linjc16/ctgov huggingface dataset:
Expanding Antimicrobial Stewardship

Study Overview
=================
Brief Summary
-----------------
Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This research study involves data collection from enrolled subjects and treating physicians. The data will be collected using a patient interview which will be answered directly by the patient or caregiver. Additional surveys will be administered to the Emergency Department treating physician and subsequent physician. Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department. A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.

Official Title
-----------------
Expanding Antimicrobial Stewardship

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years of age Exclusion Criteria: Patient incarcerated Chief complaint of suicidal or homicidal ideation Patient primarily evaluated by the trauma team

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Older Adults<br>Adults 65 years and older who present to the Emergency Department. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of infection while in the Emergency Department |  | participants will be followed for the duration of hospital stay, an expected average of 4 days. |
Prevalence of Hypogonadism in Male Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Cancer and its complications are common problems. In most cases, this condition has a profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. However, these symptoms also are seen in men with other conditions including those with low testosterone levels. The objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.

Official Title
-----------------
Prevalence of Hypogonadism in Male Cancer Patients

Conditions
-----------------
Cancer, Hypogonadism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects ≥ 18 years of age with histological diagnosis of cancer for cancer group. Provide written informed consent prior to screening. Histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups. Exclusion Criteria: Concomitant use of GH, Megestrol, Marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study. Participation in a clinical trial with investigational agents within 1 month of enrollment. Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).

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

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

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
-----------------
Cancer, Hypogonadism, testosterone, cachexia
Boom-IBD Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Feasibility study of neuromodulation in patients with IBD.

Detailed Description
-----------------
The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Official Title
-----------------
Boom-IBD Clinical Trial

Conditions
-----------------
IBD

Intervention / Treatment
-----------------
* Device: Neuromodulation


Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: Male or female 18 to 75 years of age Diagnosed with Crohn's Disease or ulcerative colitis Ability and willingness to consent to participate by signing the informed consent form Ability to comply with the protocol and willingness to comply with all follow-up requirements Still have part or all of their colon General Exclusion Criteria (The subject must not meet ANY of the following criteria): Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study Any psychiatric or personality disorder at the discretion of the study investigator Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess) Active clostridium difficile infection of the colon Active cytomegalovirus (CMV) infection of the colon Evidence of colonic perforation Fulminant colitis requiring emergency surgery Microscopic, ischemic or infectious colitis Unresected neoplasia of the colon Colonic stricture unable to pass a colonoscope History of cancer including melanoma (except for localized skin cancers) within 2 years Participation in another clinical trial within the past 30 days of device implant Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant Inability to operate the patient programmer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Treated<br>Patients implanted with neuromodulation | Device: Neuromodulation<br>* Neuromodulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Index | CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis) | up to 1 year |
Pulmonary Disease in a Psychiatric Inpatient Population

Study Overview
=================
Brief Summary
-----------------
Purpose: Patients with mental health disorders have a reduced life expectancy, compared to the general population. The shorter life expectancy is caused by natural and unnatural death. In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the general population, characterized by e.g. lack of exercise and smoking. Hypothesis Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients There is a higher prevalence of COPD in psychiatric inpatients compared to the general population Screening of patients with one respiratory symptom and a smoking history, has the same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking history Method: 80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will be taken into account.

Official Title
-----------------
Pulmonary Disease in a Psychiatric Inpatient Population, a Screening Study

Conditions
-----------------
Chronic Obstructive Airway Disease

Intervention / Treatment
-----------------
* Procedure: Spirometry with reversibility test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6 Admission time over 48 hours Exclusion Criteria: Patients who is not able to perform spirometry due to their psychiatric condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spirometry with reversibility test<br>Spirometry with reversibility test | Procedure: Spirometry with reversibility test<br>* Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration<br>* Other names: MicroLoop handheld transportable spirometer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tiffeneau index | - FEV1/FVC ratio | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced vital capacity | FVC L/s | at enrollment | 
| Forced expiratory volume in 1 second | FEV1 L | at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Psychiatric inpatient, Smoking
Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

Study Overview
=================
Brief Summary
-----------------
The rationale of the study is to clarify whether the supplementation of irbesartan with ciprofibrate could increase the antihypertensive effect, could improve the endothelial functions, and/or could affect the atherogenic small-dense LDL-, oxydized LDL concentrations, onto the paraoxinase activity and on the CRP and insulin levels.

Official Title
-----------------
Investigations of the Effects of Aprovel, Lipanor and Their Combination Onto the Endothelial Functions of Dyslipidemic Patients Measure by Laser Doppler Flow-Metry.

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Irbesartan
* Drug: Ciprofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertensive + dyslipidemic + damaged endothelial function Exclusion Criteria: hepatic and kidney damage, IDDM (Insulin Dependent Diabetes Mellitus) Freckson V type hyperlipoproteinaemia 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: 45 Years
Maximum Age: 70 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: Irbesartan|nan|
|Drug: Ciprofibrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular reactivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of target blood pressure |  |  | 
| Measurements of safety laboratory parameters |  |  |
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère

Study Overview
=================
Brief Summary
-----------------
Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.

Official Title
-----------------
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère

Conditions
-----------------
Duchenne or Severe Becker Myopathy

Intervention / Treatment
-----------------
* Device: Magnetic Resonance Cardiac Imaging (with Gadolinium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dystophinopathy (Duchenne or severe Becker) >8yo with social insurance informed consent Exclusion Criteria: arythmia impossibility to undergo an MRI (pacemaker, ....)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Resonance Cardiac Imaging (with Gadolinium)<br> | Device: Magnetic Resonance Cardiac Imaging (with Gadolinium)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exams correctly acquired (feasabiliy of the exam) | Was it possible to acquire the whole examination for every patient ? | after the last inclusion | 
| Number of exams allowing a qualitative assessment of images by the physician | The image quality allows a qualitative diagnosis ? | after the last MRI exam | 
| Number of exams allowing a quantitative assessment of the diagnosis | Did the image quality allow a quantitative assessment of the diagnosis ? | after the last MRI examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS) | correlation between fibrosis information (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS) | after the last inclusion | 
| Number of cardiac segments with fibrosis and/or regional dysfunction | Correlation between fibrosis and regional function for each cardiac segment | after the last inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, free-breathing acquisitions, myopathy, fibrosis assessment, function
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included

Official Title
-----------------
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: sirolimus, mycophenolat mofetil, fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal transplant patients (18 - 65 years, inclusive) cadaver and living renal transplants(1. Ntx, 2. Ntx) Immunsuppression: sirolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months writen informt consent by the patient Exclusion Criteria: contraindications for statins pregnancy or lactating elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: sirolimus, mycophenolat mofetil, fluvastatin|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
-----------------
fluvastain, sirolimus, mycophenolat mofetil, renal transplantation
of Caregiver Family Members for the Disabled in Bukhara

Study Overview
=================
Brief Summary
-----------------
The responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. Therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child.

Detailed Description
-----------------
In the study, family members living in Bukhara, Uzbekistan, and caring for a disabled person under the age of 24 were evaluated. Caregiver burden was evaluated with the Caregiver Burden Scale and healthy lifestyle behaviors were evaluated with the Healthy Lifestyle Behaviors Scale II. The fact that there is no earlier study on caregivers of disabled people in Uzbekistan and no research in the literature examining the relationship between caregiving burden and healthy lifestyle behaviors in individuals with disabled children, make this study unique.

Official Title
-----------------
Relationship Between Burdens and Healthy Lifestyle Behaviors of Caregiver Family Members for the Disabled in Bukhara

Conditions
-----------------
Caregiver Burden

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteering to participate in the study Having a disabled child to take care of Being literate Exclusion Criteria: The age of the disabled person being cared for is over 24 years old.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Caregiver burden and healthy lifestyle behaviors were evaluated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographic information | Age, height, body weight, employment status, income status, marital status | Two months | 
| Number of child | Number of healthy and disabled children | Two months | 
| Assessment of the child age | Age | Two months | 
| Assessment of the child | Gender | Two months | 
| Caregiver Burden Scale | The scale has a Likert-type rating ranging from 0 to 4 as never, rarely, sometimes, quite often, almost always. A minimum of 0 and a maximum of 88 points can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high score indicates a high level of distress. | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Lifestyle Behaviors Scale II | The scale is scored as never (1)-regularly (4). The lowest score for the whole scale is 52 and the highest score is 208. The high scores obtained from the scale indicate how high the individual applies the specified health behaviors. | Two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
handicapped, caregiver burden, healthy lifestyle
Lipoprotein Metabolism in Hypertensive African-Americans

Study Overview
=================
Brief Summary
-----------------
To study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in African American males and females. The study was part of a Collaborative Project on Minority Health which investigated the mechanisms by which insulin contributes to cardiovascular disease.

Detailed Description
-----------------
BACKGROUND: The study was part of the initiative Collaborative Projects (R01s) on Minority Health. The concept for the initiative was developed by the NHLBI staff after the 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The initiative was approved at the September 1992 National Heart, Lung, and Blood Advisory Council and released in October 1992. Julian Marsh was one of three investigators in a collaborative program with Bonita Falkner as Program Coordinator. DESIGN NARRATIVE: In a sub-set of subjects with either high or low plasma insulin levels after a glucose challenge (insulin sensitive or insulin resistant), the investigators determined the fractional and absolute synthesis and catabolic rates of apolipoproteins B and A-I, the dominant lipoproteins of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL). They used stable isotopes and multicompartmental kinetic analysis following an oral bolus dose of deuteroleucine. They hypothesized that in hypertensive African Americans with hyperinsulinemia, more of the smaller Very Low Density (VLDL) particles are secreted and converted to LDL. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hyperinsulinism, Hypertension, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |