
-----------------
The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure

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

Intervention / Treatment
-----------------
* Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHF (as clinically evaluated and asessed by TTE) Gave informed consent NYHA Class II-III LVEF equal or less than 40% Exclusion Criteria: Patients who could not sign informed consent NYHA Class IV Oxygen saturation less than 90% under room air
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic Sleeves<br> | Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves<br> <br> |
| Experimental: Congestive Heart Failure Patients<br> | Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic vascular resistance |  |  |
CP-690,550 and Midazolam Drug-Drug Interaction Study

Study Overview
=================
Brief Summary
-----------------
CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.

Official Title
-----------------
A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: midazolam; CP-690,550 + midazolam
* Drug: CP-690,550 + midazolam; midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female (non-child bearing potential) subjects Exclusion Criteria: Clinically significant infections within the past 3 months History of previously untreated infection with Mycobacterium tuberculosis Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1<br> | Drug: midazolam; CP-690,550 + midazolam<br>* Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID<br>|
| Experimental: Treatment Sequence 2<br> | Drug: CP-690,550 + midazolam; midazolam<br>* Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of midazolam |  | 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax, Tmax, t1/2 of midazolam |  | 10 Days | 
| Vital signs, laboratory tests and adverse events |  | 10 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents
Human Brown Adipose Tissue and Mitochondrial Respiration

Study Overview
=================
Brief Summary
-----------------
This study is focused on measuring mitochondrial activity of human brown adipose tissue. During surgery, adipose tissue biopsies from white and brown adipose tissue will be collected from the deep neck area. These biopsies will be used to examine mitochondrial function via histological analysis, biochemical analysis and in vitro experiments based on precursor cells present in the biopsies.

Official Title
-----------------
Human Brown Adipose Tissue Histological and Mitochondrial Respiratory Analysis

Conditions
-----------------
Mitochondrial Metabolism Disorders, Adipose Tissue, Brown, Aging, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for surgery in the supraclavicular and neck region (more specific patients diagnosed with hyperparathyroidism, struma, benign thyroid gland tumours, implantation of a vagal neurostimulator for epilepsia and cervical neurologic disorders) In the thyroid gland group, euthyroid function Exclusion Criteria: Pre-operatively diagnosed malign tumour Patients undergoing acute surgery because of critical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Mitochondrial respiration in human brown | Measure of mitochondrial respiration in human brown adipose tissue biopsies and measure mitochondrial respiration in cells derived from human brown adipose tissue biopsies. With high resolution respirometry , oxygen consumption in mitochondria will be determined using different substrates that stimulate mitochondrial activity including norepinephrine which is a natural agonist to increase mitochondrial activity in brown adipose tissue. During these experiments mitochondrial complex activity can be inhibited using specific inhibitors. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterise human brown adipose tissue | Perform histological analysis and biochemical analysis in brown adipose tissue biopsies and compare to skeletal muscle. Via qPCR analysis, western blotting and immunfluorescence we will examine UCP1 expression in BAT. | 8 weeks |
A Study of ApricityRx™ for Management of IR-AEs in Patients on Immuno-Oncology Therapy

Study Overview
=================
Brief Summary
-----------------
Study of ApricityRx™ for Management of IR-AEs for patients on I-O therapy. Patients currently receiving immunotherapy will be asked to consent to participate in ApricityRx software platform mobile telephone application to report symptoms, view educational content in video form about IO and irAEs and communicate with site study team.

Official Title
-----------------
A Study of ApricityRx™ Digital Therapeutic for Management of Immune-Related Adverse Events in Patients on Immuno-Oncology Therapy

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: ApricityRx mobile application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed cancer diagnosis Prescribed treatment with immune-checkpoint inhibitor Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Uncomfortable with or unwilling to use digital or mobile technology Lack of a smart phone with compatible operating systems: iOS version 10 and above, or Android 6.0 Marshmallow Presence of any medical, psychological or social condition that, in the opinion of the investigator, would preclude participation in this study.

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 |
| --- |
|Other: ApricityRx mobile application|AE detection and monitoring software|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate digital therapeutic mobile app to capture and transmit to care team patient-generated health data and access education content on IO and irAEs | Number of times and percentage of study participants who use the app to report patient reported health data during a 12 week period and access education videos. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, immunotherapy, checkpoint inhibitors, immune-related adverse events
Responsiveness of the German Version of the Neck Disability Index (NDI-G)

Study Overview
=================
Brief Summary
-----------------
This study evaluates if the German Version of the NDI is sensitive to change over time.

Detailed Description
-----------------
Chronic neck pain patients will be asked to participate in the study. The participants are asked to fill out the NDI at the beginning of the study and after seven weeks. Additionally the participants will fill out the PGIC.

Official Title
-----------------
Responsiveness of the German Version of the Neck Disability Index (NDI-G)

Conditions
-----------------
Neck Pain Chronic

Intervention / Treatment
-----------------
* Other: Manual Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic neck pain over 18 years old informed consent able to speak, write and read German. Exclusion Criteria: Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures

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: Manual Therapy|The treatment the patients receive is not specifically set up for the study. Participants will already be seeing a practitioner before the participants are included in the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the German Version of the Neck Disability Index (NDI-G) | Questionnaire to evaluate the subjective restriction of the participants | Change from Baseline to seven weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change Scale (PGIC) | Questionnaire measuring the change of the patient. | Seven weeks after the baseline measurement |
Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

Study Overview
=================
Brief Summary
-----------------
Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.

Official Title
-----------------
A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

Conditions
-----------------
Glycogen Storage Disease Type II

Intervention / Treatment
-----------------
* Biological: Myozyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol The patient must have completed Protocol AGLU01602. Exclusion Criteria: Patient has experienced any unmanageable adverse event (AE) in Protocol AGLU01602 due to Myozyme that would preclude continuing treatment with Myozyme
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Myozyme<br>* 20 mg/kg qow or 40 mg/kg qow<br>* Other names: alglucosidase alfa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Safety and Efficacy |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycogen Storage Disease Type II, GSD-II, Pompe Disease, Pompe Disease (Late-onset), Acid Maltase Deficiency Disease, Glycogenosis 2, Glycogen Storage Disease Type II (GSD-II)