AIH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol will be repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks. After this AIH protocol, patients will received body weight-assisted treadmill training (BWSTT) for 45 minutes.

Sham protocol: it consists of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks.After this AIH protocol, patients will received body weight-assisted treadmill training (BWSTT) for 45 minutes.

IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.

Intermittent Hypoxia Arm

Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.

Normoxia Arm

Total

Sex: Female, Male

Region of Enrollment

The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.

Gait Speed With 10-Meter Walk Test

The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.

IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.

Gait Endurance With the 6-Minute Walk Test

The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.

Gait Speed With the Timed up and go Test

The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).

Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale

The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).

Percentage of Subjects With Worsening Pain Perception on the "The Visual Analog Test"

The ROCF is a neuropsychological instrument used for assessment of episodic visual memory.
Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.
Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation

Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test

The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory.
Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.
Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation

Learning and Memory With the Complutense Verbal Learning Test (TAVEC)

Acute Intermittent Hypoxia Arm

Overall Study

Dr. Angela Navarrete-Opazo

Spinal Cord Injuries

Patients will breath 9% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.

Acute Intermittent Hypoxia

Patient´s gait will be trained through a weight-assisted treadmill (BWSTT). All recruited patients will start BWSTT at a speed of 0.6 km/hr. The physical therapist will manually correct posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training will be done immediately after the protocol of AIH or Sham and it will last 45 minutes.

Body weight-assisted treadmill training

It consists of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks.

Sham Protocol

Hospital Mutual de Seguridad

Instituto de Rehabilitación Infantil Teletón

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training: a Potential Therapy for Incomplete Spinal Cord Injury Patients

Angela A Navarrete-Opazo, MD, PhD

Angela A Navarrete-Opazo MD, PhD

Sociedad Pro Ayuda del Niño Lisiado

Hospital Clinico Mutual de Seguridad

Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month

Perinatal White Matter Brain Injury

Magnetic Resonance Imaging

Validated battery of neurodevelopmental and psychological tests.

Neurodevelopmental Testing

Children's Hospital of Pittsburgh of UPMC

MR Imaging of Perinatal Brain Injury

Advanced MR Imaging of Perinatal Brain Injury: Correlation With Neurocognitive Outcome

Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development.

Materials generated under the project will be disseminated in accordance with the University of Pittsburgh and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement.
Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.

Ashok Panigrahy

University of Pittsburgh

15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns patients will receive a sham injection. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.

Avastin

Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.

Triamciolone

After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.

Lucentis

Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome

Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.

Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.

Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.

Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.

Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome

Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)

Area of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.

To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.

15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.

Bevacizumab vs Triamcinolone

Ranibizumab vs Triamcinolone

Dr. Katharina Kriechbaum

Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.

Diabetic Macular Edema

The intravitreal injection of Bevacizumab (Avastin®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Bevacizumab (Avastin)

The intravitreal injection of triamcinolone (Volon A®) is performed in the operating room under sterile conditions at baseline. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Triamcinolone

Patients receiving sham intravitreal injections do not receive an actual injection of study drug. The injecting physician performing the sham injection will be unmasked to the treatment to the treatment assignment regarding active versus sham. The injecting physician will perform the same pre-injection procedures for the patients receiving bevacizumab or triamcinolone, An empty syringe without a needle will be used in the sham injection. The injecting physician will mimic an intraocular injection by making contact with the conjunctiva and applying pressure without the needle. Immediately following the sham injection, the injecting physician will perform the same post-injection procedures as those performed on patients receiving bevacizumab or triamcinolone.

Sham

The intravitreal injection of Ranibizumab (Lucentis®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.05ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Dept. of Ophthalmology, Medical University of Vienna

Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema

A Randomized, Double-masked Study With Intraocular Anti-VEGF (Avastin®/Lucentis®) Compared With Intraocular Triamcinolone (Volon A®) in Patients With Clinical Significant Diabetic Macular Edema

gliosis/hypoxia

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

MR Imaging of Perinatal Brain Injury

Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema

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