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NCT ID: NCT03593070 Completed - Clinical trials for Dementia Family Caregivers

Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention

CGMI-V
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The exponential rise in the number of persons diagnosed with Alzheimer's disease and related dementias (ADRD) places a heavy burden on family caregivers. The caregiver role that extends well beyond the placement of the care recipient in long-term care is associated with chronic grief, depressive and anxiety symptoms, dissatisfaction with care, and conflict with long-term care facility staff. This study will test the effects of a cost effective chronic grief management intervention to be delivered using an online platform (Adobe Connect) and iPads. The study aims to decrease dementia caregivers' chronic grief, depressive and anxiety symptoms, and to improve their positive states of mind; to improve satisfaction with care post-placement and to attenuate caregivers' conflict with facility staff.

NCT ID: NCT03595748 Completed - Dialysis Clinical Trials

Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This project tests a peer mentor intervention to improve outcomes in patients with end-stage renal disease (ESRD). The investigators will train peer mentors to deliver social support and to provide information and motivation in order to improve adherence behaviors and self management practices in assigned mentees who are also patients on maintenance hemodialysis. The intervention will consist of a weekly telephone call between mentor and mentee, over a period of 3 months. The study will recruit patients at 7 dialysis facilities (5 in the Bronx, NY and 2 in Nashville, TN) and randomize the patients to the peer mentorship intervention versus usual care. The primary outcome will be the sum of number of emergency department visits and hospitalizations during 3 months of intervention and 9 or 15 months of follow-up observation.

NCT ID: NCT03609853 Completed - Clinical trials for D-limonene and THC Pharmacodynamics

Behavioral Pharmacology of THC and D-limonene

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized d-limonene and THC administered via inhalation.

NCT ID: NCT03617705 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Alcohol Monitor Validation

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

NCT ID: NCT03625622 Completed - Clinical trials for Mild to Moderate Alzheimer's Disease

Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.

NCT ID: NCT03629535 Completed - Hypertension Clinical Trials

Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.

NCT ID: NCT03633630 Completed - Metabolic Syndrome Clinical Trials

Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Start date: April 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.

NCT ID: NCT03643744 Completed - Actinic Keratosis Clinical Trials

Photodynamic Therapy-Induced Immune Modulation: Part III

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

This study is designed as a double-blinded proof of concept of feasibility study to define if the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment with cyclo-oxygenase-2 (COX-2) inhibitor celecoxib in comparison to placebo. PDT consists of application of the photosensitizer 5-aminolevulinic acid followed by treatment with a blue light. PDT is used to treat pre-cancerous actinic keratosis on large areas of skin. These studies are a continuation of ongoing studies that indicate that the lipid mediator platelet-activating factor (PAF) is generated in skin following PDT, and that PDT suppresses the immune system. It is hypothesized that PDT-generated PAF results in the immunosuppression associated with PDT. Therefore, it is proposed that a treatment to block that immunosuppression could protect the patient undergoing PDT. Blockers of the PAF system are not currently commercially available. However research studies done at Wright State University using mice indicate that PAF- and PDT-induced immunosuppression is blocked by treatment with COX-2 inhibitors. This study is conducted as a proof of concept. Study length and visit for subjects with actinic keratoses: The first part of the study is completed in 12 days then there are follow up visits at 6 and 12 months. There are a total of 6 separate visits to the research office. Study length and visit for control subjects: The study is completed in 10 days. There are a total of 4 separate visits to the research office.

NCT ID: NCT03653234 Completed - Clinical trials for Mild Cognitive Impairment

TV-based Service to Support People Living With Mild Dementia or Mild Cognitive Impariment

TV-AssistDem
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This multicentre randomized controlled trial aims to evaluate the effects of an intervention consisting of a TV-based Assistive Integrated Service developed to improve the quality of life in older people with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregivers. This study is a collaboration between four European countries (Spain, Romania, Italy and Switzerland) and the clinical trials will be conducted in two of these countries (Spain and Romania) In total 240 dyads, consisting of a person with mild cognitive impairment or mild dementia and their informal caregiver will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a device with the Tv-AssistDem platform (intervention group). Participants in the trial will be assessed for a period of 12 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PMCI/MD capacity to remain in the study. In the follow up visits, investigators will assess the PMCI/MD quality of life, caregiver's quality of life and burden, patient treatment adherence, patient functional status and service utilization. A user-behaviour analysis and usability evaluation will also be performed.

NCT ID: NCT03658694 Completed - Fibromyalgia Clinical Trials

Repetitive Transcranial Magnetic Stimulation of Relief of Fibromyalgia Pain

TMSFFI
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

There are currently several points concerning rTMS for pain relief that have a huge impact in the practical application of rTMS in clinical practice, but which have not been approached by previous studies. Also, an even more important issue is the frequency of the sessions in each treatment protocol. The idea of performing stimulation in chronic pain patients on a consecutive daily basis for long-term treatments seem unrealistic and potentially costly. However, it has been reported in animals, healthy subjects and FM patients that the analgesic effects of rTMS can outlast the stimulation session for several minutes and even days. This has led to the proposal that pain treatment with rTMS could be performed in consecutive daily induction sessions, followed by spaced (weekly, fortnightly and even monthly) maintenance sessions. This approach is similar to what is performed routinely in patients with major depression treated by rTMS to the dorsolateral prefrontal cortex, and has successfully been tested in FM patients in a single- center study. Should this approach prove effective in larger prospective multicentric studies, rTMS could enter the armamentarium of non-invasive, non- pharmacological, low-adverse event therapeutic options to relieve fibromyalgia- related pain and associate symptoms. Hence, our aim is to conduct a multicentric international clinical trial on the influence of rTMS in the control of pain in a consecutive adaptive trial design where conventional rTMS (10Hz) and patterned rTMS (theta-burst) will be studied. Stimulations will be performed in a clinical practice-friendly approach, where daily maintenance sessions will be followed by weekly, and fortnightly stimulation sessions. There have been very scarce adaptive trials in the pain and non-invasive stimulation fields. This methodological approach allows for the use of lower number of patients in consecutive trials and, among other qualities, it allows for the imputation of data from the first trial into the second one, thus decreasing the duration of the studies and the number of participants.