Nervous System Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Migraine Disorders

Ganglion Cysts

Synovial Cyst

Cysts

Headache

Headache Disorders

Headache Disorders, Primary

Brain Diseases

Central Nervous System Diseases

Mucinoses

Connective Tissue Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Vasodilator Agents

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.

Botulinum toxin type A

0.5 ml Sodium Chloride (NaCl) 0.9% Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.

placebo

Tore Wergeland Meisingset, Md phd

Erling Tronvik, md phd

Marte-Helene Bjørk, MD phd

Karl Bjørnar Alstadhaug, md prof

John-Anker Zwart, MD prof

Geir Bråthen, md phd

This is a clinical trial to assess the efficacy of botox treatment of the sphenopalatine ganglion as an add-on treatment in drug resistant migraine. An injection targeting the ganglion is made possible by an image-guided device developed specifically for this purpose (MultiGuide) Study participants will be randomized to either placebo or botox after a 4 week run-in period. First, one injection will be given towards both the right and the left ganglion. After that there will be a follow-up of 12 weeks for efficacy and safety evaluation. The main efficacy measure is change in number of moderate to severe headache days before and after injection.

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

all IPD that underlie results in a publication will be shared within 6 months after study results publication

Change from baseline to week 5-8 post-intervention in frequency of moderate to severe headache days. Headache episodes that qualify is in the study defined as headache pain duration of ≥4 hours with a peak severity of moderate or severe intensity, or of any severity or duration if the subject takes and responds to rescue medication.

All adverse events and serious adverse events occurring in the 3 months follow up are registered in an electronic CRF. Frequency of AE and SAE are compared between the placebo group and the treatment group

A migraine day is defined as one day with headache pain fulfilling the ICHD3-criteria for migraine or probable migraine. However, a headache duration of less than 4 hours is allowed if the subject takes and responds to triptans. The frequency of headache days in the baseline period are compared to the frequency in week 5-8 post-intervention

A 30% treatment response is defined as a patient with a ≥ 30% reduction in frequency of headache days during weeks 5 - 8 post-intervention compared to baseline. Headache is defined as in the primary outcome, i.e. moderate to severe headache days. The number of responders is compared between the intervention and the placebo group

Attack intensity is reported daily on a 11-point numerical response scale (NRS) in the electronic headache diary. The mean attack intensity in week 5 - 8 post-intervention is compared to baseline in the active group versus the placebo group.

The difference in hours with NRS ≥4 in the baseline period and weeks 1-4, 5-8 and 9-12 post injection are compared between the active group and the placebo group

Any use of rescue medication is reported in the headache diary every day. The number of days with registered use of any headache related rescue medication in weeks 1-4, 5-8 and 9-12 post-intervention is compared to the baseline period

Study participants will fill in the 6-question Headache impact test (HIT-6) at visit 1 (at inclusion) and at week 8 and week 12 postintervention. Scores are compared between the placebo and the treatment group

Study participants will fill in the 14-question Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ) at visit 1 (at inclusion) and at week 8 and week 12 postintervention. Scores are compared between the placebo and the treatment group

Norwegian University of Science and Technology

Oslo University Hospital

Haukeland University Hospital

Nordlandssykehuset HF

St. Olavs Hospital

Wounds and Injuries

Musculoskeletal Diseases

Immune System Diseases

Gland and Hormone Related Diseases

Osteoarthritis

Arthritis

Arthritis, Rheumatoid

Thyroid Diseases

Pain

Thyroid Nodule

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Central Nervous System Depressants

Anesthetics

The intervention is the use of the reciprocating procedure device (RPD) (AVANCA Re No. 1091001) (intervention) (Arm 1) with and without ultrasound guidance (intervention) in a syringe and needle procedure in comparison to a conventional syringe (BD Ref 309604) (control, Arm 2).

The conventional syringe (BD Ref 309604) is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined) and compared to Arm 1.

The RPD is a safety syringe device that is hypothesized to be safer, less painful, and more effective for patients undergoing a syringe and needle procedure (please see arm #1).

Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001

the conventional syringe or the RPD will be used for syringe and needle procedures performed by physicians.

conventional syringe - BD Ref 309604

Wilmer L Sibbitt, Jr., MD

The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures with a standard syringe or the new reciprocating procedure device (RDP), which is a type of safety syringe. Over a 5 year period, 820 subjects who require and assent to a syringe and needle procedure for their usual and customary care will be randomized to either a conventional syringe or the RPD with one arm with and without ultrasound guidance. The RPD is designed to be safer, faster, less painful, and more effective for the patient, and the mechanics of the RPD are intended to provide the physician with better needle control, resulting in less needle trauma to patient tissues, and thus, reduced bleeding and pain for the patient. This clinical trial will address whether the RPD is indeed superior to the conventional syringe for shots, injections, and needle procedures, and whether it is a safer, less painful syringe.

\* BACKGROUND

The syringe is an ancient device designed principally to inject medications. However, because of the inherent biomechanics of the human hand and the interaction of the hand with the piston, the syringe is very stable and easily controlled the injection phase, but is extremely unstable and difficult to control in the aspiration phase. New reciprocating technology that accommodates the biomechanics of hand function has great promise of improving the stability and safety of hand-held devices, including procedure syringes.

\* EXPERIMENTAL DESIGN AND METHODS

The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures accomplished either with a standard syringe or the new reciprocating procedure device (RDP). Over a 5 year period, 820 subjects who require and assent to a syringe procedure for their usual and customary care will be randomized to either a conventional syringe or the reciprocating syringe. The following syringe procedures will be studied: 1) local anesthesia, 2) centesis (arthrocentesis, paracentesis, thoracentesis, amniocentesis, pericardiocentesis), 3) aspiration and puncture (aspiration of bursa, cyst, abscess, shunt, bone marrow, and other syringe aspiration procedures), 4) injection of a therapeutic or diagnostic substance into a joint, bursa, vessel, or other body structure, 5) fine needle biopsy with syringe vacuum of a mass or tissue, 6) irrigation procedures (wound, bladder, and other irrigation procedures), and 7) vascular access (introduction of a wire, catheter, or sheath into a blood vessel), and 8) with and without ultrasound guidance.

In a subject with multiple individual procedure sites, or requires multiple separate biopsies, each will be randomized between the two syringes, and each biopsy or fluid sample will be analyzed separately (as is medically appropriate). The physicians who will perform the syringe procedures will be those physicians who usually perform the syringe procedures and are credentialed to do so. Outcome data collection will occur first by one of the investigators observing the procedure and collecting the data by real time interview and by chart review including cost analysis. Outcome data will include effectiveness (preprocedural pain, pain at 2 weeks post procedure, and pain at 6 months postprocedure), procedure time, patient pain, operator satisfaction, trauma to tissues, complications, diagnostic yield, overall medical care costs and hospital stay. Retrospective review of 30 charts of the device used clinically has also been approved (2006). Analysis of data will be performed by a statistician blinded to treatment group.

\*SIGNIFICANCE: The proposed study will be the first to study the clinical performance characteristics of a medical device that incorporates the new reciprocating technology designed to take advantage of the inherent biomechanical stability characteristics of the human hand. The preclinical studies presented in the preliminary data demonstrate markedly enhanced device performance characteristics, and much greater control and stability, strongly suggesting that reciprocating devices will be safer, more effective, more economical, and provide better patient outcomes.

Reciprocating Medical Devices - a Study of a New Safety Device

Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures

0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.

0- 10 cm visual analogue satisfaction scale (VASS)

0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure

University of New Mexico

The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.

1Conventional Syringe

Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.

2RPD Syring

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Wilmer L. Sibbitt, MD, Principal Investigator

2RPD Syringe

Pain Using VAS (Visual Analogue Pain Scale)

Aspirated Fluid Volume

Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation)

group comparisons using t-test and confidence intervals.

Physician Satisfaction

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Hormones

Hormone Antagonists

Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy

Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy

Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.

Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy

Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.

degarelix injection

Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.

androgen deprivation therapy

Dana Rathkopf, MD

Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone levels in the body.

Degarelix is commonly given with radiation for prostate cancer, but less frequently with surgery since there has been no proven benefit with this approach.

The investigators do not expect the patient to benefit directly from treatment with degarelix since their prostate will be removed shortly after the drug is given. Instead, the investigators hope to learn about how degarelix and other treatment that lowers your testosterone effects prostate cancer cells and use this information to develop better treatments in the future.

Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

Establishing a Neo-Adjuvant Platform for Developing Targeted Agents: Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

The primary endpoint is the change in the rate of proliferation (Ki-67) and the rate of apoptosis (cleaved caspase-3), as evaluated by IHC in anatomically matched tumor foci from the pre-treatment diagnostic biopsy and the RP specimen. The levels in pre-treatment biopsy serve as the baseline. Ki-67 is a widely accepted nuclear marker for cell proliferation. Cleaved caspase-3 has been shown to be a reliable marker of apoptosis and correlate with results from other apoptosis markers such as cleaved PARP-1 and TUNEL assay.

The secondary endpoint is PTEN status by IHC in the diagnostic biopsy and RP specimens. PTEN status will be determined by an IHC method that has been validated using control prostate cell lines and tissues at MSKCC. The PTEN status will be reported in binary fashion as "retained" (diffuse moderate immunoreactivity retained in benign glands as well as adenocarcinoma on 100X magnification) or "null" (complete loss of nuclear and cytoplasmic immunoreactivity in tumor cells while expression is retained in surrounding stroma.

Additional exploratory endpoints include IHC staining for markers of PI3K pathway (pAKT and pS6) as well as other markers of prostate cancer (ERG, AR and NCOA2) in the diagnostic biopsy and RP specimens. Some of these markers have been validated at MSKCC (pS6, ERG), while others (AR, pAKT, NCOA2) are currently being validated and standardized for the study using appropriate cell line and tissue controls. A general semiquantitative scoring method will be used for these markers.

through expression profiling of prostate cancer after three time intervals of androgen deprivation therapy and correlate with PTEN and ERG status, proliferation rate, apoptotic rate, and histologic response

Ferring Pharmaceuticals

Memorial Sloan Kettering Cancer Center

Cluster Headache

Neurologic Manifestations

Trigeminal Autonomic Cephalalgias

Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)

0.5 ml Sodium Chloride (NaCl) 0.9% Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)

Tore Wergeland Meisingset, md phd

Alexandre Thomas Assaf, dr

Massimo Leone, md prof

Miguel Lainez, md prof

Manjit Matharu, MD phd

Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

Change from baseline to weeks 5-8 post-intervention in number of cluster headache attacks per week in the active group versus the placebo group. The number of cluster headache attacks is collected in a headache diary.

All adverse events and serious adverse events occurring in the 3 months follow up are registered in an electronic case report form (CRF). Frequency of AE and SAE are compared between the placebo group and the treatment group

Change from baseline to weeks 9-12 post-intervention in number of cluster headache attacks per week in the active group versus the placebo group. The number of cluster headache attacks is collected in a headache diary

Change from baseline to weeks 5 - 8 post-intervention in number of cluster headache attacks per week comparing high versus low attack frequency and low versus high attack frequency variation in the entire baseline period. Comparisons are done between the active and the placebo group. The number of cluster headache attacks is collected in a headache diary

Change from baseline to weeks 9-12 post-intervention in number of cluster headache attacks per week comparing high versus low attack frequency and high versus low attack frequency variation in the entire baseline period. Comparisons are done between the active and the placebo group. The number of cluster headache attacks is collected in a headache diary

Number of therapeutic responders as defined as a ≥ 30% reduction in attack frequency, intensity or both during weeks 5 - 8 post-intervention compared to baseline week 5-8. The number in the placebo and intervention group are compared

Number of attack frequency responders as defined as a ≥ 30% reduction in attack frequency during weeks 5-8 post-intervention compared to baseline. The number in the placebo and intervention group are compared

Mean attack intensity (10-point numerical response scale - NRS) week 5-8 post intervention compared to baseline in the intervention group versus the placebo group.

University College, London

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Catholic University of Valencia

Universitätsklinikum Hamburg-Eppendorf

Mastocytosis

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Mast Cell Activation Disorders

Anti-Allergic Agents

Respiratory System Agents

Omalizumab

injections

01 Studienregister MasterAdmins

Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo, fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media, local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs. There is currently no specific treatment for this disease with the exception of rare cases. There are, however, some case reports suggesting that omalizumab might decrease symptoms including hypotensive events.

The aim of the study is to investigate whether patients suffering from mastocytosis benefit from a 6 month course of omalizumab with regard to symptoms and quality of life and whether the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the efficacy of omalizumab in patients with mastocytosis.

* Trial with medicinal product

The study will take place as double-blind placebo controlled study. After a first a run-period of 2 months for all participants randomization (1:1) in two group will take place:

Group A: With omalizumab treatment for 6 months; dosage and administration schedule according to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of the patients). After 4 months of treatment in both groups patients are encouraged to stop all drugs given to reduce mast cell related effects, mainly antihistaminics . In case that disturbing symptoms are reoccurring patients are allowed to restart these drugs. The evaluation will take place after 5 months of treatment.

Finally, a follow up visit 1 and 4 months after the study will take place.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine	NCT04069897	Migraine Disord...	Botulinum toxin... placebo	18 Years - 70 Years	St. Olavs Hospital
Reciprocating Medical Devices - a Study of a New Safety Device	NCT00651625	Osteoarthritis Rheumatoid Arth... Trauma Thyroid Nodule Cancer	Reciprocating P... conventional sy...	18 Years -	University of New Mexico
Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer	NCT01542021	Prostate Cancer Prostatic Adeno...	degarelix injec... degarelix injec... androgen depriv...	18 Years -	Memorial Sloan Kettering Cancer Center
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache	NCT03944876	Cluster Headach...	Botulinum toxin... placebo	18 Years - 85 Years	Norwegian University of Science and Technology
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients	NCT01333293	Mastocytosis	injections	18 Years - 70 Years	University of Zurich

Spots Global Cancer Trial Database for injections

Every month we try and update this database with for injections cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for injections

Every month we try and update this database with for injections cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for injections cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.