Parkinson Disease

MRI if indicated

Gut Microbiota and Parkinson's Disease

the QIAamp DNA Stool mini kit to extract total bactria DNA Some genetic risk factors may play a crucial role in the interactions between the brain-gut-microbiota axis with respect to gut inflammation. It has been also shown that the methylation status in the SNCA promoter region may affect α-syn expression and the risk for PD

Alaa E Ahmed

Doctor

Arm A:
Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.

Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily.
Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
Mometasone furoate cream is used in the treatment of inflammatory skin disorders. In terms of steroid strength, it is more potent than hydrocortisone, and less potent than dexamethasone. It reduces inflammation by causing several effects such as reversing the activation of inflammatory proteins, activating the secretion of anti-inflammatory proteins, stabilizing cell membranes, and decreasing the influx of inflammatory cells. The exact anti-inflammatory mechanism of action is unknown.

Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
Mepitel® Film: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.

Arm A: Treatment With Mepitel® Film

Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.

Arm B: Treatment With Standard Care

Total

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

Tumor site

For assessment of the tumor stage, the folllwoing classification was used (American Joint Committee on Cancer):
Stage I: T1NoMo Stage II: T2NoM0 Stage III: T1-3N1M0, T3N0M0 Stage IV: T1-3N2M0, T4aN0-2M0 (IVa); T1-4N3M0, T4bN0-3M0 (IVb); T1-4N0-3M1 (IVc)
A higher stage is associated with a worse prognosis.

Tumor stage (American Joint Committee on Cancer)

For the histologic grading, the following classification was used:
GX Grade cannot be assessed G1 Well differentiated (Low grade) G2 Moderately differentiated (Intermediate grade) G3 Poorly differentiated (High grade) G4 Undifferentiated (High grade)
A higher grade is generally associated with a worse prognosis.

Histologic grading

Human papilloma virus (HPV) status

Surgery prior to radiotherapy

Performance status was rated with the Eastern Cooperative Oncology Group (ECOG), ranging from 0 to 5 (lower grade=better performance status).
0: Fully active without restrictions.
Restricted in physically strenuous activity; ambulatory and able to perform light or sedentary work.
Ambulatory and capable of all self-care; unable to work; up and about >50% of hours awake.
Capable of limited self-care; confined to bed/chair >50% of hours awake.
Completely disabled. Totally confined to bed or chair.
Dead.

Eastern Cooperative Oncology Group performance score

Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.

Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and were treated per protocol.

Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)

Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and were treated per protocol.

Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and were treated per protocol.

Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)

Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)

Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)

Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and belonged to the intention-to-treat population.

Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 50 Gy of radiotherapy and belonged to the intention-to-treat population.

Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)

Patients treated with Mepitel® Film who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and belonged to the intention-to-treat population.

Patients treated with Standard Skin Care who were evaluable for radiation dermatitis at 60 Gy of radiotherapy and belonged to the intention-to-treat population.

Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)

Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)

Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)

The number of fractions of radiotherapy up to 50 Gy (50 Gy = 25 fractions) was counted in the intent-to-treat population, until grade 2 radiation dermatitis occurred.

Patients treated with Mepitel® Film who were evaluable for radiation dermatitis up to 50 Gy of radiotherapy and belonged to the intention-to-treat population.

Patients treated with Standard Skin Care who were evaluable for radiation dermatitis up to 50 Gy of radiotherapy and belonged to the intention-to-treat population.

Median Number of Radiation Fractions Until Occurence of Grade 2 Dermatitis

The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.

Patients treated with Mepitel® Film who were evaluable for pain at baseline and at 50 Gy of radiotherapy and belonged to the intention-to-treat population.

Patients treated with Standard Skin Care who were evaluable for pain at baseline and at 50 Gy of radiotherapy and belonged to the intention-to-treat population.

Median Pain Score at the Irradiated Skin at 50 Gy

Patients treated with Mepitel® Film who were evaluable for pain at baseline and at 60 Gy of radiotherapy and belonged to the intention-to-treat population.

Patients treated with Standard Skin Care who were evaluable for pain at baseline and at 60 Gy of radiotherapy and belonged to the intention-to-treat population.

Median Pain Score at the Irradiated Skin at 60 Gy

Quality of Life was assessed using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.
For QLQ-C30, scoring of global health status and functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning) were assessed. Scores ranged from 0 to 100. A higher score represented a higher level of quality of life (global health status) and a higher level of functioning (functional scales).
For QLQ-H&N35, symptom scales (pain, problems with swallowing, senses problems, speech problems, trouble with social eating, trouble with social contact) were assessed Scores ranged from 0 to 100. A higher score represented a higher level of symptomatology/problems.
For both questionnaires (QLQ-C30 and QLQ-H&N35), the change between baseline and follow up at 50 Gy for each item was calculated by using the mean value of the differences between both time points of the evaluable patients.

Patients treated with Mepitel® Film who were evaluable for quality of life at baseline and at 50 Gy of radiotherapy.

Patients treated with Standard Skin Care who were evaluable for quality of life at baseline and at 50 Gy of radiotherapy.

Change in Quality of Life Between Screening and 50 Gy of Radiotherapy

Overall Study

Prof. Dr. med. Dirk Rades

Head and Neck Neoplasms

Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.

Mepitel® Film

Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily.
Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.

Standard Care

Department of Radiotherapy (Radiooncology), Christian-Albrechts-Universität zu Kiel and University Medical Center Schleswig-Holstein Campus Kiel

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer

Radiotherapy Related Skin Toxicity: Mepitel® Film vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer

Prof. Dirk Rades, MD

Professor Dr. med.

University of Schleswig-Holstein

patient will receive a fix dose of 75 μg of palonosetron

patient will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron

Postoperative Nausea and Vomiting

receive a fix dose of 75 μg of palonosetron (group I - GI) and another forty patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII).

palonosetron

National Cancer Institute (INCA - HCIII)

Compare Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients

Comparative Study Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients Undergoing Breast Surgery

To determine the frequency of individual episodes of nausea and vomiting in the periods of 6 hours postoperatively

To determine the frequency of individual episodes of nausea and vomiting in the period of 24 hours postoperatively

Compare need of antiemetic rescue medication during the periods of 48 hours postoperatively

Determine the number of patients who had complete antiemetic response (absence of nausea, vomiting and need for rescue medication)

To determine the frequency of individual episodes of nausea and vomiting in the periods of 48 hours postoperatively

To evaluate the frequency of polymorphism of the 5-HT3 receptors and their correlation with the antiemetic effect and adverse effects

Even if this data is used for scientific publication, patient identification will remain secret

5 hydroxytryptamine/carie dentară

Gut Microbiota and Parkinson's Disease

Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer

Compare Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients

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