Eye Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Cataract

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Liver Diseases

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Heart Diseases

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Arrhythmias, Cardiac

Peripheral Nervous System Diseases

Hypersensitivity

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Seizures

Myocardial Ischemia

Lung Diseases, Interstitial

Vertigo

Dizziness

Leukemia, T-Cell

Sleepiness

Thromboembolism

Hypothyroidism

Hypotension, Orthostatic

Confusion

Leukemia-Lymphoma, Adult T-Cell

Tumor Lysis Syndrome

Teratogenesis

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

Revlimid

BMS Study Connect Contact Center www.BMSStudyConnect.com, Study manager

First line of the email MUST contain the NCT# and Site #.

Bristol-Myers Squibb

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Number of participants with adverse events

Celgene

Delirium

Psychomotor Agitation

Neurobehavioral Manifestations

Neurologic Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Acute Graft Versus Host Disease

Cancer patient who recently experienced confusion or restlessness.

Caregivers of cancer patients who recently experienced confusion or restlessness.

Questionnaire

Eduardo Bruera, MD

Primary Objectives:

1. To determine the proportion of patients who experience partial or complete recollection of symptoms of delirium and the level of distress associated with this recall.
2. To determine caregiver's level of distress associated with the patient's episode of delirium.

Informed Consent for Patients:

Delirium is often seen in patients with advanced cancer. Delirium is defined as confusion and restlessness. In this study, cancer patients will be asked about their memory of experiencing delirium and the distress related to those memories. Caregivers of those patients will also be asked to participate, and they will be asked questions about their experience during these situations.

You will be tested using the Memorial Delirium Assessment Scale to see if you have recovered from your delirium. If you are still eligible to take part in this study, and both you and your caregiver agree to participate in this study; you will be asked by the research nurse to complete several questionnaires that ask questions about your mental state, any memory of experiencing delirium, the severity of the delirium, symptoms you experienced during the delirium episode, and your level of emotional distress related to that event. If you and your caregiver are asked to participate in this study; you will also be asked "open-ended" questions (questions with no wrong answers) regarding the experience you had during the severe episode of delirium; your memories of the experience, and the overall distress related to it. This conversation will be tape recorded, and it will be written down word-for-word, for the purpose of analysis. The conversation is expected to last no more than 30 minutes.

The assessments and questionnaires will be conducted only at the time of interview. No further assessments or questions will be done after the completion of the study. All information collected for the study will be kept confidential. You will be assigned a study participant number when you enroll on the study, and this number will be used (instead of your name) on all data collections, to protect your confidentiality.

This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Informed Consent for Caregivers:

Delirium is often seen in patients with advanced cancer. Delirium is defined as confusion and restlessness.

In this study, you will be asked about your memory of your family member's experience of delirium, and the distress related to those memories. The patient you are caring for will also be asked to participate, and they will be asked questions about their experience during these situations.

If you are eligible to take part in this study, and both you and your family member agree to participate in this study, you will be asked by the research nurse to complete several questionnaires that ask questions about your family member's mental state, your memory of your family member's experience of delirium, the severity of the delirium, symptoms your family member experienced during the delirium episode, and your level of emotional distress related to that event. If you and your caregiver are asked to participate in this study; you will also be asked "open-ended" questions (questions with no wrong answers) regarding the experience you had during your family member's severe episode of delirium, your memories of the experience, and the overall distress related to it. This conversation will be recorded using a tape recorder, and it will be written down word for word, for the purpose of analysis. The conversation is expected to last no more than 30 minutes.

The assessments and questionnaires will be conducted only at the time of interview. No further assessments or questions will be done after the completion of the study. All information collected for the study will be kept confidential. You will be assigned a study participant number when you enroll on the study, and this number will be used (instead of your name) on all data collections, to protect your confidentiality.

This is an investigational study. Up to 100 cancer patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Delirium Recall in Advanced Cancer Patients

The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers

Level of distress patients experience associated with delirium recall, made on a 0-4 numerical rating scale with 0=not at all and 4=extremely distressed. Summarized as a median score and as the most frequent response.

Interview with full assessment including demographic information, MMSE (Mini-Mental State Exam), DEQ (The Delirium Experience Questionnaire), and Delirium Recall Questionnaire for patient who experience complete recovery from an episode of delirium

M.D. Anderson Cancer Center

Cancer Pain

Pain

Quality of Life

Central Nervous System Stimulants

Analgesics

Central Nervous System Depressants

Anti-Infective Agents

Other Dietary Supplements

Caffeine

Analgesics, Opioid

Sodium Benzoate

Caffeine, sodium benzoate drug combination

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Neurotransmitter Agents

Clotrimazole

Miconazole

Antifungal Agents

Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour

Intravenous injections of 100ml of normal saline over 1 hour

Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.

Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days

Normal saline

Sang-Yeon Suh, M.D.,Ph.D

Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.

Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.

Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain

Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.

Korea University Guro Hospital

Korea Research Foundation

Sang-Yeon Suh

Placebo

Total

Age Continuous

Sex: Female, Male

Korea, Republic of

Region of Enrollment

Drowsiness

Nausea

Sleep

Sadness

Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of symptoms.

Symptom score

Health-related quality of life

Daily living

Mode

Work

Interpersonal relationship

Gait ability

Life enjoyment

Impact of symptom burden to daily life (by MD Anderson Symptom Inventory-Korean)

Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids

Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10

Health-related Quality of Life

Mood

Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)

Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids

Overall Study

Acute Kidney Injury

Depression

Multiple Myeloma

Neoplasms, Plasma Cell

Pneumonia

Jaundice

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Pomalidomide

Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Jinshu Cho

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
Delirium Recall in Advanced Cancer Patients	NCT00493714	Advanced Cancer Delirium	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Delirium Recall in Advanced Cancer Patients	NCT00493714	Advanced Cancer Delirium	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain	NCT00879775	Cancer Pain	Caffeine Normal saline	18 Years -	Korea Research Foundation
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain	NCT00879775	Cancer Pain	Caffeine Normal saline	18 Years -	Korea Research Foundation
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg	NCT02921828	Multiple Myelom...		18 Years -	Celgene

Spots Global Cancer Trial Database for confusion

Every month we try and update this database with for confusion 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 confusion

Every month we try and update this database with for confusion 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 confusion 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.