louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03194841: Heart Failure Self-care With the Aid of a Smartphone Application
Official title: Heart Failure Self-care With the Aid of a Smartphone Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with individuals with HF living at home. For the purpose of this study, smart phone communication was utilized. Smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. Using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. This study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.


Eligibility criteria: Inclusion Criteria:

* living in a non-nursing home setting
* primary providers of own self-care
* established diagnosis of heart failure
* cognitively intact
* able to speak/write English

Exclusion Criteria:

* not willing to use a smartphone
* not exhibiting acute decompensated heart failure symptoms

Primary outcomes:
measure: Self-Care of Heart Failure Index (SCHFI)
timeFrame: two weeks
Secondary outcomes:
measure: Heart Failure Somatic Awareness Scale
timeFrame: two weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Massachusetts Dartmouth
name: Kristen Sethares, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04955041: Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy
Official title: Effectiveness of T2* MRI in Predicting Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spondylotic Myelopathy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients came from Peking University Third Hospital

Brief summary: Utilization of T2\* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)

Detailed description: Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal \[ISI\]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein.

A new biomarker, T2\* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2\* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.

Eligibility criteria: Inclusion Criteria:

* diagnosed with CSM and operated on by one senior orthopedist
* available preoperative MRI results
* high-quality image data with no motion artifacts
* available preoperative and long-term follow-up (≥1 years) mJOA score

Exclusion Criteria:

* prior head or neck surgery
* a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).

Primary outcomes:
measure: Improvement of neurologic function
timeFrame: at follow-up time (≥1 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Huishu Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05991141: Could Apnea Induce Hypoalgesia?
Official title: Could Apnea Induce Hypoalgesia? An Explorative Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Apnea
Keywords: Pain
Apnoea
Apnea
Hypoalgesia
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts, Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.

Detailed description: A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* 18-30 years
* Currently pain-free
* Basal SpO2 ≥95%

Exclusion Criteria:

* Diabetes diagnosis
* Hypertension or hypotension diagnosis
* Pharmacological treatment
* Frequent pain during last month
* Drug consumption
* Self-harming behaviours
* Pregnant or potentially pregnant
* Cardiac or respiratory pathology
* Splenectomy or spleen disease
* Having performed moderate or high intensity physical activity 24 hours prior to the study
* Not having slept the previous night
* Alcohol intake 24 hours prior to study.

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: Before and immediately after the interventions
Secondary outcomes:
measure: Conditioned pain modulation
timeFrame: Before and immediately after the interventions
measure: Heart Rate and Oxygen Saturation
timeFrame: During the intervention and for 2 minutes additionally after the end of the intervention
measure: Rated Perceived Exertion
timeFrame: This outcome was assessed immediately after having finished the intervention protocols
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Superior de Estudios La Salle
Study officials:
affiliation: CSEULaSalle
name: José Fierro Marrero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329341: Service Dogs for Veterans With PTSD
Official title: Service Dogs for Veterans With PTSD: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Service Dogs
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Referral from provider.
* PTSD diagnosis
* In active treatment for PTSD for at least three months at time of enrollment, with plans to remain in active treatment
* Acceptance by the dog vendor for the service dog
* Ability to adequately care for a dog - physically/financially
* Able to travel to vendor for pairing with dog

Exclusion Criteria:

* Been hospitalized for mental health reasons in the prior 6 months
* Not living at the same residence for 6 months.
* Diagnoses: Psychoses, Delusions, dementia, active alcohol/substance dependence. Moderate to severe TBI. Any other diagnosis deemed by PI to limit ability to participate or give informed consent
* At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study.
* Children under age 10 living in the home

Primary outcomes:
measure: Mental Health Outcomes
timeFrame: 3,6,9,12,18 and 24 months after receipt of service dog
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Stephanie McGovern, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244619: PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Official title: Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-op Pain
Keywords: Hip replacement
Knee replacement
randomized trial
acetaminophen
post-op pain management
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Detailed description: Subjects will be randomized to receive perioperative dosing of either:

1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,
2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).

Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Able to provide written consent
* Able to read and write in English
* Weighing over 50 kg
* Will undergo total hip or total knee joint replacement

Exclusion Criteria:

* Non-verbal patients
* Unable to use numeric pain scale
* Allergic to the test article
* Documented hepatic impairment or failure
* Current illicit drug use
* Requires traumatic or emergent surgery
* Pregnant women
* Women who are breastfeeding
* Prisoners
* Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
* Unable to swallow oral capsules

Primary outcomes:
measure: Total Post-operative Use of Opioids
timeFrame: During post-op period up to 24 hrs after surgery
Secondary outcomes:
measure: Patient-rated Pain in the Post-operative Period
timeFrame: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
Other outcomes:
measure: Post-operative Nausea and Vomiting
timeFrame: During post-op period up to 24 hrs after surgery
measure: Time to First Ambulation - 10 Feet
timeFrame: During post-op period up to 24 hours after surgery
measure: Time to First Rescue Opioid (PRN Order)
timeFrame: During post-op period up to 24 hrs after surgery
Locations:
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Sidney (Skip) Hickman, RPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751319: Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department
Official title: Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Patient Admission
Hospital Readmission
Length of Stay
Fall
Quality of Life
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: City of Espoo
name: University of Helsinki
First posted: 2018-11-23
Enrollment: 432
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of frailty-related problems and includes individualized treatment plan with multi-discipline supportive and treating measures for the older frailty patients. However, there is limited evidence of feasibility and efficacy of the CGA when provided in the emergency department setting.

In the GAOPS-study the efficacy of the CGA in emergency department setting will be studied by randomized controlled study protocol. We aim to study if the CGA provided in the ED is feasible, safe and efficient method when added with standard emergency care for older frail patients.


Eligibility criteria: Inclusion Criteria:

* Age of minimum 75 years
* "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse

Exclusion Criteria:

* Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.

Primary outcomes:
measure: Cumulated Length of Stay
timeFrame: Day 365
Secondary outcomes:
measure: Admissions
timeFrame: Day 30, Day 365
measure: Admission rate
timeFrame: Day 0
measure: Readmissions in the ED
timeFrame: Hour 72, Day 30, Day 365
measure: Living at home
timeFrame: Day 365
measure: Quality of Life
timeFrame: Day 0, Day 365
Other outcomes:
measure: Length-of-Stay in the ED
timeFrame: Day 0
measure: Length-of-Stay in the ward
timeFrame: Day 365
measure: Mortality
timeFrame: Day 365
measure: Falls
timeFrame: Day 365
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital, Jorvi ED
state: Uusimaa
Study officials:
affiliation: Department of Emergency Medicine and Services, Helsinki University Hospital
name: Veli-Pekka Harjola
role: STUDY_DIRECTOR
affiliation: Department of Emergency Medicine and Services, Helsinki University Hospital
name: Janne Alakare, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alakare J, Kemp K, Strandberg T, Castren M, Jakovljevic D, Tolonen J, Harjola VP. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr. 2021 Jul 2;21(1):408. doi: 10.1186/s12877-021-02351-2.
Clinical trial NCT03703219: Impact of Mothers Touch Program on Women's Psychological Functioning
Official title: The Role of Indian Post-partum Care in Women's Psychological Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Distress
Post Partum Depression
Mood
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Mothers Touch Foundation, India
First posted: 2018-10-11
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants giving birth in pre selected 4 hospitals in India.

Brief summary: The study investigates the effect of the Mothers Touch program on the psychological well-being of new mothers following 5 weeks of child birth. Mothers Touch Program is designed based on traditional Indian post-partum care given by trained carer in the family.

Study was designed as cohort, including a randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* Healthy women giving birth for first time (primiparous)
* Given informed consent
* Accepts traditional home care

Exclusion Criteria:

* Previous history of mental health condition
* History drug or substance abuse

Primary outcomes:
measure: Post Natal Depression
timeFrame: 6 weeks following child birth
Secondary outcomes:
measure: General well being
timeFrame: 6 weeks following child birth
measure: Parent-Infant Relationship
timeFrame: 6 weeks following child birth
measure: Maternal Confidence
timeFrame: 6 weeks following child birth
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Reserach Institute
state: Rajasthan
Study officials:
affiliation: Mothers Touch Foundation, India
name: Rekha Chaudhari
role: STUDY_CHAIR
affiliation: Warwick Research Services
name: Neha Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Mothers Touch Foundation, India
name: Sangram Birje
role: STUDY_DIRECTOR
affiliation: Mothers Touch Foundation, India
name: Aparna Chaudhari
role: STUDY_DIRECTOR
References:
Clinical trial NCT06638619: Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia
Official title: Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia: A Comprehensive Eye Movement Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemianopia, Homonymous
Keywords: stroke
vision
hemianopia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study will look at how eye movements and reading performance change after training. Researchers will compare the results of two groups: one group will complete five clinical training sessions using an eye-tracking machine for 30 minutes each, while the other group will do at-home reading exercises for 20 minutes a day, 5 days a week, for 6 weeks. The goal is to see if there is a difference in performance between the two types of training.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke
* Presence of hemianopia with central vision involvement
* Stroke occurred at least 6-months before enrollment

Exclusion Criteria:

* Presence of hemianopia with macular sparing
* Diagnosis of hemispatial neglect

Primary outcomes:
measure: Oculomotor Metrics
timeFrame: Pre-training and at 6-weeks.
Secondary outcomes:
measure: Pepper Visual Skills Reading Test (VSRST)
timeFrame: Pre-training and at 6-weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Jason Vice, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03925519: Exercise as Cardio Protective Modulates in Diabetic Patients
Official title: Supervised Aerobic Exercise as Anti-adiposity and Cardioprotective Modulates in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Exercise
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty subjects diagnosed with type 2 diabetes for more than 5 years aged 45-70 years were invited in the period from 2013 to 2014 to participate in this study. Patients were diagnosed according to the criteria of American diabetes association.32 Based on the values of BMI, the patients were classified into two groups, obese diabetic group (n= 25, BMI ≥ 30 kg/m2) and non-obese group (n= 25, BMI ≤ 30 kg/m2).

Brief summary: * Physical exercise for 6 months produced significant improvement in adiponectin, hs-CRP, and nitric oxide (NO) and was significantly correlated with adiposity markers, lipid profile and glycemic control factors in both obese and non-obese diabetic patients.
* Patients with good physical activity reported a significant decrease in BMI, CHD risk scores, reduced hs-CRP, an increase in the levels of adiponectin and nitric oxide.
* In patients with type 2 diabetes mellitus, adiposity markers, lipid profile, hs-CRP, and adiponectin were significantly improved following moderate exercise interventions

Detailed description: To elucidate the potential role of exercise as anti-adiposity and anti-cardio protective modulates, we thought to investigate the effect of supervised aerobic training of moderate intensity on adiposity markers, nitric oxide level, plasma adiponectin, hs-CRP, and its association with CHD risk score in obese and non-obese patients with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* patients with type 2 diabetes for more than 5 years.
* Patients who were diagnosed according to the criteria of the American diabetes association.
* Not receiving any drugs affecting the data obtained
* had Normal daily diets
* Not participating in any other exercise programs
* Without any musculoskeletal disorders affecting an exercise program

Exclusion Criteria:

* Exclusion criteria included anemia, overt complications of diabetes like nephropathy, neuropathy, retinopathy, obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities), HCV, HBV, chronic liver and kidney diseases, hypothyroidism, and drugs (diuretics; oral contraceptives).

Primary outcomes:
measure: Estimation of coronary heart disease risk score
timeFrame: six months
measure: Analysis of blood sugar, glycated hemoglobin (HbA1c)
timeFrame: six months
Secondary outcomes:
measure: Analysis of Nitric Oxide
timeFrame: six months
Other outcomes:
Locations:
Study officials:
References: