linjc16/ctgov huggingface dataset:
Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial

Study Overview
=================
Brief Summary
-----------------
By incorporating dual-tracer PET/CT (PSMA and FDG) and ctDNA, we aimed to evaluate lesion heterogeneity and genomic change of mCRPC patients receiving novel hormonal therapy. The relationship between treatment response and different molecular characterization, as well as imaging features would also be evaluated.

Official Title
-----------------
Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial

Conditions
-----------------
Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Disease

Intervention / Treatment
-----------------
* Drug: Abiraterone
* Drug: Prednisone
* Drug: Androgen deprivation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as mCRPC according to EAU-ESTRO-SIOG 2016 and PSA > 10ng/ml; No previous treatment with novel hormonal therapy; ECOG 0-2; Normal organ function, WBC >= 3000/mm3 or Neutrophil >= 1500/mm3; Aged 18 to 85 years old when issuing written informed consent; Life expectancy > 12 months. Consent and able to carry out follow-up visit and cooperate with all other study procedures. Exclusion Criteria: Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator; Diagnosed with any other malignant tumor within 3 years before enrollment; Unable to provide necessary follow-up information; Other conditions that are judged as ineligible by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mCRPC<br>Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration. | Drug: Abiraterone<br>* Patients would be treated with 1000mg abiraterone qd.<br>Drug: Prednisone<br>* Patients would be treated with 5mg prednisone bid.<br>Drug: Androgen deprivation therapy<br>* Patients would get medical or surgical castration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion heterogeneity on dual-tracer PET/CT |  | 90 days | 
| Genomic change |  | 30 days |
SHARE - Symbicort and Health Economics in a Real Life Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.

Official Title
-----------------
Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Formoterol
* Drug: Terbutaline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, asthma, previously treated with glucocorticosteroids and B2-agonist Exclusion Criteria: History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Intervention/Treatment |
| --- |
|Drug: Budesonide|nan|
|Drug: Formoterol|nan|
|Drug: Terbutaline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days patients or assistant persons are absent from work due to patient's asthma |  |  | 
| Number of exacerbations and treatment failures |  |  |
Neurostimulation to Treat Refractory Angina Pectoris Pain

Study Overview
=================
Brief Summary
-----------------
The therapy under investigation involves an implanted Medtronic neurostimulation system to relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery.

Official Title
-----------------
STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications

Conditions
-----------------
Angina Pectoris

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (CAD) classified as Canadian Cardiovascular Society (CCS) angina class III or IV refractory angina despite receiving optimal/maximal medical treatment not a candidate for bypass surgery, angioplasty or stent Exclusion Criteria: not able to perform exercise treadmill testing previously received therapeutic transcutaneous electrical nerve stimulation (TENS) (within 2 years) or any spinal cord stimulation (SCS) has an implanted pacemaker/defibrillator (ICD)

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spinal Cord Stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angina Pectoris Pain
Multi-omics Analysis of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.

Official Title
-----------------
Multi-omics Analysis of Chronic Kidney Disease

Conditions
-----------------
Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD

Intervention / Treatment
-----------------
* Behavioral: renal function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled Exclusion Criteria: Age<18 years. Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy. Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy controls<br> | Behavioral: renal function<br>* levels of eGFR<br>|
| mild CKD<br> | Behavioral: renal function<br>* levels of eGFR<br>|
| Moderate CKD<br> | Behavioral: renal function<br>* levels of eGFR<br>|
| ESRD<br> | Behavioral: renal function<br>* levels of eGFR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism | Gut metagenome, fecal metabolome and serum metabolome were performed in this disease-severity classified CKD cohort, to identify the changes of microbial compositions and metabolism in CKD progression | baseline |
A Study Of PF-04449913 In Select Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.

Official Title
-----------------
A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF 04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Hematologic Malignancies

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: PF-04449913


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. They may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response. ECOG performance status 0 to 2 Adequate organ function Exclusion Criteria: Patients with active CNS disease Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer Active GVHD other than Grade 1 skin involvement Known malabsorption syndrome Patient has an active, life threatening or clinically significant uncontrolled systemic infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PF-04449913<br>* Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First cycle dose limiting toxicities (Phase 1a) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulation of Pharmacodynamic biomarkers |  | 12 months | 
| Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913 |  | 12 months | 
| Overall response (OR), time to progression (TTP), duration of response and progression-free survival (PFS) as defined by disease specific clinical practice guidelines |  | 12 months | 
| QTc interval |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor
Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD) patients undergoing lower extremity revascularization to describe the population and assess comparative effectiveness of endovascular therapy versus surgery. In addition, this study will conduct a prospective cohort study of patients treated medically or undergoing lower extremity revascularization at the VA and Kaiser Colorado to compare changes in health status.

Detailed Description
-----------------
Using electronic medical records, a registry of patients undergoing lower extremity revascularization therapy will be identified. Chart reviews with be done by an expert panel. The prospective cohort study will ask participants to complete health status surveys before they begin therapy for PAD and again 6 months later.

Official Title
-----------------
Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presents with PAD, > 18 years of age, can complete a questionnaire, and has either had a change in PAD lower extremity intervention or start of a new intervention (surgical, endovascular, or medical therapy (cilostazol or exercise regimen) Exclusion Criteria: dementia, inability to consent, pregnancy, limited life expectancy (< 6 months), previous endovascular or surgical revascularization within the previous 12 months, non English speaking

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 |
| --- | --- |
| Medical<br>Patients treated for PAD medically or with exercise therapy | |
| Endovascular<br>Patients with PAD treated with endovascular therapy | |
| Surgery<br>Patients with PAD treated with surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Health Status at 6 months | Health Status will be measured at baseline and six months following the procedure | Baseline (pre procedure), 6 months |
Serum Ferritin and Hepicidin Concentration in Chronic Periodontitis Patients With T2DM

Study Overview
=================
Brief Summary
-----------------
serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease

Official Title
-----------------
Decreased Ferritin And Increased Hepcidin Serum Levels In Periodontitis Patients With Diabetes Mellitus Type 2. Controlled Before-And-After Study

Conditions
-----------------
Periodontitis, Type2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm with T2DM systemically healthy patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (PPD), nearly zero plaque index (PI), gingival index (GI), zero CAL. Exclusion Criteria: (I) Pregnancy or lactation, (II) History of receiving professional periodontal treatment during the past 6 months; (III) Treatment with any type of medications and/ or antibiotics during the past 3 months and (IV) Current or former smokers.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| periodontitis<br> | |
| periodontitis with T2DM<br> | |
| control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ferritin concentration | ng/ml | 0-3 months | 
| hepicidin concentration | ng/ml | 0-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, ferritin, hepicidin, type 2 diabetes mellitus, non surgical perioontal therapy
A Study to Evaluate the Efficacy and Safety of AD-209

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-209

Detailed Description
-----------------
Condition or disease : hypertension Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2

Official Title
-----------------
A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension

Conditions
-----------------
Hypertension, Essential

Intervention / Treatment
-----------------
* Drug: AD-209
* Drug: AD-209-1A
* Drug: AD-209-1B
* Drug: AD-209-1C
* Drug: AD-209 placebo
* Drug: AD-209-1 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Other inclusions applied Exclusion Criteria: orthostatic hypotension with symptom Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>AD-209, AD-209-1 placebo | Drug: AD-209<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-209-1 placebo<br>* PO, Once daily(QD), 8weeks<br>|
| Experimental: Experimental 2<br>AD-209-1A, AD-209 placebo | Drug: AD-209-1A<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-209 placebo<br>* PO, Once daily(QD), 8weeks<br>|
| Experimental: Experimental 3<br>AD-209-1B, AD-209 placebo | Drug: AD-209-1B<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-209 placebo<br>* PO, Once daily(QD), 8weeks<br>|
| Experimental: Experimental 4<br>AD-209-1C, AD-209 placebo | Drug: AD-209-1C<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-209 placebo<br>* PO, Once daily(QD), 8weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate of MSSBP | Change from baseline in mean sitting systolic blood pressure | Baseline, Week 8 |
MRI in Ductal Carcinoma in Situ (DCIS)

Study Overview
=================
Brief Summary
-----------------
Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size

Official Title
-----------------
Relevance of Mammary MRI in the Preoperative Assessment of Ductal Carcinoma in Situ (DCIS)

Conditions
-----------------
Ductal Carcinomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 ans Woman with DCIS Exclusion Criteria: Age ≥18 ans)

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

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

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 |
| --- | --- | --- |
| The investigators compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size | Patients hospitalized at Strasbourg University Hospital in 2017 | The period from January 1st, 2017 to December 31st, 2017 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ductal carcinomas, ductal carcinoma in situ (DCIS), MRI
Dexpanthenol Mouthwash to Treat Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.

Detailed Description
-----------------
Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.

Official Title
-----------------
Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis

Conditions
-----------------
Oral Mucositis (Ulcerative) Due to Radiation

Intervention / Treatment
-----------------
* Drug: Dexpanthenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: without any systemic disease estimated survival of at least 6 months without any mental disorders grade 1 to 3 WHO mucositis Exclusion Criteria: development of grade 4 WHO mucositis Brachytherapy allergy to the drug dissatisfaction of the patient
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normal saline<br>mouth wash of normal saline ,three times a day, 10 cc each time | Drug: Dexpanthenol<br>* 5% dexpanthenol Mouth wash , three times a day, 10 cc each time<br>* Other names: Physiologic serum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of intensity of mucositis | measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort | first week (week one) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexpanthenol, Radiotherapy, chemotherapy, Mucositis