linjc16/ctgov huggingface dataset:
Study for Atrial Fibrillation Reduction (SAFARI)

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat. People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).

Official Title
-----------------
Study for Atrial Fibrillation Reduction (SAFARI)

Conditions
-----------------
Atrial Fibrillation, Bradycardia

Intervention / Treatment
-----------------
* Device: Pacing Algorithms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a slow heartbeat who are in need of dual chamber pacing (pacing in both the atrium and ventricle). Subjects who have experienced at least two episodes of rapid heart beats three months prior to enrollment. Exclusion Criteria: Subjects who have a history of permanent (chronic) or persistent (non self-terminating) atrial fibrillation. Subjects with atrial fibrillation due to reversible cause, (e.g. thyroid disease, pericarditis, post-surgery, alcohol abuse). Subjects with a history of one or more cardioversions (changing an abnormal heart rhythm into a normal one by either using medication or by the application of an electric shock) six months prior to enrollment.
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pacing Algorithms|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Atrial Fibrillation/Therapy
Critical Care and Palliative Care Medicine Together in the ICU

Study Overview
=================
Brief Summary
-----------------
Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.

Official Title
-----------------
Does Early vs Usual Palliative Care Consultation Augment the Critical Care Physician to Decrease Healthcare Utilization and Increase Caregiver Satisfaction

Conditions
-----------------
Palliative Care, Intensive Care Unit, Hospice

Intervention / Treatment
-----------------
* Other: Palliative Care Consult


Participation Criteria
=================
Eligibility Criteria
-----------------
Age >80 years Apache II score >14 SOFA score > 9 Pre-existing functional dependency (admitted from ALF, SNF, LTAC, etc.) Late stage dementia (bed-bound, nonverbal, incontinent, or unable to self-nourish/tube feed) Stage 4 metastatic disease Consideration to place permanent feeding tube or trach Recurrent ICU admissions in the past year Post-cardiac arrest End-stage disease (lung, ESRD, ESLD) ICU perceived need

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Standard care with consultant discretion regarding consult of palliative care medicine | |
| Experimental: Experimental<br>Early palliative care consult based upon meeting study inclusion criteria | Other: Palliative Care Consult<br>* Consult of hospital palliative care service for those meeting study inclusion criteria<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Measure will assessed by using the family satisfaction with care in the intensive care unit form (FS-ICU 24) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | 1 year | 
| Ventilator Days |  | 1 year | 
| Percentage admission to hospice |  | 1 year |
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications

Study Overview
=================
Brief Summary
-----------------
Objective- The purpose of this study is to evaluate a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic operational wounds and its relation to infections and seroma formation.

Detailed Description
-----------------
our objective is evaluation of a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacum drains of different plastic operational wounds and its relation to infections and seroma formation. it is possible that early changes in this values might point out an infection or seroma formation of a wound before clinical signs appear.

Official Title
-----------------
Acid Base and Electrolytes Patterns in Drains of Different Operational Wounds and Its Relation to Specific Infections and Seroma Formation

Conditions
-----------------
Wounds, Infections, Seroma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all post operational patients who have a vacum drain/s Exclusion Criteria: patients who are unable to sign a Consent Form (demented,Alzheimer's disease ...) patients who refuse participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Histological confirmation |  | end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vacum drains, operational wounds, infections, seroma, acid base, glucose, lactate
The Effect of Final Exam Preparation on Anxiety Level, Self-Perception, Ocular Symptoms, Accommodation and Vergence in Myopia

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of exam preparation on anxiety level, self perception, ocular symptoms and oculomotor responses in myopes

Detailed Description
-----------------
Twenty two first year optometry students were evaluated towards the end of their first academic year on a battery of Oculomotor and Survey tests. This occurred during two sessions, one Low Stress session and one High Stress session. Sessions were separated by one month. Low Stress Session (LS), No Exams or Minor Exams High Stress Session (HS), Final Exam Preparation week Battery of Surveys: Adult Manifest Anxiety Scale for College Students (AMAS-C): 36 items which probe 4 types of anxiety Worry/Oversensitivity Test Anxiety Physiological Anxiety (Somatic responses to anxiety) Social Concerns Self Perception Profile (SPP): 45 items which probe 9 domains Scholastic Competence Social Acceptance Athletic Competence Physical Appearance Job Competence Romantic Appeal Behavioral Conduct Close Friendship Global Self-worth CI Symptom Survey (CISS-15): 15 items which probe ocular and aesthenopic signs and symptoms Students also reported Hours of daily near work (NWhrs). Battery of Oculomotor Tests: (20/30 ETDRS target used for all) Vergence Tests Phorias Near and Far (Neutralized Alternate Cover Test) Vergence Ranges Near and Far (Prism Bar) Vergence Facility Near and Far (3BI/12BO) Near Point of Convergence Objective Accommodative Tests (SRW-5000autorefractor) Monocular Accommodative Responses to: Near Target (33cm) Minus Lens (-3D) while viewing distant (6m) target Subjective Accommodative Tests: Monocular Accommodative Responses to: Donder's Push Up Amplitude test Near Accommodative Facility (+/-2.00, five practice trials) Distant Accommodative Facility (plano/-2.00, five practice trials)

Conditions
-----------------
Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any first year optometry student Exclusion Criteria: Previous Refractive surgery, amblyopia, strabismus, RGP wearer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, anxiety, myopia progression, accommodation, vergence
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Conditions
-----------------
Adverse Events, Pharmacokinetic Variables

Intervention / Treatment
-----------------
* Drug: ABT-143
* Drug: ABT-335 and rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Condition of good health Exclusion Criteria: Currently enrolled in another study Females who are pregnant or breast feeding

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ABT-143 15/135mg | Drug: ABT-143<br>* once<br>|
| Active Comparator: B<br>ABT-335 135mg and rosuvastatin 15mg | Drug: ABT-335 and rosuvastatin<br>* once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and safety laboratory assessments |  | 7 days | 
| Pharmacokinetic parameters |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse events, Pharmacokinetic variables
Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life

Study Overview
=================
Brief Summary
-----------------
The main objective of this study was to determine the frequency of the practice of colonic irrigation (CI) among patients with a colostomy,. Other objectives are: To compare the quality of life between a group of patients with a colostomy and practicing CI versus a group of patients with a colostomy without CI. To determine the causes of non-realization of the CI or failure. To determine the conditions of realization of colonic irrigation by the return of user experience (time of day when the CI is practiced, amount and type of fluid used, time spent in the bathroom, time to recurrence of stool, media used between two irrigations).

Official Title
-----------------
Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life

Conditions
-----------------
Colostomy

Intervention / Treatment
-----------------
* Behavioral: practice of colonic irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject was informed about the implementation of the study's objectives, constraints and the rights of the subject The subject is aged at least 18 years The subject is a member of the Ostomy Federation of France The subject has had a terminal colostomy for more than 6 months Exclusion Criteria: The subject is under guardianship or curatorship The subject is under judicial protection The subject formalizes his/her opposition It is not possible to inform the subject

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 |
| --- |
|Behavioral: practice of colonic irrigation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Practice of large bowel irrigation (yes/no) | Does the patient practice large bowel irrigation? (yes/no) | Day 0 |
Study of Pulmozyme to Treat Severe Asthma Episodes

Study Overview
=================
Brief Summary
-----------------
Even with current standard ED treatments 20-25% of patients presenting to the ED with an acute asthma episode will still require hospitalization. For patients unresponsive to beta-agonists the admit rates will be higher. Of those well enough to be discharged from the ED nearly 30% will relapse within one month. More than 5,000 patients with asthma still die each year in the USA. For patients who do not respond to beta-agonists, there are relatively few treatment options for rapid improvement of symptoms and pulmonary function. Presumably, mucous secretion and plugging play an important role in the pathogenesis of severe asthma unresponsive to beta-agonists. The use of agents to promote clearance of intra-luminal secretions and mucous plugs may represent an important advance in the management of acutely ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting and to prevent relapse after discharge from the ED. OBJECTIVES 2.1 Study Hypothesis: rhDNAse can be safely used in patients presenting to the Emergency Department with acute moderate-severe asthma who do not have adequate responses to beta-agonists Project Specific Aim: This is a pilot study to determine the safety of three different doses of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ED with acute asthma. In addition to safety trends for improvement in pulmonary function and clinical outcomes will be monitored and data analyzed. Based on the safety profile and observable responses to treatment, this information may be used to develop larger trials to determine the efficacy and dosing strategy for treating acutely ill asthmatics with rhDNAse.

Official Title
-----------------
Use of Aerosolized rhDNase (Pulmozyme®) in Emergency Department Adults With Refractory Acute Asthma: A Pilot Study

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

Intervention / Treatment
-----------------
* Drug: rhDNAse (pulmozyme)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute asthma FEV1<60% post-standard care age 18-55 years - Exclusion Criteria: other chronic lung illness pregnancy -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: rhDNAse (pulmozyme)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute disease
A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure

Study Overview
=================
Brief Summary
-----------------
Several epidemiological studies found that exposure to antineoplastic agents were associated with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN), sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially exposed to these agents while cleaning ward, ward toilet or other area. One medical center and one area hospitals in Taipei.Surface wipe samples were collected in the cleaning staff work area, such as ward environment and ward toilet. Urine and blood samples of subjects were collected for exposure examinations. Platinum-containing drugs (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface wipe samples) and biological (urine and blood samples) samples. A self-administered questionnaire was used to collect demographic data, working practices, medical and contact history, and perceived work-related symptoms of cleaning staff. The results of this study will be to reduce exposure to cleaning staff.

Official Title
-----------------
A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure

Conditions
-----------------
Sister-chromatic-exchange(SCE), Micronuclei(MN)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only included those who signed the consent study Exclusion Criteria: none
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 |
| --- | --- |
| Experimental Group<br> | |
| Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleaning staff, antineoplastic agents
The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.

Detailed Description
-----------------
Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.

Official Title
-----------------
Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis

Conditions
-----------------
Meningitis, Cryptococcal, HIV Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis. Patients must have: HIV infection. Acute cryptococcal meningitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure > 95 mm Hg), or symptomatic ischemic heart disease (angina). Orthostatic hypotension, defined as a decrease in systolic blood pressure of >= 20 mm Hg upon standing. Coma. Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response. Opening CSF pressure >= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.) Any concurrent disease that would preclude participation in the study. Patients with the following prior conditions are excluded: History of any bleeding disorder. History of active renal or hepatic disease. Myocardial infarction within the previous 3 months. Stroke within the previous 3 months.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lobradimil|nan|
|Drug: Amphotericin B|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS-Related Opportunistic Infections, Meningitis, Drug Therapy, Combination, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B