linjc16/ctgov huggingface dataset:
Medication Reconciliation in Oncologic Patients

Study Overview
=================
Brief Summary
-----------------
To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.

Detailed Description
-----------------
This trial will explore the alliance between a Cancer Institute and the community pharmacies to improve medication reconciliation in healthcare transitions, and will validate a new integrated IT platform. Cancer patients receiving an oncologic treatment will be asked to choose a pharmacy participating to the trial, and to perform the pharmacological survey before every cycle of chemotherapy. This will be sent through the new IT platform to the electronic medical record of IRST, and the Oncologist will perform the reconciliation. Data about concomitant medications and possible interactions will be exensively analyzed.

Official Title
-----------------
An Integrated Model to Increase Medication Recognition and Reconciliation in Oncologic Patients

Conditions
-----------------
Medication Reconciliation

Intervention / Treatment
-----------------
* Other: medication reconciliation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ≥18 years old Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Patients receiving an anticancer treatment Clear understanding of the Italian language; written informed consent. 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reconciliation<br>Interventional trial without drugs | Other: medication reconciliation<br>* medication reconciliation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medication recognition and reconciliation maintenance | number of reconciliations per patient | At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication reconciliation, IT platform, Pharmacies
Gender-related Differences in Chinese Patients With AAD

Study Overview
=================
Brief Summary
-----------------
Few data exist on gender-related differences in clinical features, management, and outcomes of acute aortic dissection (AAD) in China. Accordingly, we enrolled 2015 patients with AAD from 15 hospitals in China to access differences in clinical features, management and outcomes between men and women. in this study, our results provided new insights into gender-related differences in clinical features, management and outcomes in the Chinese patients with AAD. Important implications may be helpful to improve diagnostic and therapeutic outcomes.

Conditions
-----------------
Aneurysm Dissecting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute aortic dissection Exclusion Criteria: Simple dilated aneurysm and penetrating atherosclerotic ulcer

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all patients with acute aortic dissection |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic dissection, Chinese patients, gender differences
Safety of Propofol Sedation ( > 200 mg) for Colonoscopy.

Study Overview
=================
Brief Summary
-----------------
This study examines that the use of >200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy.

Detailed Description
-----------------
The hospital policy of routine discharge to normal activity 1 hour after propofol mono-sedation for EGD or colonoscopy was approved by the ethics committee of Showa Inan General Hospital in January, 2004 (http://www.sihp.jp). The investigator' s subsequent experience verified the safety of this discharge policy which was reconfirmed in March 2014. Based on these studies, the upper limit of 200 mg was established for those allowed early discharge and driving to home. This study examines that the use of >200 mg of propofol sedation enables patients to drive home safely 90-120 minutes after outpatient colonoscopy.

Official Title
-----------------
Propofol Sedation of More Than 200 mg Enables Patients to Drive Home After Outpatient Colonoscopy Including Colorectal Polypectomy

Conditions
-----------------
Safety Issues

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who drive home by theirselves after colonoscopy using propofol sedation (>200 mg) Exclusion Criteria: Subjects who received emergency procedures less than 20 years old pregnant American Society of Anesthesiologists (ASA) class III or IV, overweight (body weight >100 kg) allergic to the drugs used or its components (soybeans or eggs).

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propofol|Using > 200 mg of propofol sedation colonoscopy is performed. 90-120 minutes after colonoscopy subjects go home. Within 1 week patients will be asked about their condition and satisfaction for colonoscopy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traffic accidents | Number of traffic accidents | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction (bad, 0-good 100%) is asked. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
driving, propofol sedation, colonoscopy
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.

Official Title
-----------------
Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 positive patients who have maintained an HIV-1 viral load <200 copies/mL, for at least 3 months. Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy. HAART must consist of either: A PI (with or without ritonavir) + at least 2 NRTIs or An NNRTI + at least 2 NRTIs. Negative serum pregnancy test. Exclusion Criteria: Patients who have taken any NNRTI prior to their current therapy. Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy. Patients who are currently taking EFV+FTC+TDF. Patients who have a creatinine clearance of <60 mL/min by Cockcroft-Gault estimation. Patients who have experienced virologic failure with any previous ARV therapy. Patients who have documented resistance to any of the study agents at any time in the past.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48 |  |  | 
| Safety Outcome Measures: Adverse Events, Laboratory Tests |  |  | 
| Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS, HIV, HIV-1, Human Immunodeficiency Virus, HIV-1 Infection
Effects of Alpha-acid Lipoic in PCOS Women

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the effects of six months treatment with alpha-lipoic acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral glucose tolerance test and hormonal assays are evaluated before and after therapy.

Official Title
-----------------
Effects of 6 Months of Alpha-Lipoic Acid Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Alpha-lipoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PCOS in accordance with Rotterdam criteria Exclusion Criteria: pregnancy past history of cardiovascular diseases diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) hypertension significant liver or renal impairment other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal) neoplasms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: therapy with alpha-lipoic acid daily for six months<br> | Drug: Alpha-lipoic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cycles in six months of therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hirsutism score | Ferriman-Gallwey score | 6 months | 
| Insulin levels |  | 6 months | 
| androstenedione levels |  | 6 months | 
| testosterone levels |  | 6 months | 
| free androgen index |  | 6 months | 
| total cholesterol |  | 6 months | 
| LDL-cholesterol |  | 6 months | 
| tryglycerides levels |  | 6 months | 
| DHEAS levels |  | 6 months | 
| AMH levels |  | 6 months |
Genetic Determinants of Hemodynamic Response to Esmolol

Study Overview
=================
Brief Summary
-----------------
Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD and hypertension. However, there is large interindividual variability in the response to beta blockers. The hypothesis underlying this study is that genetic differences between individuals will determine the individual response to esmolol, a betablocker that is administered intravenously. Esmolol will be administered intravenously to healthy volunteers, and the effects on heart rate and blood pressure will be monitored. In addition, we will measure plasma renin activity and plasma levels of norepinephrine.

Official Title
-----------------
A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol

Conditions
-----------------
Decrease in Heart Rate Below Baseline Value

Intervention / Treatment
-----------------
* Drug: esmolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male and female able to understand and sign informed consent Exclusion Criteria: consumption of any medication bradycardia <50 BPM hypersensitivity to beta blockers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esmolol infusion<br>infusion of esmolol during rest and exercise | Drug: esmolol<br>* consecutive infusions of esmolol and normal saline (placebo)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate during exercise | continous measurement of heart rate | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systolic blood pressure during exercise | measurement of systolic blood pressure every 5 minutes | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart rate
Screening DIVA - Diffuse Vascular Disease

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have peripheral arterial disease (PAD) at the time of enrolment. Secondary Objective: To collect data on the prevalence of PAD in this population as measured by ABI.

Official Title
-----------------
The Value of Routine Screening for Diffuse Vascular Disease in the Canadian Post-Acute Coronary Syndrome/Ischemic Stroke/Transient Ischemic Attack General Practice Population With Previously Undocumented Peripheral Arterial Disease

Conditions
-----------------
Peripheral Vascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA) Exclusion Criteria: Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record): Non-invasive or invasive vascular diagnostic tools (e.g.: ABI, Toe-brachial index, Duplex ultrasound, Magnetic resonance angiography, Computer tomographic angiography, Contrast angiography) Previous related intervention (such as angioplasty, stenting, atherectomy, peripheral arterial bypass graft, other vascular intervention including amputation) Patients whose ABI cannot be measured accurately Patients already in a clinical trial or a product registry Hospitalized patients The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 |
| --- | --- |
| single group study<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the sensitivity and specificity of the ECQ versus ABI. |  | within 12 (+/- 2) weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9) |  | within 12 (+/- 2) weeks | 
| To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9) |  | within 12 (+/- 2) weeks |
The Relationship Between the Response to Mental Stress and Vascular Endothelial Function

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress.

Official Title
-----------------
The Relationship Between the Response to Mental Stress and Vascular Endothelial Function

Conditions
-----------------
Coronary Endothelial Dysfunction, Apical Ballooning Syndrome, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be identified in one of the four groups outlined in study population description. Exclusion Criteria: Other co-morbidities that would make the testing not possible. Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.

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 |
| --- | --- |
| Normal volunteers<br>Normal study volunteers with no prior history of coronary artery disease | |
| Apical Ballooning Syndrome<br>Women who have had a documented Apical Ballooning event as shown by coronary angiogram | |
| Coronary Endothelial Dysfunction<br>Patients who have been diagnosed with Endothelial Dysfunction via a coronary angiogram with acetylcholine challenge | |
| Myocardial Infarction<br>Women diagnosed with a Myocardial Infarction who subsequently had a Percutaneous Intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ev-AIFIB Preliminary Evaluation of the AIFib Software

Study Overview
=================
Brief Summary
-----------------
To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.

Official Title
-----------------
Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver

Conditions
-----------------
Software Performance Evaluation a Posteriori

Intervention / Treatment
-----------------
* Diagnostic Test: the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Etiology in the following list: Atrial fibrillation for which a conventional anatomical approach alone (pulmonary vein isolation) is not performed: persistent AF, long standing persistent AF paroxysmal AF (redo), paroxysmal AF Atrial tachycardia de novo or secondary to AF ablation. Exclusion Criteria: Contraindication to AF ablation Major bleeding disorder

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.|Real-time validation by an expert operator of the correct detection of atrial fibrillation driver|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Software performance evaluation a posteriori | real-time validation by the second operator of the correct detection of atrial fibrillation driver | during the ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indirect evaluation of the clinical effectiveness of the software | AF stopping rate by removal of the areas detected by the main operator and the software | during the ablation procedure |