linjc16/ctgov huggingface dataset:
Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.

Official Title
-----------------
Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain

Conditions
-----------------
Malignant Melanoma Stage IV, Malignant Melanoma Stage IIIc

Intervention / Treatment
-----------------
* Drug: Trametinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have received at least one dose of dabrafenib or combination with trametinib as part of a compassionate use for the treatment of metastatic melanoma, with deadline the start of treatment the April 30, 2014. Exclusion Criteria: Patients with a history not available.

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 |
| --- | --- |
| Dabrafenib<br> | |
| Dabrafenib plus Trametinib<br>Patients treated with Dabrafenib plus Trametinib | Drug: Trametinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | Up to 18 months | 
| Adverse Event Rates | Percentage of patients developing an Adverse Event through follow-up | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Number of patients alive at the end of the follow-up period and median time between start of treatment and death. | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | 
| Resectability of tumor | Proportion of patients whom tumor was resectable | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | 
| Adherence to treatment | Proportion of patients who comply with treatment as prescribed | Participants will be followed for the duration of hospital stay, an expected average of 18 months. |
Effect of Invasive and Non Invasive Mechanical Ventilation on Feeding Delivery in COPD Elderly Patients

Study Overview
=================
Brief Summary
-----------------
COPD patients requiring ventilation may benefit from invasive or non invasive ventilation. Non invasive ventilation is often incompatible with oral or enteral feding, due to gastric dilatation and full mask therapy. At the other hand, invasive ventilation is associated with incomplete enteral feeding and nutrition requirements are not reached. The aim of the study was to compare the feeding delivery of COPD patients receiving invasive or non invasive mechanical ventilation.

Official Title
-----------------
Effect of Invasive and Non Invasive Mechanical Ventilation on the Nutritional Status of COPD Elderly Patients

Conditions
-----------------
COPD, Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients requiring mechanical ventilation (invasive and non invasive)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional intake, Mechanical ventilation, Enteral feeding
Zilver PTX Drug-Eluting Peripheral Stent Study

Study Overview
=================
Brief Summary
-----------------
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Official Title
-----------------
Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Longer Zilver PTX Stents
* Device: Shorter Zilver PTX Stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis Reference vessel diameter of 4 - 9 mm Rutherford category ≥ 2 Resting ankle brachial index < 0.9 Exclusion Criteria: Prior stent in the study vessel Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure Lacks at least one patent runoff vessel Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Longer Stents<br> | Device: Longer Zilver PTX Stents<br>* Treatment with at least one 100 mm or longer Zilver PTX stent<br>|
| Experimental: Shorter Stents<br> | Device: Shorter Zilver PTX Stents<br>* Treatment with Zilver PTX stents 80 mm or shorter only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Stent Length Upon Deployment |  | During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD
Precision Therapy in Complex High-risk Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
This is a prospective registry to enroll complex high-risk coronary heart disease patients. The purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.

Official Title
-----------------
Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bifurcation lesions with branch diameter ≥2.5mm; Chronic complete occlusion (occlusion duration ≥3 months); Left main disease; Long lesions (≥38mm); Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation); Multi-stent implantation (≥3 stents); In-stent restenosis; Moderate to severe calcification on radiography; Intermediate lesion; Thrombotic lesions; Creatinine clearance rate < 60ml/min) or on dialysis ; Left ventricular ejection fraction <40% ； History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract. Exclusion Criteria: Informed consent cannot be obtained; Life expectancy < 1 year.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intracoronary physiology and imaging-guided group<br> | Procedure: percutaneous coronary intervention<br>* Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients<br>|
| Angiography-guided group<br> | Procedure: percutaneous coronary intervention<br>* Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite ischemic events | Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization. | 24 months |
Congestive Heart Failure: Causes of Sudden Worsening

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

Detailed Description
-----------------
Congestive heart failure (CHF) presents a very significant cause of morbidity and mortality. The prevalence of CHF is between 2 and 4% and rises with age (in 70- to 80-year-old people is between 10 and 20%). CHF is the cause of 5% of all acute hospital admissions and accounts for 2% of expenses on health. The most common causes of worsening of the chronic CHF are ischemia, arrhythmias, valvular dysfunction, systemic or pulmonary hypertension, volume overload or fluid retention, high output conditions (infection, anemia, thyrotoxicosis), drugs (NSAIDs, cyclo-oxygenase (COX) inhibitors, thiazolidinediones) and medication nonadherence. The goal of this study is to determine the proportion of various reasons of acute worsening of CHF, using commonly available methods including assessment of serum drug levels.

Official Title
-----------------
Congestive Heart Failure: Causes of Sudden Worsening

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to provide informed consent aged 19 years or more history of heart failure of at least one month examined or hospitalized for acute dyspnea at rest or with minimal exertion clinical signs of fluid overload defined as at least one of following: rales jugular venous distension peripheral edema pulmonary congestion on X-ray NT-proBNP above 210 pmo/l 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 |
| --- | --- |
| Congestive heart failure<br>Patients suffering from sudden worsening of congestive heart failure | |

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
-----------------
Congestive Heart Failure, Cardiac Failure
The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey

Study Overview
=================
Brief Summary
-----------------
Cancer and cancer treatments are accompanied by several possible side effects, such as nausea, hot flashes, fatigue, drowsiness, etc. Complementary and integrative therapies, such as acupuncture, could be used to manage these symptoms. The aim of this study for our research team is to have an idea of the interest of cancer patients and caregivers in acupuncture. This is a prospective, interventional study. Cancer patients and caregivers will be approached at the day care clinic by a health care worker to participate in this study. They will be asked to complete a questionnaire about their interest in acupuncture and their motivation, what symptoms they would need it for, where they would like this acupuncture to take place, whether they are willing to pay for it, and whether they would be interested in an information session about acupuncture.

Official Title
-----------------
The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey

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

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dutch speaking patients and caregivers Patients and caregivers presenting at the outpatient clinic, including the day-care clinic and follow up visits

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Patients and caregivers are asked to complete a questionnaire | Other: Questionnaire<br>* Patients and caregivers are asked to complete a questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | At study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest in acupuncture assessed by questionnaire |  | At study inclusion | 
| Side effects participants would like to receive acupuncture for assessed by questionnaire |  | At study inclusion | 
| Place where an acupuncture treatment should take place assessed by questionnaire |  | At study inclusion | 
| Willingness to pay for an acupuncture treatment assessed by questionnaire |  | At study inclusion | 
| Interest in an information session about acupuncture assessed by questionnaire |  | At study inclusion | 
| Patient or caregiver characteristics (sex, age, diagnosis) collected by questionnaire |  | At study inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, surveys and questionnaires, patient, caregiver
Transcranial Direct Current Stimulation to Reduce Chronic Pain in Patients With Chronic Inflammatory Bowel Diseases

Study Overview
=================
Brief Summary
-----------------
In the study we test whether transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases. Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inflammatory bowel disease Chronic pain (more than 3 months) Pain (VAS > 3/10) Exclusion Criteria: Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition

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 |
| --- | --- |
| Active Comparator: Active transcranial direct current stimulation<br> | Device: Transcranial direct current stimulation<br> <br> |
| Sham Comparator: Sham transcranial direct current stimulation<br> | Device: Transcranial direct current stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain pressure threshold |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analoug scale - pain |  | 1 week |
The Effects of an Aromatic Botanical Extract on Respiratory Health.

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, double blind, placebo controlled, intervention study evaluating the effect of an aromatic botanical extract on overall respiratory health among otherwise healthy adults.

Detailed Description
-----------------
After being informed about the study and providing informed consent, patients with respiratory complaints will be randomized into a double blind placebo controlled trial of the botanical extract.

Official Title
-----------------
The Effects of an Aromatic Botanical Extract on Respiratory Health.

Conditions
-----------------
Respiratory Health

Intervention / Treatment
-----------------
* Dietary Supplement: Teramune Botanical Extract
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18-60 years currently experiencing respiratory symptoms otherwise healthy Exclusion Criteria: underlying respiratory conditions pregnant, breastfeeding, or trying to conceive tobacco use in the home allergies to any of the ingredients

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatic Extract<br>Participants receive the aromatic botanical extract orally every 4-6 waking hours for 3 days. | Dietary Supplement: Teramune Botanical Extract<br>* Combination blend of aromatic plant extracts in an emulsifier carrier.<br>|
| Placebo Comparator: Placebo<br>Participants receive the placebo matching the botanical extract orally every 4-6 waking hours for 3 days. | Other: Placebo<br>* Emulsifier carrier without active supplement ingredients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the 44-part Wisconsin Upper Respiratory Symptom Survey (WURSS-44) at day 3. | The Wisconsin Upper Respiratory Symptom Survey (WURSS-44) is a validated, self reported instrument assessing overall respiratory health. Possible scores range from 0 to 308 with lower scores indicating fewer respiratory complaints. | Baseline and Day 3 |
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Study Overview
=================
Brief Summary
-----------------
The objectives of this Post Marketing Surveillance (PMS) are: Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I) Evaluation of the time to reaching maintenance dose of pramipexole Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire

Official Title
-----------------
Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication Male of female patients of any age Exclusion Criteria: The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RLS patients<br> | Drug: Pramipexole<br> <br> * Other names: Sifrol®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of RLS symptoms (IRLS) on a 4-point rating scale |  | up to 12 weeks | 
| Change from Baseline in WPAI by means of a patient questionnaire |  | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 12 weeks | 
| Global assessment of efficacy by investigator on a 5-point scale |  | after 12 weeks | 
| Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale |  | up to 12 weeks | 
| Time to reach pramipexol maintenance dose |  | up to 12 weeks |