linjc16/ctgov huggingface dataset:
Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.

Detailed Description
-----------------
The concentration of cipro will be determined using a validated high-performance liquid chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the HPLC system.

Official Title
-----------------
Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer

Conditions
-----------------
Childhood Cancer, Neutropenia

Intervention / Treatment
-----------------
* Other: Ciprofloxacin administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are between 1 month and 18 years of age are under treatment for any type of childhood cancer use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment have a PAC for intravenous medication and blood draws. Exclusion Criteria: Children will be excluded from this study if we are unable to obtain informed consent of both parents and assent of the child (if he/she is over 12 years of age) aspire blood from the PAC.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 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 |
| --- | --- |
| Other: Ciprofloxacin administration<br>Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw. | Other: Ciprofloxacin administration<br>* Ciprofloxacin will be administered via the PAC directly followed by a NaCl 0.9% flush to wash the PAC. At least 1 hour afterwards 500 microliter of blood will be drawn via the PAC. Directly hereafter a blood draw of 500 microliter will be performed either via capillary blood sampling or via a venipuncture. If an anaesthesia is foreseen for another procedure (e.g. a lumbar puncture or an osseous punction), we will strive to perform the peripheral blood draw under anaesthesia.<br>* Other names: Port A Cath (PAC);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction |  | 1 hour |
Efficacy of Treatment for Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of these questionnaires is to give us an overview of how GAD has affected your life, and perhaps also to give us some clues about things that may have set you up to experience GAD.

Detailed Description
-----------------
For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your generalized anxiety disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your GAD (e.g., depression, intolerance of uncertainty). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Official Title
-----------------
Efficacy of Treatment for Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Generalized Anxiety Disorder, and are accepted for treatment at the clinic. Exclusion Criteria: Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Generalized Anxiety Disorder.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalized Anxiety Disorder, Anxiety, Treatment efficacy
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy

Study Overview
=================
Brief Summary
-----------------
This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III, multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD) (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12). Only patients who participated in ICA-17043-10 are eligible for this open label study

Official Title
-----------------
An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease, Sickle Cell Anemia

Intervention / Treatment
-----------------
* Drug: ICA-17043


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successfully completed Study ICA-17043-10 Discontinued Study 10 or 12 following the DMC recommendations because he/she was not on HU, and has since been on a stable dose of HU for at least 3 months prior to Day 1 Male, or female not capable of becoming pregnant or using appropriate birth control Has willingly given written informed consent to participate in this study Exclusion Criteria: The subject, if female, has a positive urine pregnancy test on Day 1 (before entering study) The subject is presently unsuitable for participation in this long-term study

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 66 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: ICA-17043|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures only |  | at least 60 weeks | 
| No efficacy outcome measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickle cell disease, sickle cell anemia
Efficacy Safety Score in Postoperative Management

Study Overview
=================
Brief Summary
-----------------
The primary aim of this project is to determine whether postoperative patients may benefit from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.

Official Title
-----------------
Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study

Conditions
-----------------
Pain, Postoperative, Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Device: Efficacy Safety Score monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing surgery expectedly to be treated and observed in hospital for more than 24 hours postoperatively Exclusion Criteria: refusal of participation poor communication capabilities

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efficacy Safety Score monitoring<br>Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward | Device: Efficacy Safety Score monitoring<br>* According to data gathered from ESS and monitoring, the patients will receive needed care.<br>* Other names: Isansys, Patient Gateway System;|
| No Intervention: Regular<br>Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Mobilization | The measured postoperative time when patient can stand and able to walk one or more steps, with or without support | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measurement, Verbal Numeric Rating Scale | Reported pain hourly on a 11-digit scale, called Verbal Numeric Rating Scale for pain, 0-10 where 0 is no pain, and 10 is worst thinkable pain. Higher scores mean a worse outcome. | 24 hours | 
| Patient Satisfaction | Reported patient satisfaction on a 1-5 scale, (Likert scale), where 1 is Very dissatisfied, and 5 is Very satisfied. Higher scores mean a better outcome. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient safety, Postoperative care, Monitoring, physiologic, Safety management
Decision Aid for Gastroesophageal Reflux Disease Management

Study Overview
=================
Brief Summary
-----------------
The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on  100 patients who have GERD to assess effectiveness.

Official Title
-----------------
Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease, Esophageal Cancer, Barrett's Esophagus

Intervention / Treatment
-----------------
* Other: Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with GERD, Age at least 18, Able to give consent Exclusion Criteria: Unable to perform decision aid on a computer

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 |
| --- | --- |
| GERD patients<br>Patients who have GERD will be recruited for this study. | Other: Decision Aid<br>* Patients will use a decision aid administered on a computer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant acceptability | Patients will be surveyed after using the intervention to determine if they felt it was useful and whether they would recommend it to others. | Patients will be surveyed on the day of the decision aid (1 day). | 
| Participant Satisfaction | The Patient Satisfaction with Decision Scale will be adapted for this study. This is a six-item scale has been shown to be reliable and valid. | Patients will be surveyed on the day of the decision aid (1 day). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient decisions | Patient intervention choice will be solicited both before and after the decision aid. | Patients will be surveyed on the day of the decision aid (1 day). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Heartburn, Decision Aid
Transition From Pediatric to Adult Cystic Fibrosis Care Center

Study Overview
=================
Brief Summary
-----------------
The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients. This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis. Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).

Official Title
-----------------
Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Transition pediatric - adult


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status. Exclusion Criteria: - Patients whose transition year is not given in the French national register, that is to say patients from some mixed care center.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Transition<br>Patients who switched from pediatric cystic fibrosis care center to an adult cystic fibrosis care center during 2013 or 2014, regardless of their clinical status. | Other: Transition pediatric - adult<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FEV (FEV is the slope expressed in percentage of the predicted value). |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) |  | Two years | 
| Pseudomonas aeruginosa colonization |  | Two years | 
| External pancreatic insufficiency |  | Two years | 
| Diabetes |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transitional care, teenagers, cystic fibrosis, pulmonary function, nutritional function, Patients who experiment a transition pediatric - adult care
Diabetes in the Elderly: Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. Management of hyperglycemia is challenging in the geriatric population in long-term facilities. Numerous factors place hospitalized patients at increased risk for hyperglycemia including aging, sedentary life, stress of medical and surgical comorbidities, and changes in antidiabetic regimen. In addition, elderly patients often experience changes in their nutritional intake and organ dysfunction which increase the risk of hypoglycemic events. There are only a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities. In addition, no randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities.

Detailed Description
-----------------
The investigators will conduct a retrospective study to determine the prevalence of diabetes, comprehensively describe the management of diabetes, and to evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects admitted to two large long-term care facilities: Grady Health System (GHS) and Veterans Administration Medical Center (VAMC) in Atlanta, Georgia between 1/01/08 to 12/31/08.

Official Title
-----------------
Diabetes Care in Nursing Home Residents

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 65+ diagnosis of diabetes

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 |
| --- | --- |
| Nursing home residents with diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of diabetes |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in glycemic control | determine differences in glycemic control as measured by mean daily blood glucose concentration between different insulin regimens | 1 year | 
| evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, elderly, nursing home resident
VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension

Official Title
-----------------
A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Set of supportive tools/measures vs. standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients >= 18 years Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and < 170 and/or diastolic blood pressure ≥ 90 mmHg and < 105 mmHg Exclusion Criteria: Moderate and severe hypertension Pregnant or nursing women A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Set of supportive tools/measures vs. standard care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance and persistence between randomized groups over time. |  |  | 
| To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy |  |  | 
| To assess the relation between drug exposure and BP reduction. |  |  | 
| To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg |  |  | 
| To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus |  |  | 
| HCTZ 12.5 mg. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, valsartan, compliance