linjc16/ctgov huggingface dataset:
Effect of a Symptom Diary on Symptom Care and Symptom Burden in Patients Treated With Chemotherapy: a Before-and-after-study

Study Overview
=================
Brief Summary
-----------------
This study investigates whether the implementation of a symptom diary for reporting and communicating chemotherapy-related symptoms improves symptom care and decreases symptom burden in adult patients treated with chemotherapy. The hypothesis is studied using a before-and-after design. First, symptom care and symptom burden will be observed in a sample of patients not being offered a symptom diary. Next, the symptom diary will be implemented at the participating hospital and symptom care and symptom burden will now be observed in a new sample of chemotherapy patients.

Official Title
-----------------
Effect of the Implementation of a Symptom Diary on the Symptom Care Received and the Symptom Burden Experienced by Adult Cancer Patients Treated With Chemotherapy: A Before-and-after-study

Conditions
-----------------
Nausea, Vomiting, Pain, Anorexia, Etcetera

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18) patients with (any type of) cancer treated with chemotherapy Understanding Dutch Being able to sign Informed consent Exclusion Criteria: More than 3 lines of chemotherapy treatment in the past

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 |
| --- | --- |
| Before group, no diary<br> | |
| After group, with symptom diary<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom distress | for each of 9 symptoms: how distressing was the symptom perceived by the patient? (ordinal variable) | T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom severity | for each of 9 symptoms: how severe was the symptom? (ordinal variable) | T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1) |
Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the occurrence of idiopathic right ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different stages of female menstrual cycle

Detailed Description
-----------------
The predilection site of idiopathic ventricular arrhythmia is right ventricular outflow tract ,which is called idiopathic RVOT arrhythmia , a retrospective study reported the females are susceptibility to this kind of arrhythmia and another questionaire survey of triggers for RVOT-VT initiation indicated that women have RVOT-A initiation with recognized states of sex hormonal flux , but few researches were made to study the exact relation between this kind of arrhythmia and sex hormone levels, this is the aim of our study .40 females with regular menses(20 females with RVOT arrhythmia ,20 healthy volunteers) will be screened, the Participants will undergo ECG monitoring and their blood samples will be collected at various times throughout the study.

Official Title
-----------------
Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle

Conditions
-----------------
Ventricular Premature Complexes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be female Aged 20 to 45 years, with regular menstrual cycles. With normal BMI Without organic heart disease Healthy volunteers and women with RVOT arrhythmia are both being recruited. Exclusion Criteria: Pregnancy Use of hormonal therapy including birth control pills or other drugs

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>subjects with right ventricular outflow tract arrhythmia | |
| control<br>subjects ,age match,healthy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number and duration of right ventricular outflow tract arrhythmia |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sex hormone levels |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
right ventricular outflow tract arrhythmia, sex hormone level, menstrual cycle, Gonadal Hormones
Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II

Study Overview
=================
Brief Summary
-----------------
Study of ORL-1F in Patients With Leukocyte Adhesion Deficiency Type II

Official Title
-----------------
Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II

Conditions
-----------------
Leukocyte Adhesion Deficiency, Type II

Intervention / Treatment
-----------------
* Drug: L-fucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Leukocyte Adhesion Deficiency Type II. Less than 18 years old. Exclusion Criteria: Diagnosis of any other disease that is not a manifestation of Leukocyte Adhesion Deficiency Type II.

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

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

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 |
| --- | --- |
| Other: Treatment with ORL-1F - L-fucose<br> | Drug: L-fucose<br>* Oral ORL-1F<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in infection frequency | Statistically significant decrease in infection frequency | 12 months after treatment started | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in neutrophil count | Statistically significant decrease in absolute neutrophil count | 30 days after treatment started |
Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers

Official Title
-----------------
Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects

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

Intervention / Treatment
-----------------
* Drug: Lu AF11167
* Drug: Itraconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects be 18 years of age and 55 years of age and with a BMI >18.5 kg/m2 and <30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating. Other pre-defined inclusion and exclusion criteria may apply.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF1167 capsule 0.5 mg<br>Single oral dose (day 1) | Drug: Lu AF11167<br> <br> |
| Experimental: Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule<br>Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8 | Drug: Lu AF11167<br> <br> Drug: Itraconazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf) |  | Day 1 and 8 | 
| Maximum observed plasma concentration (Cmax) of Lu AF11167 |  | Day 1 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf) |  | Day 1 and 8 | 
| Maximum observed plasma concentration (Cmax) of Lu AF36201 |  | Day 1 and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interaction, Lu AF11167
Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether inhalation with aerosolized amphoterin B 10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of invasive pulmonary aspergillosis.

Conditions
-----------------
Invasive Pulmonary Aspergillosis

Intervention / Treatment
-----------------
* Drug: Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65ys≥age≥18ys renal transplant recipients Exclusion Criteria: subjects with hypersensitivity to amphotericin B receipt of inhalational or intravenous amphotericin B within last 30 days subjects with known invasive fungal infection before renal transplant subjects with pneumonia

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amphotericin B|Aerosolized Amphotericin B,2mg/day or 10mg/day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive pulmonary aspergillosis |  | 3 years |
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.

Detailed Description
-----------------
The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.

Official Title
-----------------
Electrical Stimulation of the Dentate Nucleus Area (EDEN) for Improvement of Upper Extremity Hemiparesis Due to Ischemic Stroke: A Safety and Feasibility Study

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

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months) Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke) Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis) Key Exclusion Criteria: Seizures since time of stroke (i.e. seizures or seizure disorder) Unable to have an MRI (i.e. contraindicated for MRI)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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: Electrical Stimulation<br>This is a single arm study and all subjects will receive electrical stimulation. | Device: Deep Brain Stimulation<br>* Electrical stimulation of the dentate nucleus area of the cerebellum.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of study-related serious adverse events | 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DBS, Ischemic Stroke, Deep Brain Stimulation, Physical Therapy, Rehab, Brain Stimulation
Effect of Short-term Oxygen During CPET in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.

Official Title
-----------------
Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Conditions
-----------------
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, Chronic Cardiorespiratory Disease

Intervention / Treatment
-----------------
* Procedure: Supplemental oxygen via a mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: diagnosis of pulmonary arterial hypertension class I and IV (according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 week desaturate in the 6 minute walking test by at least 4% to values <92% Exclusion criteria: unstable conditions pregnant women patients with pulmonary venous hypertension patients with relevant concomitant lung disease and severe daytime hypoxemia

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental oxygen<br>Supplemental oxygen will be applied via a mask during CPET | Procedure: Supplemental oxygen via a mask<br> <br> |
| Placebo Comparator: Sham room air<br>Room air will be applied similarly to oxygen | Procedure: Supplemental oxygen via a mask<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Watt |  | 1 day | 
| exercise time |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake |  | 1 day | 
| Respiratory exchange ratio |  | 1 day | 
| ventilatory equivalent of carbon dioxide (VE/VCO2) slope |  | 1 day | 
| end-tidal pressures of carbon dioxide (PET CO2) |  | 1 day | 
| Changes in arterial blood parameters |  | 1 day |
An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints

Study Overview
=================
Brief Summary
-----------------
This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.

Official Title
-----------------
An Exploratory Single Center Study of High-dose Treatment of Glivec® in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity) Study

Conditions
-----------------
CML, Imatinib

Intervention / Treatment
-----------------
* Drug: high-dose imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS Patients who provided written informed consent prior to participation to this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: imatinib<br>Study patients will receive 400 mg twice daily oral administration in the morning and the evening. | Drug: high-dose imatinib<br>* Study patients will receive 400 mg twice daily oral administration in the morning and the evening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major molecular response | Major molecular response achieved to Month 60 from the time of Glivec treatment | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Besides Complete molecular response, complete and major cytogenetic response achieved, event-free survival, and survival without progression to AP/BC achieved to Month 60 from the time of Glivec treatment, Progression-free survival will be evaluated. | until 60 months | 
| number of adverse events | compliance status and adverse events | until 60 months |
Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease is a leading cause for morbidity and mortality in general population. The incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of incident CVD is increased by 48% in patients with RA compared to the general population. RA is associated with 50% increase in the mortality in patients with cardiovascular disease (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared with the general population. Patients with RA have a high risk of premature cardiovascular disease (CVD). The aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in RA patients.

Official Title
-----------------
Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Conditions
-----------------
Cardiovascular Diseases, Rheumatoid Arthritis, Atherosclerosis, Coronary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old (except for women till 75 years old) Absence of established CVD: Myocardial Infarction p/h PCI with balloon and/or stent Intermittent claudication PAD / intervention CAS /intervention Signed informed consent form Documented diagnosis of rheumatoid arthritis Exclusion Criteria: Known CVD Pregnancy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease risks in patient with theumatoid arthritis | Prediction of cardiovascular risks and proposed preventive treatment | 6 months |