linjc16/ctgov huggingface dataset:
Hand Hygiene Intervention Study in Finnish Garrison

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. In addition, the investigators will find out the causative agents of infections in a garrison with virological analyses of naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to infectious diseases will be evaluated with a cost analysis study.

Official Title
-----------------
Can Intensified Hand Hygiene Decrease Morbidity and Lost Service Days in a Garrison

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Behavioral: Hand washing with soap and water
* Behavioral: Hand cleaning with alcohol-containing hand rub
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willingness to attend to the study Exclusion Criteria: skin diseases which prevent using hand disinfectants
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arm 2<br>Hand washing with soap and water according to instructions. The effect of intervention is assessed by following occurrence of infections. | Behavioral: Hand washing with soap and water<br>* Can infections be prevented by hand washing with soap and water<br>|
| Placebo Comparator: arm 0<br>No specific advice on hand hygiene. The effect of intervention is assessed by following occurrence of infections. | Behavioral: Control<br> <br> |
| Active Comparator: Arm 3<br>Hand cleaning with alcohol-containing hand rub | Behavioral: Hand cleaning with alcohol-containing hand rub<br>* Can infections be prevented by hand cleaning with alcohol-containing hand rub. Effect of intervention is assessed by following occurrence of infections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infection episodes during basic training period. The periods when a person has been in duty in spite of the infection will be included. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of distinct infection episodes due to infectious disease |  | 8 weeks | 
| Length of distinct absence episodes due to infectious disease. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand Hygiene, Communicable Diseases, Prevention
A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.

Official Title
-----------------
A Phase 1, Placebo-Controlled, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-05180999 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: PF-05180999
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female of non-childbearing potential, Exclusion Criteria: Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-05180999<br> | Drug: PF-05180999<br>* Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo oral solution or capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite (or profile) of Pharmacokinetics |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PF 05180999, safety, pharmacokinetics
Ritanserin in Treatment of Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.

Official Title
-----------------
Ritanserin in Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Ritanserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 47 Years

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

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: Ritanserin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine use |  |  | 
| Cocaine craving |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Dependence, ritanserin
Pain and Stress Assessment and ROP Screening

Study Overview
=================
Brief Summary
-----------------
The study will measure the effects of eye exams on markers of stress in the urine. In addition, measurements will be taken to show the effects of stress on brain activity, O2 sats, and blood flow.

Official Title
-----------------
Pain and Stress Assessment and ROP Screening Examination in Premature Infants

Conditions
-----------------
Pain, Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants between 24 -32 weeks of gestational age Exclusion Criteria: Infants scheduled for laser eye surgery on the day of the examination Infants with intraventricular hemorrhage ≥ grade 3 (Papile classification) diagnosed by head ultrasound Infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam Renal injury defined with plasma creatinine > 1.5 mg/dL Severe cyanotic congenital heart disease Unstable respiratory distress (hypoxemia PaO2 < 50 mm Hg or SpO2 < 90%)

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

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 |
| --- | --- | --- |
| Urine Stress Marker | Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aEEG | 1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam. | 24 hours | 
| NIRS | 1 hour prior to the eye exam and will be kept in place until 24 hours after the end of the eye exam | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain and stress assessment in premature infants
Knowledge and Perception of Clinical Trial Participation in Breast Cancer Patients in Egypt

Study Overview
=================
Brief Summary
-----------------
Clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. Beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation. This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries.

Official Title
-----------------
Knowledge and Perception of Clinical Trial Participation in Breast Cancer Female Patients in Egypt, a Cross Sectional Study

Conditions
-----------------
Breast Cancer, Clinical Trials

Intervention / Treatment
-----------------
* Behavioral: Knowledge and perception of clinical trial participation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female breast cancer patients Exclusion Criteria: Patients who refuse participation

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Knowledge and perception of clinical trial participation|This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of breast cancer patients who accept to participate in clinical trials |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The barriers for participation in clinical trials |  | 1 year |
Chronic Pain Management After Herniorraphy

Study Overview
=================
Brief Summary
-----------------
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.

Official Title
-----------------
Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: pregabalin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of unilateral inguinal herniotomy Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area Duration pain ≥ 3 months Medial or lateral inguinal hernia Age ≥ 18 years VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today' Grade III or IV pain and discomfort on the 4-point pain and discomfort scale Informed consent (addendum V) Exclusion Criteria: Participation in another trial Age < 18 years Cognitive disfunction Patient is unable to speak Dutch Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption Patient classified as American Society of Anaesthesiologist Class 4 Renal impairment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo drug during 8 weeks<br>|
| Active Comparator: pregabalin<br> | Drug: pregabalin<br>* pregabalin 150-600mg/day during 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative sensory testing (QST) accuracy in testing the inguinal region |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal, hernia, chronic, pain, pregabalin, chronic pain after inguinal herniorraphy
A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit rate.

Official Title
-----------------
A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Procedure: adherence intervention
* Procedure: intervention without adherence advice
* Procedure: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male ethnic Chinese aged 18 or above Smokes at least 1 cigarette per day Is not following other forms of smoking cessation interventions Intends to quit smoking within the next 7 days of the first contact and would use NRT Free from illness that contraindicate to the use of NRT Has signed an informed consent form, or has given verbal consent (for those contacted by telephone) Exclusion Criteria: Patients who are psychologically or physically unable to communicate Children and teenagers (aged below 18) Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adherence intervention|nan|
|Procedure: intervention without adherence advice|nan|
|Procedure: control|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quit rate |  | 6-month | 
| adherence rate |  | 4-weeks after the first use of NRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erectile function |  | 6-month | 
| use of NRT |  | 3-month | 
| quit rate |  | 3-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation
Prosthetics Registry and Outcomes in Urology at Duke

Study Overview
=================
Brief Summary
-----------------
To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. The study team will collect retrospective data from subjects at Duke University and Duke Raleigh Hospitals who have undergone genitourinary prosthesis implantation from January 1, 1996 onward. Prospective data will only be collected from patients seeking care with Dr. Lentz in Duke Raleigh.

Official Title
-----------------
Prosthetics Registry and Outcomes in Urology at Duke

Conditions
-----------------
Penile Implantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Adult (18 years of age or older) Inflatable or semi-rigid penile prosthesis placed Exclusion Criteria: - Inability to provide informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with penile prostheses<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of data repository to capture longitudinal outcomes and satisfaction for subjects who receive penile prostheses. |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, erectile dysfunction, penile prosthesis
Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to collect anatomical data in an ambulatory healthy population to aid in the development of a novel non-invasive technology to assess changes in lung hydration status. It will also help in developing reference ranges of lung hydration status in healthy subjects and their associated changes with time.

Official Title
-----------------
Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology

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

Intervention / Treatment
-----------------
* Device: IMED-4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects > 30 years of age Subjects who are ambulatory not requiring assistance for ambulation Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB Exclusion Criteria: Subjects with an active implantable medical device not cleared for use with the IMED-4 in the IMED- 4 Investigators Brochure. Subjects who are pregnant or lactating or who have been pregnant within the past three months Subjects who have a measured temperature of >38° C at the time of screening Subjects who have tattoos and/or non-intact skin on the back in the electrode patch placement region Subjects who have had a past serious allergic reaction to adhesives Patients who decline to have their backs photographed with the IMED-4 device in position Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectance, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Subjects without heart failure<br> | Device: IMED-4<br>* Non-invasive novel lung hydration status sensor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection | The primary endpoint is successful IMED-4 recordings at multiple timepoints from one hundred (100) unique subjects. A recording will be considered successful if it meets IMED-4 recording quality indicators. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHF, Heart Failure
Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection

Study Overview
=================
Brief Summary
-----------------
The aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. The investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.

Official Title
-----------------
Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection

Conditions
-----------------
Disorder of Transplanted Kidney, Cytomegalovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with BMI below 30, first transplants with PRA < 30, no contraindication for induction Thymoglobuline, age 18 years or younger than 70 years. Exclusion Criteria: patients with a BMI above 30 retransplantation patients hypersensitized with PRA > 30 compared with Thymoglobulina indication for induction age under 18 or over 70 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Tacrolimus, Everolimus<br>Immunosuppression is the same for all patients in the study until the period between the 3rd and 5th weeks, when patients will be randomized to initial regimen and remain or be converted to everolimus tacrolimus. | |

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
-----------------
Immunosuppression, Cytomegalovirus, Renal Transplant, Atrophy/interstitial, Conversion of tacrolimus everolimus