linjc16/ctgov huggingface dataset:
High-Volume Vs Low-Volume Preparation in Emergency Department

Study Overview
=================
Brief Summary
-----------------
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS). The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.

Official Title
-----------------
Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy

Conditions
-----------------
GastroIntestinal Bleeding

Intervention / Treatment
-----------------
* Drug: Low volume macrogol
* Drug: High volume macrogol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females > 18 years and <85 years, hemodynamically stable, able to sign informed consent requiring colonoscopy anemia (loss of at least 2 g/dl of Hb) with or without active bleeding Exclusion Criteria: suspected or confirmed pregnancy, hemodynamically unstable patients, patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, heart failure (Class III or IV NYHA), severe liver failure, end-stage renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High-Volume<br>Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy | Drug: High volume macrogol<br>* Selg 4 lt<br>|
| Other: Low-Volume<br>Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy | Drug: Low volume macrogol<br>* Clensia 2 lt<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal cleansing | Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level) | during colonscopy procedure |
Evaluation and Treatment of Heart Disease in Patients Not Participating in Research

Study Overview
=================
Brief Summary
-----------------
There is an important need to maintain clinical skills, provide quality training and expertise, and provide an environment that stimulates ideas for clinical research. This study permits inpatient evaluation and management of patients with heart disease who do not qualify to participate in studies currently being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute.

Detailed Description
-----------------
There is an important need to maintain clinical skills, to ensure adequate training and expertise, and provide an environment that stimulates ideas for clinical research. This protocol permits inpatient evaluation and management of patients with heart disease who do not fulfill criteria for participation in existing Cardiology Branch research protocols.

Official Title
-----------------
Evaluation and Therapy of Heart Disease in Patients Not Participating in Research (Teaching Protocol)

Conditions
-----------------
Arrhythmia, Congenital Heart Defect, Heart Disease

Intervention / Treatment
-----------------
* Behavioral: inpatient evaluation and management


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with signs or symptoms of heart disease. Patients selected because of either medical or research interest to the Principal Investigator. Patients must not have unstable angina pectoris, unstable course following recent (within one month) myocardial infarction. Must not be in New York Heart Association functional class IV heart failure. A positive pregnancy test will obviate any cardiovascular testing requiring ionizing radiation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: inpatient evaluation and management|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
-----------------
Training Protocol, Cardiac Diagnosis, Congenital Heart Disease, Acquired Heart Disease, Arrhythmias
Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

Study Overview
=================
Brief Summary
-----------------
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste

Official Title
-----------------
A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: Tegaserod and Polyethylene Glycol 3350


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged 18 to 64 years of age Patients with constipation as defined by the Rome II criteria Exclusion Criteria: Patients who have been previously been treated with tegaserod and/or PEG 3350 Evidence of cathartic colon or a history of laxative abuse or laxative dependence History of fecal impaction which necessitated surgical intervention Patients with clinically significant abnormal TSH levels at screening Women who are pregnant or breast feeding Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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: Tegaserod and Polyethylene Glycol 3350|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation, Tegaserod, Polyethylene Glycol 3350, PEG
Ispinesib In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.

Official Title
-----------------
A Phase II, Open-Label Study of Ispinesib in Subjects With Locally Advanced or Metastatic Platinum-Refractory or Platinum-Relapsed Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Small-Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Ispinesib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have received only one prior platinum-based chemotherapy regimen. Blood tests will be done to check if blood counts are adequate for taking part in the study. Exclusion Criteria: Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function. Females who are pregnant. Any unstable, pre-existing major medical condition or history of other cancers. Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Overall Response Rate of tumor. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platinum-Refractory, Platinum-Relapsed, Non-Small Cell Lung Cancer
E-cigarettes and Blood Vessel Function

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.

Detailed Description
-----------------
Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

Official Title
-----------------
The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Other: one time exposure to e-cig with nicotine
* Other: one time exposure to e-cig without nicotine
* Other: one time exposure to empty e-cig


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Cardiac disease Respiratory disease Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine<br>Use an e-cig filled with liquid with nicotine | Other: one time exposure to e-cig with nicotine<br>* one time exposure to e-cig vapor with nicotine<br>|
| Experimental: no nicotine<br>Use an e-cig filled with liquid without nicotine | Other: one time exposure to e-cig without nicotine<br>* one time exposure to e-cig without nicotine<br>|
| Sham Comparator: sham comparator<br>Use an empty e-cigarette (sham control) | Other: one time exposure to empty e-cig<br>* one time exposure to empty e-cig (sham control<br>* Other names: sham control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation (FMD) | FMD is a measure of endothelial function | 10 minutes after exposure | 
| Paraoxonse | plasma oxidative stress | less than 1 hour after exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine, endothelial function, oxidative stress
Bone Pain Score Validation Initiative

Study Overview
=================
Brief Summary
-----------------
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.

Detailed Description
-----------------
Aim of this study is to translate the questionnaire and to examine the psychometric properties of BOMET-QoL-10 in a German population. Correlations with the EORTC QLQ-C30/BM22 at the time of enrolment and throughout the study aim to verify that the BOMET-QoL-10 is reliable, valid and able to detect stabilization or changes in quality of life.

Official Title
-----------------
Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany

Conditions
-----------------
Bone Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults patients (≥ 18 years) Diagnosed cancer of the breast, kidney, lung or prostate Bone metastases Estimated life expectancy of at least 6 months Fluent German speaking, reading and writing Informed written consent Exclusion Criteria: Patients without bone metastases Participation in another study involving questionnaires Patients not able to comply with the assessments specified in the protocol

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of characteristics on questionnaire scores | Impact of tumour entity, comorbidity and further parameters on the scores of bone metastasis at baseline | 6 months | 
| Sensitivity of questionnaire | Sensitivity of BOMET-QoL-10 in patients with / without progression of the disease | 6 months | 
| Sequence effects of questionnaires | Influence on the order questionnaires are filled out | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary cancers of the breast, primary cancers of the kidney, primary cancers of the lung, primary cancers of the prostate
The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?

Study Overview
=================
Brief Summary
-----------------
The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.

Official Title
-----------------
The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective? An Analysis Using UK Based Electronic Health Records of 5.6 Million Individuals.

Conditions
-----------------
Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom

Intervention / Treatment
-----------------
* Drug: ACE inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year. Exclusion Criteria: We exclude individuals with a prior history of influenza and viral pneumonia before study entry.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACEI user<br>Individuals with an ACEI prescription in the study population. | Drug: ACE inhibitor<br>* Any prescription of ACE inhibitor<br>|
| Matched controls<br>Individuals without an ACEI prescription, and matched to the users by sex and 10-year age categories. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of influenza |  | Jan 1st 1998 - May 31st 2016 |
Socioeconomic Profile and Patient Satisfaction Assessment

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the socioeconomic patient's profile and their level of satisfaction in the general dental practice clinic. A cross-sectional quantitative study was accomplished with 80 patients assisted at the referred service. A solely-applied questionnaire was used regarding the following aspects: structure and environment, fear and anxiety, reliability, empathy and commitment, resolutivity and quality of the accomplished services. It was observed that the assisted patients' profile consisted predominantly of a female sample (71,2%), that completed the medium learning (31,2%) and/or that didn't finish the fundamental level (26,2%). Moreover 50% of them presented a family income of 1 to 2 minimum salaries and 41,2% were unemployed. As the quality of the rendered technical service, nearly 70% of the users considered it great, as well as the clinic's structure and environment. Regarding the satisfaction with to the received treatment, 76,2% of the interviewees gave the maximum score of 10 and 95% would recommend the attendance to others. It is concluded that the patients are satisfied with the clinical attendance accomplished by the students in the general practice dental clinic at UNIFOR, in what refers to its technical and functional quality.

Official Title
-----------------
Socioeconomic Profile and Patient Satisfaction Assessment in an Academic Dental General Clinic

Conditions
-----------------
Satisfaction, Dentist-Patient Relations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient registered in Academic of Information System (SIA), Patient assisted in the general dental clinic, To have 18 years or more or to be parents accompanied, Agree with research participation. Exclusion Criteria: To be urgency patient, To be the first day of attendance at clinic.

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?
-----------------
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
-----------------
Patient satisfaction, Dentist-Patient relations, Answering services
Quality of Life Following ECMO

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the quality of life of patients in the years following treatment with extracorporeal membrane oxygenation (ECMO). The study population will include all adults treated with any configuration of ECMO at Duke University Medical Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality of life. In addition, patients will be asked to opt-in to participate in a phone survey in which they can give a narrative about their ICU experience and answer specific questions regarding long-term comorbidities. Data will be stored in a secure online server which is HIPAA compliant and analyzed by the department of anesthesiology statistical support services. De-identified data will be shared with the WHO as specified in their usage agreement.

Official Title
-----------------
Assessment of the Long Term Quality of Life Following Veno-venous and Veno-arterial Extracorporeal Membrane Oxygenation (ECMO)

Conditions
-----------------
Extracorporeal Membrane Oxygenation, Quality of Life

Intervention / Treatment
-----------------
* Other: Survey Questions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VA or VV ECMO performed during retrospective study period Exclusion Criteria: Pediatric

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 |
| --- |
|Other: Survey Questions|Subjects will receive surveys via direct mail. They will be given the opportunity to opt in to receive a phone call regarding quality of life.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as Assessed by the WHOQOL-BREF. |  | 6 months to 5 years post ECMO procedure |