linjc16/ctgov huggingface dataset:
Intraperative Assessment of Renal Perfusion Using Infrared Imaging

Study Overview
=================
Brief Summary
-----------------
Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.

Detailed Description
-----------------
Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.

Official Title
-----------------
Intraoperative Assessment of Renal Perfusion Using Infrared Imaging

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: NIH Transplant Reccipients of living related, living unrelated, and cadaveric kidney transplants who underwent intra-operative IR/NIRS imaging. EXCLUSION CRITERIA: None
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
-----------------
Infrared, Imaging Techniques, Kidney Reperfusion, Pneumoperitoneum, Nephrectomy
The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children

Study Overview
=================
Brief Summary
-----------------
To examine the impact of a structured physical activity program focused on bone strength in elementary school children in the framework of their physical education classes on: Bone strength of children participating in the activity. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.

Conditions
-----------------
Bone Strength, Bone Density

Intervention / Treatment
-----------------
* Other: Upper Limb Exercises
* Other: Normal physical exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First and second grade pupils Healthy Exclusion Criteria: Medical condition does not permit participation in physical education class

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Group<br>Children doing additional exercises with upper limbs in physical education class | Other: Upper Limb Exercises<br>* Upper limb exercises<br>|
| Active Comparator: Control Group<br>Children doing normal physical education exercises | Other: Normal physical exercises<br>* Exercises usually done by children in physical education classes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone strength | Examination of bone strength will be carried out by using a measuring device called Sunlight Omnisense. This device uses SOS (Speed of Sound) to check bone strength and density. | One year | 
| Bone density | Examination of bone density will be carried out by using a measuring device called Sunlight Omnisense. This device uses SOS (Speed of Sound) to check bone strength and density. | One year |
Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery. The primary objectives are to: Develop and implement a pain booklet to improve pain management after cardiac surgery Evaluate the effect of the pain booklet compared to a group of patients given usual care

Official Title
-----------------
AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery

Conditions
-----------------
Pain, Pain, Postoperative, Other Functional Disturbances Following Cardiac Surgery

Intervention / Treatment
-----------------
* Behavioral: Pain Booklet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing their first elective CABG, valve surgery or a combination receiving the standard preadmission information able to take care of themselves after discharge able to read and write Norwegian and fill in the questionnaires able to be contacted by telephone Exclusion Criteria: more than 12 hours at the intensive care unit after surgery

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain booklet<br> | Behavioral: Pain Booklet<br>* The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients<br>|
| No Intervention: standard care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Change from Baseline in pain intensity at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360 | Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360 | 
| pain-related interference | Change from Baseline in pain-related interference at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360 | Baseline, day 7, day 30, day 90, day 180, day 360 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic intake |  | baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360 | 
| Quality of life |  | baseline, day 7, day 90, day 180, day 360 |
New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.

Detailed Description
-----------------
DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.

Official Title
-----------------
Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: L-asp, DXM, IFO, VP-16, DDP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 14-75 years old Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract ECOG performance status less than 2 Life expectancy of more than 3 months Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet > 100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN Exclusion Criteria: Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Ages Eligible for Study
-----------------
Minimum Age: 14 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: L-DICE<br> | Drug: L-asp, DXM, IFO, VP-16, DDP<br>* L-asp 6000 u/m2; DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 60 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.<br>* Other names: L-DICE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate, PFS and OS |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NK/T cell lymphoma, DICE, L-asparaginase
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy

Official Title
-----------------
A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy

Conditions
-----------------
Hypertension, Diabetes, Proteinuria

Intervention / Treatment
-----------------
* Drug: trandolapril/verapamil
* Drug: Lotrel (amlodipine/benazepril)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Hypertension Albuminuria Exclusion Criteria: Type 1 DM. Subject has severe hepatic dysfunction at Screening as determined by liver function tests: Bilirubin > 2.0 mg/dL. ALT and/or AST > 3 times the upper limit of normal. Subject has poorly controlled diabetes, based on HbA1c > 10% at Screening. Subject has non-diabetic renal disease. Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.

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: 1<br> | Drug: trandolapril/verapamil<br>* 2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD<br>* Other names: Tarka;|
| Active Comparator: 2<br> | Drug: Lotrel (amlodipine/benazepril)<br>* 5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urinary albumin:creatinine ratio |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events. |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Diabetes, Proteinuria, Tarka, Lotrel
Postoperative Pain Management in Hospital and Following Discharge From Hospital.

Study Overview
=================
Brief Summary
-----------------
To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.

Detailed Description
-----------------
We hypothesize that patients experience more postoperative pain at home than they do in hospital and factors such as preoperative anxiety, depression, and preoperative pain affect the level of postoperative pain experienced by patients. A total of 200 patients undergoing total knee surgery will be enrolled in this observational study. They will be asked to fill a baseline questionnaire including demographic information, medical problems, anxiety, depression, preoperative pain level, etc. Following routine standard anesthesia and surgery, patient's pain will be assessed every 4 hours when they are in the hospital after surgery, then daily assessment for 1 week after they are discharged home followed at 2 months, and 6 months after surgery.

Official Title
-----------------
Assessment of Postoperative Pain Management in Patients Undergoing Total Knee Arthroplasty Immediately After Surgery and Following Discharge From Hospital.

Conditions
-----------------
Arthropathy of Knee Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing total knee arthroplasty Exclusion Criteria: Patients attending rehabilitation facilities after discharge unwilling or unable to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Postoperative pain management<br>The postoperative pain level will be assessed during hospitalization and at home, in patients undergoing total knee replacement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Pain scores (at rest & with exercise) will be collected during the hospital stay | during hospital stay (average 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative anxiety scores | Analysis of preoperative anxiety scores. | preoperative | 
| Preoperative depression scores | Analysis of preoperative depression score. | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee arthroplasty
Linezolid in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Linezolid is the first synthetic antibiotic of oxazolidinone group that can inhibit bacterial protein synthesis. Previous studies have found that linezolid was an effective treatment for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). In addition, the current dosage recommendation (1,200 mg/day) occasionally resulted in serious adverse events including bone marrow suppression and peripheral neuropathy. The objective study were determine the pharmacokinetics of oral linezolid 300 mg /day in healthy volunteers. This study conducted in six healthy volunteers. All subject received an oral linezolid 300 mg/day by directly observed treatment (DOT) at the same time each day for 5 days. Blood samples were collected on day 5 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h post dosing. The separated plasma samples were evaluated by ultra-performance liquid chromatography (UPLC). All pharmacokinetic parameters were calculated.

Official Title
-----------------
Pharmacokinetics/Pharmacodynamics of Oral Linezolid 300 mg/Day in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Linezolid oral tablet 300 mg/day for 5 day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 - 40 BMI 19 - 24 kg/m2 normal CLcr normal liver function Exclusion Criteria: Subject who pregnant Subject who have documented hypersensitivity to linezolid

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: linezolid 300 mg<br> | Drug: Linezolid oral tablet 300 mg/day for 5 day<br>* Linezolid oral tablet 300 mg/day for 5 day and blood sample were obtained by direct venipuncture at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hour after drug administration in day 5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of linezolid in plasma | Individual concentration of linezolid in plasma | 24 hour after the linezolid dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetic, linezolid, healthy volunteers
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.

Official Title
-----------------
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with GERD ranged from 42 to 56 years Exclusion Criteria: patients with cardiac disease patients with renal affection patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis) patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 56 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>9 healthy normal subjects. | |
| Active Comparator: Group II<br>Included 9 patients suffering from GERD; receiving melatonin alone for treatment of GERD in a dose of 3 mg once daily at the bed time. | Drug: Melatonin<br> <br> |
| No Intervention: Group III, combined group<br>Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily. | |
| Active Comparator: Group IV<br>Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them. | Drug: Melatonin<br> <br> |

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

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