linjc16/ctgov huggingface dataset:
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in high flux hemodialysis.

Official Title
-----------------
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Other: pharmacokinetic monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days. Eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers. Written informed consent in a form approved by Northwestern Memorial Hospital, Northwestern University Institutional Review Board, and Midwestern University Institutional Review Board will be completed by the patient prior to enrollment. Exclusion Criteria: Patients that only receive one dose of ceftazidime in total Patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2). Not meeting inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ceftazidime<br>pharmacokinetic monitoring | Other: pharmacokinetic monitoring<br>* pharmacokinetic monitoring<br>* Other names: Fortaz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine clearance of ceftazidime in hemodialysis | Serial blood draws will be performed at the following times in hours (time 0 = end of infusion): the time immediately before hemodialysis, 0.5, 4, and immediately before the next dose of ceftazidime. Any extra blood from samples drawn by the primary provider per routine care during the study period will also be considered for capture if it would routinely be discarded. The blood draws for this study will occur over a period of 72 hours (i.e. until the day of the following hemodialysis session). | time 0 = end of infusion) up to 72 hours |
Educational Program Through Video Conference for Inhaled Therapies in Cystic Fibrosis Patients

Study Overview
=================
Brief Summary
-----------------
Educational programs are essential for cystic fibrosis patients who need to take several different drugs every day. Compliance is often klow in these patients, and clinicals and paramedics try to increase it, through educational programs. As for inhaled therapies, the CF center of Montpellier uses a video conference tool to educate patients. The program may involve either the physiotherapist or the doctor or both. Through the present study, the investigators would like to evaluate the current practice at the CF center of Montpellier and verify if patients feel that the physiotherapist could handle the program on his own, without the support of a physician.

Official Title
-----------------
Evaluation of the Efficacy of an Educational Program Through Video Conference

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: CF patients patient regularly assessed at the CF center of Montpellier major patients patients who recently enrolled a video conference educational program or who will soon be part of it Exclusion criteria: patients not able to participate to a video conference educational program, due to lack of tools at their home

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 |
| --- | --- | --- |
| acceptability of the therapeutic education program by videoconference | acceptability of the therapeutic education program by videoconference with a satisfaction questionnaire | 1 day | 
| need for the presence of the referring physician in relation to a session of therapeutic education carried out by the physiotherapist alone | need for the presence of the referring physician in relation to a session of therapeutic education carried out by the physiotherapist alone with a satisfaction questionnaire | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inhaled therapy, physiotherapist, educational program
Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers

Study Overview
=================
Brief Summary
-----------------
Investigation of arginine and NO metabolism in healthy subjects is important as a reference for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the changes during aging and gender-related differences. Although data on arginine metabolism exist in literature, data are limited to young healthy male subjects. Since patients with suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly and also women, knowledge of arginine metabolism in these groups is needed.

Official Title
-----------------
Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers

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

Intervention / Treatment
-----------------
* Other: stable isotope infusion for measurement of metabolism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age 18-25 years (young); 50-70 years (middle aged/elderly) Exclusion Criteria: Diabetes mellitus type I Livercirrhosis, pancreatitis, malignancies Hypertension (diastolic blood pressure >95 mmHg or systolic blood pressure >160 mmHg) History of gastrointestinal complaints Recent involuntary weight loss (more than 10 % in 6 months or more than 5 % in one month) Pregnancy (pregnancy test is done in female subjects) Use of medication that can affect arginine metabolism (nitrovasodilators and corticosteroids) Subjects with high activity level

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stable isotopes<br>stable isotope infusion for measurement of metabolism | Other: stable isotope infusion for measurement of metabolism<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body NO synthesis | postabsorptive nitric oxide synthesis measured by using stable isotope methodology | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body protein metabolism | postabsorptive whole body protein metabolism (protein synthesis, breakdown, net protein breakdown) measured by using stable isotope methodology | 2 hours | 
| whole body arginine metabolism | postabsorptive arginine metabolism measured by using stable isotope methodology | 2 hours | 
| blood parameters | postabsorptive blood levels (glucose, insulin, urea, amino acids, CRP) | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia

Study Overview
=================
Brief Summary
-----------------
Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm environment. In this study, the effects of physical exercise are investigated in boys and male adolescents with X-chromosomally inherited HED as well as age-matched controls, who undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and 30°C. Body core temperature during and after ergometry, heart rate, performance, and serum lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show an endangering rise of body temperature in connection with physical exercise. To clarify, whether novel cooling devices may reduce the likelihood of overheating, the effects of such devices are evaluated at 30°C.

Official Title
-----------------
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia (Christ-Siemens-Touraine Syndrome)

Conditions
-----------------
X-Linked Hypohidrotic Ectodermal Dysplasia, Exercise-induced Rise of Body Temperature

Intervention / Treatment
-----------------
* Device: Skin cooling devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for patients: hypohidrotic ectodermal dysplasia caused by EDA gene mutations regular fluid intake prior to the investigation written informed consent Exclusion Criteria: acute febrile illness acute or chronic heart disease arterial hypertension gastrointestinal disorders implantable electronic devices MRI investigation scheduled for the 5 days subsequent to the study clinical signs or diagnostic findings of dehydration

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HED children<br> | |
| HED adolescents<br> | Device: Skin cooling devices<br>* Cooling vest and cooling bandana<br>* Other names: Cooline;|
| Control children<br> | |
| Control adolescents<br> | Device: Skin cooling devices<br>* Cooling vest and cooling bandana<br>* Other names: Cooline;|

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
-----------------
hypohidrotic ectodermal dysplasia, exertional hyperthermia, cooling device
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease

Study Overview
=================
Brief Summary
-----------------
rheumatic heart disease remains the majority valvular disease in low and middle income countries, which mostly affected mitral valve, surgical treatment is the most effective strategy to improve the outcomes of middle or late-stage RHD patient, however, whether mitral valve repair surgery is superior to replacement or other evolving interventional device remains controversial, this study aims to investigate the results of repair surgery compared with replacement or other treatment strategy from international multicenters.

Official Title
-----------------
Multicenter Results of Mitral Valve Surgery in Patients With Rheumatic Heart Disease

Conditions
-----------------
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease

Intervention / Treatment
-----------------
* Device: mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1、rheumatic heart disease 2、mitral valve disease 3、combined with other heart valve disease(aortic valve, tricuspid valve, pulmonary valve) 4、patients underwent initial mitral valve surgery or intervention Exclusion Criteria: 1、congenital heart disease degenerative heart valve disease 2、isolated aortic valve or tricuspid valve, pulmonary valve disease( doesn't affect mitral valve ) 3、patients received more than 1 time mitral valve operation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: mitral valve repair|different repair techniques to construct rheumatic mitral valve lesion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | death from any cause | 2011-2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumtic heart disease, mitral valve surgery
Gabapentin to Reduce Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
The intrathecal administration of morphine is gaining popularity. It is easy to do and can reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and vomiting more than other methods providing postoperative analgesia. Patients suffering from these side effects have to spend a longer period of time recovering in the hospital with high cost of medical treatment.

Detailed Description
-----------------
Objective: to study the efficacy of oral administrating of gabapentin 600 mg before surgery to reduce the postoperative nausea and vomiting in patients receiving intrathecal morphine. Methods: Eighty patients undergoing orthopedic surgery and receiving intrathecal morphine will be randomized into 2 groups. The first group will receive oral gabapentin 600 mg and the second group will receive a placebo tablet. Both groups will receive a standard prophylactic medication for postoperative nausea and vomiting. The degrees of nausea and vomiting in both groups will be assessed over 24 hours postoperatively.

Official Title
-----------------
Gabapentin Premedication to Reduce Postoperative Nausea and Vomiting in Surgical Patient Receiving Spinal Morphine

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing general or regional anesthesia receiving spinal morphine ASA physical status I-III Exclusion Criteria: Patients with allergy to morphine or gabapentin Chronic use of narcotics Psychotic Bleeding disorder Cardiovascular disorder Liver or renal failure Pregnancy or breast feeding Neurologic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Patient receiving oral gabapentin 600 mg preoperatively | Drug: Gabapentin<br>* Single oral dose<br>* Other names: Neurontin;|
| Placebo Comparator: Placebo<br>Patient receiving oral placebo tablet preoperatively | Drug: Placebo<br>* Single oral dose<br>* Other names: Sugar pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (grade 1-3) | PONV grading: 0 = none; 1 = mild; 2 = moderate; 3 = severe | through study completion, an average of 24 hours |
Ex-vivo Effect of New Oral Anticoagulants on Point-of-care Devices

Study Overview
=================
Brief Summary
-----------------
Concentration determinations of anticoagulants require plasma instead of whole blood, and results are not immediately available to clinicians. Monitoring anticoagulants concentration along with bedside methods may provide an alternative guide for administration of the NOAC. The purpose of this investigation is to compare bedside coagulation assays in whole blood with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with therapeutic dosis of NOAC.

Detailed Description
-----------------
This open-label study will be performed by ex vivo investigations. Patients receiving the NOAC as dabigatran or rivaroxaban in therapeutic doses are recruited and informed consent of two blood sampling times will be obtained in correlation to the time of drug intake (two and 24 hours after drug intake). The bedside measurements will be performed and compared directly with the concentrations determined by plasma concentration assays. These investigations will be performed at the department of Angiology at the university hospital Frankfurt.

Official Title
-----------------
Time-dependent ex Vivo Influence of Rivaroxaban on Point-of-care Devices

Conditions
-----------------
Effect of NOAC on POCT

Participation Criteria
=================
Eligibility Criteria
-----------------
The indication for the use of NOAC is provided by the attending physician. The criteria for inclusion and exclusion criteria for the use of the new oral anticoagulants must meet appropriate eligibility criteria and the clinical guidelines that are described in the SOPs. Patients treated with dabigatran 2x150mg / d for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation are included. Moreover, patients treated with rivaroxaban 20 mg / d for DVT prophylaxis and treatment of recurrent DVT or PE are included.

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 |
| --- | --- |
| Control<br>Healthy volunteers without medication | |
| Phenprocoumon<br>Patients receiving Marcumar having target INR 2-3 | |
| Dabigatran<br>Patients receiving therapeutic dosis of Pradaxa | |
| Rivaroxaban<br>Patients receiving therapeutic dosis of Xarelto | |

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
-----------------
Dabigatran, Rivaroxaban, Point of Care-testing
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.

Official Title
-----------------
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
-----------------
Coronary Stenosis, Atherosclerosis, Coronary

Intervention / Treatment
-----------------
* Procedure: Rotational atherectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 19 years old Patients who received rotational atherectomy The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: Life expectancy <1y

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Coronary disease<br> | Procedure: Rotational atherectomy<br>* Percutaneous coronary intervention with rotational atherectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF) | Target vessel failure (TVF) composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target Vessel Revascularization (TVR) at 12 months after the procedure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death |  | 1-,6-, and 12-months, and 3-,5-years | 
| Cardiac death |  | 1-,6-, and 12-months, and 3-,5-years | 
| Myocardial infarction |  | 1-,6-, and 12-months, and 3-,5-years | 
| Composite of death or myocardial infarction |  | 1-,6-, and 12-months, and 3-,5-years | 
| Composite of cardiac death or myocardial infarction |  | 1-,6-, and 12-months, and 3-,5-years | 
| Target-lesion revascularization (TLR) |  | 1-,6-, and 12-months, and 3-,5-years | 
| Target-vessel revascularization (TVR) |  | 1-,6-, and 12-months, and 3-,5-years | 
| Stent thrombosis | according to Academic Research Consortium (ARC) criteria | 1-,6-, and 12-months, and 3-,5-years | 
| Stroke |  | 1-,6-, and 12-months, and 3-,5-years | 
| Procedural success | Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotational atherectomy