linjc16/ctgov huggingface dataset:
A Registry Study of Biomarkers in Progression of Acute Heart Failure(BIOMS-POAHF)

Study Overview
=================
Brief Summary
-----------------
The registry study aims to discover the prognostic value of bio-markers in acute heart failure

Official Title
-----------------
A Registry Study of Biomarkers in Progression of Acute Heart Failure

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients aged greater than or equal to 18 years with acute exacerbation of chronic heart failure or new heart failure 2. With typical symptoms of acute heart failure as follows: Dyspnea, ankle swelling and fatigue (Limited activity endurance), increased jugular pressure, rales and peripheral edema ; 3. Plasma concentrations of BNP: BNP>100pg/ML 4. Echocardiography: Related structural heart disease (left ventricular hypertrophy and/or left atrial enlargement) and/or diastolic dysfunction Exclusion Criteria: 1. Previous history of cancer or renal replacement therapy 2.Surgery was performed within a month 3.Accompanied by cardiogenic shock, sepsis, pneumonia 4.Eligible patients without informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of death ( all cause) or readmission for heart failure | Number of Death or heart failure related hospitalization within a median follow-up of 8.8 months of discharge | a median follow-up of 8.8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of death ( all cause) or readmission for heart failure and cardiovascular mortality | Number of Death or heart failure related hospitalization and cardiovascular mortality within a median follow-up of 8.8 months of discharge | a median follow-up of 8.8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure
Peak Flow Monitoring in Older Adults With Asthma

Study Overview
=================
Brief Summary
-----------------
Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma.

Detailed Description
-----------------
BACKGROUND: We propose a five-year Demonstration and Education project to assess the incremental value of peak flow monitoring (PFM) over symptom monitoring (SM) as a management tool for asthma control in adults greater than or equal to 50 years with moderate-severe asthma. We will develop three parallel asthma education programs for older adults using as our base an existing asthma education program (AIR/Kaiser Adult Education Program) of demonstrated efficacy for adults ,50 years of age. DESIGN NARRATIVE: Primary outcome Frequency and cost of health care utilization for asthma, and asthma-specific quality of life Key secondary outcomes Prebronchodilator FEV1; diurnal variability in PEF The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

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

Intervention / Treatment
-----------------
* Behavioral: Peak Flow Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusions: Doctor-diagnosed asthma; >=50 years; using asthma medications; >12% increase in FEV1 after two puffs of inhaled beta-agonist; willing to participate in asthma meducation program and two-year follow up; likely to stay in Portland area; KPNW member for two years. Exclusions: Unable to read, speak or understand English; no telephone; failure to keep two pre-randomization appointments; inability to reproducible FEV 1 maneuver; participation in pilot phase of study; concurrent participation in any other medical research study.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Peak Flow Monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

Study Overview
=================
Brief Summary
-----------------
In case of free flap failure, time is of utmost importance as salvage rates have been reported to be inversely related to the time interval between the onset of ischemia and its clinical recognition. Consecutively, monitoring of free flaps remains of major importance. Currently, combined Laser-Doppler and Spectrophotometry is available to determine microcirculation of free flaps in reconstructive surgery as a scientific method of reliable assessment of flap perfusion. The investigators thought to analyze the correlation of free flap skin temperature and free frap microcirculation as an accurate tool of postoperative flap monitoring.

Official Title
-----------------
Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

Conditions
-----------------
Flap Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 16 and 65 years Exclusion Criteria: soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin or equal.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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 subjects<br> | |
| Subjects suffering from Diabetes mellitus<br> | |
| Subjects suffering from peripheral arterial occlusive disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of cutaneous microcirculation to free flap temperature |  | 4 months |
ALICIA (Acalabrutinib in CLL Therapy)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for: increasing database sample size reducing bias (single institution bias) increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded. Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study. Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization

Official Title
-----------------
ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Confirmed diagnosis of CLL Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening) Capability of providing written Informed Consent Form Exclusion Criteria: Patients not corresponded to inclusion criteria Pregnancy Lactation Patients included in open-label trials Previous Bruton tyrosine kinase inhibitors (BTKI) treatment
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 |
| --- | --- | --- |
| • progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia |  | Up to 2 years | 
| • incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia |  | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic lymphocytic leukemia
Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects

Study Overview
=================
Brief Summary
-----------------
Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects

Detailed Description
-----------------
Phase 1, Open Label, Randomized, Single dose, 3 Period, 3 treatment study to evaluation the relative Bioavailability of D-0502 tablet formulation in healthy female subjects

Official Title
-----------------
A Phase 1, Open-Label, Randomized, Single Dose, 3-Period, 3-Treatment Study to Evaluate the Relative Bioavailability of D-0502 Tablet Formulations in Healthy Female Subjects

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

Intervention / Treatment
-----------------
* Drug: D-0502


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female subjects between the ages of 18-55 Required evaluation by Investigator for screening and enrollment Agreement and compliance with the study and follow-up procedures Exclusion Criteria: Significant medical history or current comorbidly determined by the Investigator. Pregnant or nursing women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Sequence 1<br>3 period, 3 dose level | Drug: D-0502<br>* Formulation 1 Formulation 2 Formulation 3<br>|
| Experimental: Sequence 2<br>3 period, 3 dose level | Drug: D-0502<br>* Formulation 1 Formulation 2 Formulation 3<br>|
| Experimental: Sequence 3<br>3 period, 3 dose level | Drug: D-0502<br>* Formulation 1 Formulation 2 Formulation 3<br>|
| Experimental: Sequence 4<br>3 period, 3 dose level | Drug: D-0502<br>* Formulation 1 Formulation 2 Formulation 3<br>|
| Experimental: Sequence 5<br>3 period, 3 dose level | Drug: D-0502<br>* Formulation 1 Formulation 2 Formulation 3<br>|
| Experimental: Sequence 6<br>3 period, 3 dose level | Drug: D-0502<br>* Formulation 1 Formulation 2 Formulation 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access the oral bioavailability of D-0502 100mg and 200mg tablets | Access the oral bioavailability of D-0502 100mg and 200mg tablets relative to D-0502 50mg tablet formulation | Single Dose, 3 period, 3 treatment study separated by 14 day washout periods to evaluate safety and bioavailability. Overall time in study is approximately 42 days. |
Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

Study Overview
=================
Brief Summary
-----------------
Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.

Detailed Description
-----------------
Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24

Official Title
-----------------
Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

Conditions
-----------------
Palpable Breast Mass

Intervention / Treatment
-----------------
* Procedure: FNA - fine needle aspiration
* Procedure: FNA - fine needle aspiration
* Procedure: FNA - fine needle aspiration
* Procedure: FNA - fine needle aspiration
* Procedure: FNA - fine needle aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any Woman with palpable Breast Mass Exclusion Criteria: Previous open Biopsy or Surgery Active infection Breast cysts Patient refusal to do FNA

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Needle 21 for FNA | Procedure: FNA - fine needle aspiration<br>* Fine Needle aspiration<br>Procedure: FNA - fine needle aspiration<br>* Fine needle aspiration<br>|
| Active Comparator: 2<br>22 needle for FNA | Procedure: FNA - fine needle aspiration<br>* Fine Needle aspiration<br>Procedure: FNA - fine needle aspiration<br>* Fine needle aspiration<br>|
| Active Comparator: 3<br>23 needle for FNA | Procedure: FNA - fine needle aspiration<br>* Fine Needle aspiration<br>Procedure: FNA - fine needle aspiration<br>* Fine needle aspiration<br>|
| Active Comparator: 4<br>24 needle for FNA | Procedure: FNA - fine needle aspiration<br>* Fine Needle aspiration<br>Procedure: FNA - fine needle aspiration<br>* Fine needle aspiration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specimen adequacy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palpable Breast Mass, FNA, Cytology, Fine needle aspiration, Specimen Adequacy
Nutritional Management of Infants With Chronic Diarrhea

Study Overview
=================
Brief Summary
-----------------
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.

Official Title
-----------------
Nutritional Management of Infants With Chronic Diarrhea

Conditions
-----------------
Growth and Tolerance Infant Study

Intervention / Treatment
-----------------
* Other: Experimental Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 12 months of age at enrollment Candidates for elemental feeding Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks Parents agree to feed infant with experimental formula for least 50% of total calories during study period Exclusion Criteria: Any non-approved concomitant study

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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: Experimental Infant Formula<br>Complete amino acid-based infant formula | Other: Experimental Infant Formula<br>* Infant formula to be fed ad libitum<br>* Other names: EleCare;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in weight from baseline. | Study Day (SD) 1, 28 and 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics | Parent completed diary of stool consistency, frequency/volume. | Study Day (SD) 2-4, 5-7, 25-27 and 81-83 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth, infants
Association of 5-HT3 Receptor Gene Polymorphism With the Efficiency of Ondansetron for Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Postoperative nausea and vomiting (PONV) is a common and distressing complication in patients undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have significantly reduced PONV, it is reported that over 35% of patients treated with ondansetron experience PONV. Though the cause of failure in ondansetron treatment is not clear, the investigators assumed that polymorphism in the 5-HT3 receptor gene would contribute to such inter-individual variation. In this study, the investigators examine whether the polymorphisms of 5-HT3 receptor gene affect the efficacy of ondansetron to prevent PONV in patients undergoing general anesthesia for laparoscopic surgery.

Conditions
-----------------
Post Operative Nausea and Vomiting

Intervention / Treatment
-----------------
* Dietary Supplement: administration of ondanstron and screening of genomic DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (20-90 years of age) scheduled for undergoing laparoscopic surgery undergoing general anesthesia Exclusion Criteria: Patients with previous history of drug allergy, administration of antiemetic drugs within 24 hours, nausea/vomiting within 24 hours and liver or kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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: Ondansetron administration group<br> | Dietary Supplement: administration of ondanstron and screening of genomic DNA<br>* Thirty minutes before the end of surgery, ondansetron 0.1 mg/kg is administered intravenously. We assess an episode of PONV at first 2 h and 2-24 h after surgery. Genomic DNA was prepared and screened. The incidence of PONV is compared among genotypes in 5-HT3 receptor gene polymorphisms (5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between the incidence of PONV after ondansetron administration and genotypes in 5-HT3 receptor gene polymorphisms ((5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG) | The incidence of PONV after ondansetron administration is compared among genotypes in 5-HT3 receptor gene polymorphisms (5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG). | at first 2 h and 2-24 h after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ondanstron, gene polymorphism, postoperative nausea and vomiting, laparoscopic surgery under general anesthesia
Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals

Study Overview
=================
Brief Summary
-----------------
The aim of the observational study was to supplement the data on efficacy, safety and tolerability of telmisartan under daily conditions in hospitals

Official Title
-----------------
Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of essential hypertension Minimum age of 18 years Exclusion Criteria: NA

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 |
| --- | --- |
| essential hypertension patients<br> | Drug: Telmisartan<br> <br> * Other names: low and high dose;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinic blood pressure |  | up to 14 days | 
| Number of patients with adverse drug reactions |  | up to 14 days |