linjc16/ctgov huggingface dataset:
Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Study Overview
=================
Brief Summary
-----------------
Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

Official Title
-----------------
Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Everolimus
* Drug: Tacrolimus
* Drug: Mycophenolate sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving a first kidney transplant from a cadaveric or living donor Exclusion Criteria: Double transplant Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Everolimus-Tacrolimus<br>Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml), Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml). | Drug: Everolimus<br>* Active Comparator<br>* Other names: Certican®;Drug: Tacrolimus<br>* Active Comparator<br>* Other names: Prograg®;|
| Experimental: Everolimus-Mycophenolate sodium<br>Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml), Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day. | Drug: Everolimus<br>* Active Comparator<br>* Other names: Certican®;Drug: Mycophenolate sodium<br>* Experimental Arm<br>* Other names: Myfortic®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function as measured by estimated glomerular filtration rate GFR | GFR unit : mL / min / 1.73 m2 | One year after inclusion |
Effect of Dexmedetomidine on the Inflammatory Response After One-lung Ventilation

Study Overview
=================
Brief Summary
-----------------
The postoperative inflammatory response is significant in lung resection surgery because of major operation and one-lung ventilation. Dexmedetomidine has been shown to reduce pro-inflammatory cytokine levels and improve clinical outcomes. The aim of this study was to determine the effects of dexmedetomidine on inflammatory responses after lung resection surgery.

Official Title
-----------------
Effect of Dexmedetomidine on the Inflammatory Response in Patients Undergoing Lung Resection Surgery

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective video-assisted thoracoscopic surgery (VATS) lobectomy 20 < age < 75 American Society of Anesthesiologists (ASA) classification I II Exclusion Criteria: preoperative inflammation (CRP>10ng/#, WBC>10,000/mm3, body temperature >38#) steroid administration within 1 month hematologic / autoimmune disease congestive heart failure (NYHA class III IV) or significant arrhythmia severe obstructive / restrictive pulmonary disease previous history of thoracic surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Saline group<br>Patients in the saline group were infused with an identical volume of normal saline. | |
| Experimental: Dexmedetomidine group<br>Patients in the dexmedetomidine group were infused with a loading dose of dexmedetomidine (1.0 mcg/kg over 10 min) and were thereafter infused at a rate of 0.5 mg/kg/h. | Drug: Dexmedetomidine<br>* The study drug for each group was administered from the time immediately after induction of anesthesia until the end of the surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin (IL)-6 | Blood samples were collected from the antecubital vein | 24 hours after surgery |
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Study Overview
=================
Brief Summary
-----------------
If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.

Detailed Description
-----------------
Not required

Official Title
-----------------
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects fulfilling the following criteria will be eligible: males and females, 18 to 50 years of age; non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers; Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III); female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period Exclusion Criteria: history of significant hypersensitivity reaction to any components of Tygacil®; history of significant clinical illness requiring pharmacological management; history of blood donation in the past eight week period; abnormal serum electrolyte or complete blood count requiring further clinical work-up; transaminases (AST or ALT) > 2.5 x upper limit of normal; subjects with stage 4 or 5 chronic kidney disease; positive serum pregnancy test (if female); abnormal electrocardiogram (ECG) as judged by study physician; unable to tolerate venipuncture and multiple blood draws; clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up; unable to independently provide a written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: Tigecycline<br>All subjects receive a single dose of tigecycline | Drug: Tigecycline<br>* 100 mg IV as a single infusion over 30 minutes<br>* Other names: Tygacil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours | The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L) | 4 days (96 hours) |
Connective Tissue Motion Measure

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) -quantifying the functional behavior of perimuscular connective tissues.

Detailed Description
-----------------
The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue.

Official Title
-----------------
Feasibility Study of Connective Tissue Motion Measure - a Biomarker for Perimuscular Connective Tissue Pathology.

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for LBP subjects: history of recurrent or chronic LBP for a minimum of 12 months ability to stand and walk without assistance ability to understand and read English ability to understand and sign a consent form Inclusion criteria for No-LBP subjects: no history of low back pain or any other chronic pain that has limited activities of daily living or work a numerical current pain index of less than 0.5. Exclusion Criteria for all subjects: previous severe back or low extremity injury or surgery major structural spinal deformity (scoliosis, kyphosis, stenosis) ankylosing spondylitis or rheumatoid arthritis neurological deficit (weakness and/or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica) neurological or major psychiatric disorder bleeding disorders corticosteroid or anticoagulant medication pregnancy worker's compensation or disability case in litigation for the LBP problem acute systemic infection BMI less than 21 or greater than 35

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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 |
| --- | --- |
| Chronic Low Back Pain<br> | |
| No Low Back Pain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Epidemiological Tool To Detect Angina Pectoris in Blacks

Study Overview
=================
Brief Summary
-----------------
To develop a prototype questionnaire for the detection of angina pectoris in Blacks.

Detailed Description
-----------------
BACKGROUND: Angina pectoris is often considered a manifestation of coronary artery atherosclerosis that is associated with an increased mortality risk. Overall, coronary heart disease is the leading cause of morbidity and mortality in United States Blacks. In an attempt to standardize the diagnosis of angina pectoris in epidemiologic studies, Rose developed a questionnaire for cardiovascular field surveys which has primarily been used in United States and other white populations. However, in 1988, there were no valid epidemiological tools for the assessment of angina pectoris in Blacks. The development of a cardiovascular survey instrument capable of assessing angina pectoris in Black populations was identified by the Association of Black Cardiologists as an urgent epidemiologic need. Also, such a survey instrument could ultimately enhance knowledge and treatment of cardiovascular disease among Blacks. 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, Angina Pectoris, Heart Diseases

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 |
| --- | --- | --- |
Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.

Official Title
-----------------
Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Other: 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histological diagnosis of neuroendocrine tumors Patients with indication for the staging exam with 11In Patients diagnosed in any tumor stage Patients with > 18 years Male and female patients Patients not receiving somatostatin analogues for at least 1 month before image capturing Exclusion Criteria: Pregnant women Patients with previous tumor resection of the primary tumor without metastatic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult patients with neuroendocrine tumors<br> | Other: 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide<br>* The patient will undercome an PET/CT exam with 99m Tc - HYNIC -TOC EDDA, after 20 days of wash out, the same patient will undercome the same exam with 111In - DTPA-octreotide in order to compare both radiopharmaceuticals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the images captured with 99m Tc - HYNIC -TOC EDDA ( octreotide labeled with 99mTc ) and 111In - DTPA-octreotide for the diagnosis of neurocrine tumors |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents |  | Up to 30 days | 
| Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents |  | Up to 30 days |
Antidiabetic Properties of Rose Hip

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease.

Official Title
-----------------
Effects of Rose Hip Intake on Risk Markers of Type 2 Diabetes and Cardiovascular Disease: a Randomized Double-blind Cross-over Investigation in Obese Persons

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Rose hip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 willingness to participate in the study willingness to comply with the daily intake of drinks and the recommended energy intake during the course of the study Exclusion Criteria: diabetes previous or ongoing insulin treatment abnormal thyroid status abnormal liver status abnormal kidney status known gastrointestinal disorder pregnancy suspected allergy to ingredients of the drinks

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rose hip<br> | Dietary Supplement: Rose hip<br>* 40 g of rose hip powder daily for 6 weeks.<br>|

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
-----------------
obesity, glucose intolerance, cholesterol, blood pressure
Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

Study Overview
=================
Brief Summary
-----------------
Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk. The investigators are examining this association in normal and impaired glucose tolerance patients groups.

Detailed Description
-----------------
We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum blood-normalized standardized uptake value (SUV), known as the target-to-background ratio (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular inflammation by FDG-PET scan.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: a history of cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization) active inflammatory disease, recent active infection stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg) diabetes mellitus systemic disorders such as severe hepatic, renal, and hematologic diseases taking drugs known to interfere with vascular inflammation measured by FDG-PET.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| normal<br>normal group has no diabetes. | |
| IGT<br>IGT group has impaired fasting glucose or impaired glucose tolerance. | |

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
-----------------
atherosclerosis, inflammation, hsCRP, Framingham risk score, positron emission tomography, inflammation in FDG-PET
Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.

Official Title
-----------------
A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with Type I diabetes: Children must be 5 years of age or less at the time of entry into the study. Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry. Children must be receiving two or more insulin injections daily. Exclusion Criteria: Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase. Children must not have any other chronic illness in addition to diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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 |
| --- | --- |
| Insulin Pump Therapy<br>Children starting insulin pump therapy | |
| Insulin Injections<br>Children remaining on insulin injections. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HgBA1c |  | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, continuous glucose sensor monitoring