linjc16/ctgov huggingface dataset:
Medication Adherence in Heart Failure After Hospitalisation

Study Overview
=================
Brief Summary
-----------------
To explore medication adherence in patients who were hospitalised due to heart failure.

Official Title
-----------------
Study Title Medikamentenadhärenz Bei Erwachsenen Personen Mit Herzinsuffizienz

Conditions
-----------------
Adherence, Medication, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Heart failure Hospitalisation due to heart failure in the past two years Exclusion Criteria: Not speaking German cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 118 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 |
| --- | --- | --- |
| Medication Adherence | MARS-5 5-Item Medication Adherence Rating Scale | at one timepoint (cross sectional) |
Evaluation of Reader Training Processes

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.

Official Title
-----------------
Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: florbetapir F 18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Scan obtained for clinical reasons Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Practice Scans<br>Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans. | Drug: florbetapir F 18<br>* No study drug will be administered in this study - scans previously acquired in the course of clinical practice.<br>* Other names: florbetapir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement Between Expert Panel and Clinical Practice Reads | Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers. | Scan acquired 50-60 minutes post injection |
The Prognostic Value of Serum Biomarkers in Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
Observational retrospective cohort study using laboratory data of blood tests prior to surgical and chemotherapy treatment and other histologic, clinical, and instrumental data related to patient history from digitized medical records and analysis of the same as predictors of outcomes.

Official Title
-----------------
The Prognostic Value of Serum Biomarkers in Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Other: case series review of clinical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteosarcoma diagnosed at the Pathological Anatomy of the Rizzoli Orthopaedic Institute in Bologna; Minimum 2-year follow-up period; Medical records, complete blood work and instrumental examinations, regular follow-up; Patients with age ≥ 2 years; Exclusion Criteria: Patients with osteosarcoma who have received medical treatment (surgery, radiotherapy or chemotherapy) in other hospitals prior to admission to our Institute

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: case series review of clinical data|Extraction of pre-surgical and chemotherapy blood test laboratory data and clinical and instrumental data related to patient history from digitized medical records and analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of 5-year survival | Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental prognostic factors | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the rate of local recurrence | Evaluation of the rate of local recurrence and distant metastasis in relation to histological, laboratory, clinical, and instrumental prognostic factors. | 5 years |
IRIS-Firehawk® Cohort in the IRIS-DES Registry

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate effectiveness and safety of Firehawk® stent in the real world daily practice as compared with other drug-eluting stents.

Official Title
-----------------
Evaluation of Effectiveness and Safety of Firehawk® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
-----------------
Coronary Stenosis, Coronary Disease

Intervention / Treatment
-----------------
* Device: Firehawk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Patient with Firehawk® coronary stent Exclusion Criteria: Intervention with Firehawk® coronary stent and other drug eluting stent at the same time Life-expectancy less than 1 year Cardiac shock

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 |
| --- | --- |
| Coronary Stenosis<br> | Device: Firehawk<br>* Firehawk stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 5 year | 
| Cardiac death |  | 5 year | 
| Myocardial Infarction |  | 5 year | 
| Composite event rate of death or myocardial infarction (MI) |  | 5 year | 
| Composite event rate of cardiac death or myocardial infarction (MI) |  | 5 year | 
| Target- Vessel Revascularization |  | 5 year | 
| Target- Lesion Revascularization |  | 5 year | 
| Stent thrombosis |  | 5 year | 
| Procedural Success rate | Procedural success rate is defined as < 30% final stenosis and the absence of in-hospital event including death, Q wave myocardial infarction, urgent repeat revascularization. | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Firehawk, Coronary Artery Disease, Drug Eluting Stent
Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of 2 treatments to prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds that are common in patients with weak immune systems or transplant patients. AmBisome, a new treatment, will be compared to fluconazole, the traditional treatment for fungal infections caused by the yeast Candida. Treatment will only be given to liver transplant patients who are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI will be monitored but will receive no study medication. IFIs are found mainly in a high risk group of liver transplant patients, and are not common in those with low risk. If IFI preventive therapy is focused on the high risk group, there may be a lesser chance of Candida becoming resistant (able to grow despite the presence of drugs used to kill it). Treating only the high risk group will also save money.

Detailed Description
-----------------
If you are in the high risk group you will be assigned randomly (like tossing a coin) to receive either AmBisome or fluconazole. If you are in the low risk group, you will not receive any treatment. Both groups will be monitored for IFIs. The study will last for 100 days following your liver transplant.

Official Title
-----------------
Invasive Fungal Infection in Liver Transplant Recipients: A Randomized Double-Blind Trial Comparing AmBisome and Fluconazole in the High Risk Group and an Observational Cohort Study in the Low Risk

Conditions
-----------------
Candidiasis

Intervention / Treatment
-----------------
* Drug: Fluconazole
* Drug: AmBisome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You may be eligible for this study if you: Have had a liver transplant within 5 days of enrollment and agree to receive tacrolimus. Exclusion Criteria: You will not be eligible for this study if you: Are HIV-positive. Have a history of invasive fungal infection. Have received antifungal agents within 14 days prior to your liver transplant. Are allergic to azoles, amphotericin B, or tacrolimus.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluconazole|nan|
|Drug: AmBisome|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Official Title
-----------------
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Conditions
-----------------
Osteearthritis

Intervention / Treatment
-----------------
* Drug: Diclofenac Topical Sodium Gel 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion criteria OA of the knee Key Exclusion criteria Other rheumatic disease, such as rheumatoid arthritis Active gastrointestinal ulcer during the last year Known allergy to analgesic drugs

Ages Eligible for Study
-----------------
Minimum Age: 35 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

| Intervention/Treatment |
| --- |
|Drug: Diclofenac Topical Sodium Gel 1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain score in target knee at Week 12 |  |  | 
| WOMAC physical function score in target knee at Week 12 |  |  | 
| Global rating of disease activity by patient at Week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8 |  |  | 
| WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12 |  |  | 
| Pain on movement in target knee and use of rescue medication recorded in diary |  |  | 
| Global evaluation of treatment at final visit |  |  | 
| Treatment responder rate according to OARSI criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Staffing Patterns of Comprehensive Primary Care Practices

Study Overview
=================
Brief Summary
-----------------
Examines staff size and composition of the 496 advanced primary care practices participating in CMS's comprehensive primary care initiative, in 7 regions (states or local areas) that were selected for the demonstration.

Detailed Description
-----------------
Participating practices all have electronic health records, submitted applications to participate in this demonstration program designed to improve primary care practices, and were selected as the most advanced of the applicants in terms of use of health information technology and certification as a medical home or possessing features similar to those of a medical home. Participating practices will receive monthly payments from Centers for Medicare & Medicaid (CMS) for Medicare patients attributed to the practice, and from other payers in the market taht are participating in the initiative. The demonstration began in October 2012 and will continue for 4 years. This early paper focuses on describing these practices at the outset of the demonstration.

Official Title
-----------------
Evaluation of the Comprehensive Primary Care Initiative

Conditions
-----------------
Medicare Expenditures and Hospital Use, All Conditions

Intervention / Treatment
-----------------
* Other: Comprehensive primary care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Medicare fee-for-service patients who receive the majority of their Evaluation and Management visits from one of the study practices. 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 |
| --- | --- |
| Comprehensive primary care practices<br>Comprehensive primary care practices are the intervention group. | Other: Comprehensive primary care<br>* Practices participating in the comprehensive primary care initiative receive a monthly amount from Centers for Medicare and Medicaid Services for each attributed Medicare patient, plus technical support of a learning collaborative, and can share in any net savings generated.<br>|
| Comparison practices<br>Comparison practices are the case-control group--the matched set of practices in a comparison area--whose patients' outcomes will be compared to those of intervention practices. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medicare expenditures per year for patients attributed to the practice |  | Four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of preventable hospitalizations |  | four years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, Medicare costs, hospitalizations
Ascitic Fluid Microbiome in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP). All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.

Conditions
-----------------
Ascitic Fluid, Microbiota, Microbiota, Sequence Analysis, Polymerase Chain Reaction

Intervention / Treatment
-----------------
* Other: Ascitic fluid puncture
* Other: Skin swaps from puncture side
* Other: Stool samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underlying decompensated liver cirrhosis routinely performed ascitic fluid puncture informed consent Exclusion Criteria: -

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 |
| --- | --- |
| Patients with liver cirrhosis and with SBP<br> | Other: Ascitic fluid puncture<br> <br> Other: Skin swaps from puncture side<br> <br> Other: Stool samples<br> <br> |
| Patients with liver cirrhosis and without SBP<br> | Other: Ascitic fluid puncture<br> <br> Other: Skin swaps from puncture side<br> <br> Other: Stool samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Next generation sequencing results from ascitic fluid samples |  | 1 year |
Oropharynx (OPX) Salivary Biomarker Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to analyze certain biomarkers to look at the relationship between HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of non-cancerous participants.

Official Title
-----------------
Oropharynx (OPX) Salivary Biomarker Study: Microbiome, Virome, and Metabolomics

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

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036). Normal Controls: Age ≥ 18 years; Able to provide informed written consent documenting permission to give saliva sample for research testing.; Ability to complete questionnaire(s) by themselves or with assistance. Exclusion Criteria: Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036). Normal Controls: Any personal history of head or neck cancer including head or neck skin cancer. Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, non-metastatic prostate cancer. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer. Dry mouth (xerostomia) caused by any chronic (>30 days) condition (known or unknown) or medication. Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Normal Saliva<br>saliva from normal healthy adults. | Other: no intervention<br>* saliva collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncologic strains in HPV DNA salivary samples | Number of patients to have oncologic strains of HPV DNA in salivary samples | 2 years |
Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fasting conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Intervention/Treatment |
| --- |
|Drug: Ramipril|10 mg capsule|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, two-period, 7 day washout |
Furosemide Inhalation in Dyspnea of Mustard Gas Exposed Patients

Study Overview
=================
Brief Summary
-----------------
to assess the efficacy of inhaled furosemide in mustard gas exposed patients with acute respiratory failure

Official Title
-----------------
Furosemide Inhalation in Dyspnea of Mustard Gas Exposed Patients: a Double-Blind Randomized Study

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: furosemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of exposure to sulfur mustard with a complaint of dyspnea Exclusion Criteria: A contraindication for furosemide use; An accompanying disease in which other drugs effective for dyspnea were used

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 83 Years

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: furosemide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of furosemid inhalation on dyspnea |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
furosemide, inhalation, dyspnea, spirometry, mustard gas, bronchiolitis, sulfur mustard