linjc16/ctgov huggingface dataset:
Predictive Factors Study

Study Overview
=================
Brief Summary
-----------------
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.

Official Title
-----------------
Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Acromegaly. Males and females aged 18 years and older. Signed informed consent (patient must give consent to the collection of retrospective data). Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study. With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG. If already being treated with ATG: Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable). Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly. Exclusion Criteria: The subject has had radiotherapy in the last 5 years. The subject has had surgery in the last 3 months. The subject has already been included in this study. Participation in an interventional trial, or receiving experimental drug.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acromegalic patients<br>Acromegalic subjects treated with Somatuline Autogel® (Lanreotide) | Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.<br>* Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline |  | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline |  | Baseline, 1 year and 3 years |
Prevalence of Antimicrobial-resistant Pathogens in Patients Admitted for UTIs

Study Overview
=================
Brief Summary
-----------------
Between 2013-2014, our study network of U.S. emergency departments, EMERGEncy ID NET, found that the rate of fluoroquinolone-resistant E. coli was 11.7% among all patients, 6.3% in uncomplicated and 19.9% in complicated. ESBL-producing Enterobacteriaceae were found in 7.7% of all cases, 2.6% in uncomplicated and 12.2% in complicated. More recently, Enterobactericeae and gram-negative non fermenting bacteria have started to show resistance to carbapenems (CREs and CR-NF). Patients hospitalized with UTI and urosepsis represent a higher risk population for infections due to multi-drug resistant bacteria and experience serious adverse outcomes, including death. EMERGEncy ID NET will conduct a study to determine the prevalence of ESBL-producing, CREs and CR-NFs among this high risk population of patients admitted for UTI from U.S. emergency departments.

Official Title
-----------------
Prevalence of Extended Spectrum β-lactamase and Carbapenem-Resistant Gram-Negative Bacteria in Patients With Urinary Tract Infection and Urosepsis Admitted Through Emergency Departments in the United States

Conditions
-----------------
Urosepsis, Urinary Tract Infections

Intervention / Treatment
-----------------
* Other: urine culture and susceptibility testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years; Admitted to the hospital through the ED; Primary reason for admission is treatment of UTI with or without sepsis (i.e., ED diagnosis of UTI and/or sepsis); and Provide verbal or written consent to participate in the study or if patient is unable to provide consent (e.g., altered mental status), consent obtained from a legal authorized representative. Exclusion Criteria: patients will be later excluded if : they are unable to provide a urine specimen for culture; or their urine culture yields no growth or is contaminated (see definition of positive urine culture below). Note: If participant's urine culture is contaminated but their blood culture is positive for a uropathogen, they will not be excluded.

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: urine culture and susceptibility testing|All patients will have a urine culture and susceptibility test ordered per standard care. Results of tests will identify which patients have antimicrobial-resistant organisms.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ESBL-producing Enterobacteriaceae |  | 2 years | 
| Prevalence of carbapenem-resistant Enterobacteriaceae (CRE) |  | 2 years | 
| Prevalence of carbapenem-resistant non fermenting gram negative bacteria |  | 2 years |
Prospective & Retrospective Data Collection of Breast Cancer Cases From 2000 to Present

Study Overview
=================
Brief Summary
-----------------
Prospective & Retrospective data collection of breast cancer cases from 2000 to present

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Breast Cancer database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with breast cancer
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Breast database<br>Database | Other: Breast Cancer database<br>* prospective breast cancer database<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Database |  | 10 years |
PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients

Study Overview
=================
Brief Summary
-----------------
This prospective observational cohort study aims at studying functional and clinical outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order in Northern Italy during an index period of 4 months. Other areas assessed include variables that help or hinder the discharge of patients with sufficient residential autonomy and the predictive ability of clinicians compared with the evaluation of selective indicators of outcome (clinical and instrumental). Patients are followed from the first day of hospitalization until discharge or up to 3 months and 1 day after the date of admission (long-term care patients). At admission a Patient Form including social, demographic and clinical informations and a series of standardized assessment tools is completed with the help of clinicians, nurses and caregivers (when available). For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is performed and adverse events occurred during hospitalization are monitored, as well as the predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at discharge (or after 3 months for long-term care patients) and at 6 months follow-up of with a standardized telephone interview to assess clinical and functional status and possible changes in the residential status of the patient.

Official Title
-----------------
THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY.

Conditions
-----------------
Dementia, Motor Impairments, Stroke, Thighbone Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 65 or older informed consent provided Exclusion Criteria: younger than 65 years informed consent not provided

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Hospitalized patients<br>All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of clinical improvement |  | from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of variables predictive of outcomes |  | at discharge (or 3 months after admission) and 6 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive impairment., Geriatrics., Hospital admission., Hospital discharge.
Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15.

Detailed Description
-----------------
Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15. During Cycle 1 participants will be required to spend the evening before Day 1 in the General Clinical Research Center and frequent blood samples will be drawn on Day 1; this schedule will be repeated the evening of Day 6 with the blood samples drawn on Day 7. Participants will have weekly CBCs.

Official Title
-----------------
A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies

Conditions
-----------------
Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Age 18 and older Histologic proof of cancer that is unresectable ANC greater than 1500 u/L PLC greater than 100,000 u/L Total bilirubin less then or equal to ULN AST less than 3 x ULN or AST less than 5 x ULN if liver involvement Creatinine less than 1.5 x ULN Hemoglobin greater than 9 g/dL Echocardiogram with ejection fraction great than 40% Life expectancy of more than 12 weeks

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: Topotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| find the highest dose of GW572016 and Topotecan that can be safely given together |  |  | 
| Learn the side effects of GW572016 and Topotecan when given together |  |  | 
| Learn whether GW572016 changes how the body handles or processesTopotecan |  |  | 
| Learn whether Topotecan changes how the body handles or processes GW572016 |  |  |
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.

Official Title
-----------------
Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.

Conditions
-----------------
Acne Scars

Intervention / Treatment
-----------------
* Drug: Adapalene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects of any race, aged 18 to 50 years inclusive Subjects with a past history of acne and with moderate to severe facial atrophic acne scars Exclusion Criteria: Subjects with active inflammatory acne lesions Subjects with hypertrophic acne scars

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Differin 0.3%<br>Differin® 0.3% Gel Adapalene 0.3% Topical to the face, once daily application in the evening for the first four weeks and twice daily application in the morning and in the evening for the following 20 weeks. | Drug: Adapalene<br>* Adapalene Gel 0.3%<br>* Other names: Differin 0.3%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Scarring Severity | Grade Level: Macular disease Mild disease Moderate disease Severe disease | Week 24 |
OCS Liver DCD Trial

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Detailed Description
-----------------
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Official Title
-----------------
Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Device: OCS Liver System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered primary liver transplant candidate Age ≥ 18 years Obtained informed consent Exclusion Criteria: Acute, fulminant liver failure Prior solid organ or bone marrow transplant Ventilator dependent on day of transplant/donor organ offer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS Preserved Livers<br>This is a single-arm trial of OCS preserved livers used for transplantation. | Device: OCS Liver System<br>* The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver graft survival through 6 months post-transplant | Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of donor liver utilization after OCS liver perfusion | The number of eligible donor livers that were instrumented and perfused on OCS liver system and successfully transplanted, divided by the number of eligible donor livers that were instrumented and perfused on OCS | OCS liver perfusion | 
| Incidence of ischemic biliary cholangiopathy at 6 months post-transplant | Evaluation of ischemic biliary complications | 6 months | 
| Incidence of Early Allograft Dysfunction (EAD) or primary non-function | Evaluation of EAD via AST, Bilirubin and INR | 7 days |
Swiss Longitudinal Cohort

Study Overview
=================
Brief Summary
-----------------
The planned research project is a prospective population-based cohort study, similar to the well-known Framingham study in the United States. So far, there is no similar research project in Switzerland. It is planned to examine of three Swiss municipalities. Recruitment in a first Swiss municipality (Lostallo/Cama GR) started 2014 and ended in 2019. Overall, 496 participants were recruited in this municipality. The five-year follow-up in this municipality started in 2019. It is planned to start recruitment in a second Swiss municipality (Uznach SG) in 2020. The examinations embrace a broad spectrum of measurements (for details the investigators refer to the published study protocol).

Official Title
-----------------
Swiss Longitudinal Cohort

Conditions
-----------------
Cardiovascular Risk Factors

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Cama GR, Lostallo GR, or Uznach SG Age ≥6 years (no upper age limit), for voluntary blood sample ≥18 years Willing to participate in long-term study Written informed consent (in participants ≥6 years and <18 years signed by parents) Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | Cardiovascular events (i.e. stroke, myocardial infarction) will be assessed using questionnaires and case records. | 10 years | 
| Heart function | Heart function will be assessed using questionnaires for symptoms, clinical examination and measurement of electromechanical activation time. | 10 years | 
| Cognitive function | Cognitive function will be assessed using validated instruments. | 10 years | 
| Kidney function | Kidney function will be assessed using laboratory measurements. | 10 years | 
| Autonomy | Autonomy wil be assessed using validated instruments. | 10 years | 
| Nursing home admission | Nursing home admissions will be assessed using standardized questions. | 10 years |
MR Scanning of Very Young Children With Severe Developmental Disorders

Study Overview
=================
Brief Summary
-----------------
The specific is to study the MR morphologic and spectroscopic brain correlates and predictors of development in children with severe developmental disorders (autistic spectrum disorders and/or mental retardation and/or language disorders). Given the frequently observed association of autism with known medical conditions, particularly in cases with comorbid mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995), children with suspected autism or related developmental disorders will be asked to participate in an extensive state of the art laboratory work-up which includes T1 and T2 weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal abnormalities and degree of myelination, and quantitatively, measuring volumes of total brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data set provides the opportunity to chart brain-behavior relationships in young children with suspected autism and related PDD cross-sectionally.

Official Title
-----------------
MR Scanning of Very Young Children With Severe Developmental Disorders (Autistic Spectrum Disorders and/or Mental Retardation and/or Language Disorders)

Conditions
-----------------
Autism, Mental Retardation, Language Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 months to 7 years Diagnosis of autism spectrum disorder, a language disorder or mental retardation Exclusion Criteria: Significant motor or sensory impairment Major physical abnormalities History of serious head injury Identifiable neurologic disorder Metal implants Contraindication for MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 7 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
-----------------
Autism, MRI, Developmental Disorders