louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04664166: Alpena Otago Telehealth Program
Official title: Outcomes of Alpena Otago Telehealth Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatrics
Exercise
Telemedicine
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Alpena Senior Citizens Center
First posted: 2020-12-11
Enrollment: 23
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants are residents living in the Alpena county and are representative of the demographics in a rural community in Michigan.

Brief summary: This project is to analyze the outcomes of the Alpena Otago Telehealth Program. The Alpena Senior Citizens Center is implementing the Otago program, an evidence-based, 6-month, home exercise program using live video chats in combination with an online exercise app, Blue Marble. We will recruit seniors who are participants of the Alpena Otago Telehealth Program to allow the study team to analyze their outcomes. The goal of the study is to examine the feasibility and efficacy of a 6-month, home-based, Otago Telehealth program for seniors in Alpena.


Eligibility criteria: Inclusion Criteria:

* participating in Alpena Otago telehealth program
* age \>= 60 years
* ability to use a tablet
* ability to walk at home with or without a cane or walker
* ability to exercise like moving arms or legs while standing
* ability to communicate in English and follow instructions
* ability to provide the consent

Exclusion Criteria:

* advanced neurologic condition
* severe visual impairments
* falls due to syncope or dizziness

Primary outcomes:
measure: Retention rate
timeFrame: 6 months
measure: Fall Risk Questionnaire (FRQ)
timeFrame: 6 months
measure: Activities-specific Balance Scale (ABC)
timeFrame: 6 months
measure: PROMIS Global Health Scale v1.2 (PROMIS)
timeFrame: 6 months
measure: Exercise adherence
timeFrame: 6 months
Secondary outcomes:
measure: 30-Second Chair Stand Test (30CST)
timeFrame: 6 months
measure: Timed Up and Go (TUG)
timeFrame: 6 months
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 6 months
measure: Program acceptance
timeFrame: 6 months
Other outcomes:
Locations:
city: Flint
country: United States
facility: University of Michigan-Flint
state: Michigan
Study officials:
References:
Clinical trial NCT04291066: Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Official title: Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 92
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the administration of N-Acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (\>60 years of age) who have experienced a traumatic brain injury.

Detailed description: This study aims to determine the effect of supplemental N-acetyl cysteine and additional multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms as determined by the Rivermeade Post-concussion Questionnaire (RPQ) within 24 hours of admission, post injury day 7, and post injury day 30. The RPQ questionnaires will be given to patients older than 60 years, who have been evaluated by the HonorHealth John C. Lincoln Medical Center or Deer Valley Medical Center trauma service within 3 hours of sustaining a traumatic brain injury (TBI).

Eligibility criteria: Inclusion Criteria:

* 60 years or older
* present to emergency department within 3 hours of documented TBI

Exclusion Criteria:

* patients without TBI
* patients with a history of TBI greater than 3 hours prior to presentation
* patients under the age of 60
* currently enrolled in an ongoing research study
* patients who at baseline prior to the TBI, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to TBI)
* Patients who are unable to tolerate PO medications within 3 hours of sustaining TBI.

Primary outcomes:
measure: Determine improvement in somatic, cognitive, and emotional post-concussion symptoms as measured by the Rivermeade Post-concussion Questionnaire (RPQ) in treatment group vs non-treatment group.
timeFrame: 1 to 30 days post traumatic brain injury event
Secondary outcomes:
measure: Severity of common post TBI symptoms
timeFrame: 1 to 30 days post traumatic brain injury event
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth John C. Lincoln Medical Center
state: Arizona
city: Phoenix
country: United States
facility: HonorHealth Deer Valley Medical Center
state: Arizona
Study officials:
affiliation: HonorHealth Research Institute
name: Ryab mcPherson, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mcpherson RA, Mangram AJ, Barletta JF, Dzandu JK. N -acetylcysteine is associated with reduction of postconcussive symptoms in elderly patients: A pilot study. J Trauma Acute Care Surg. 2022 Nov 1;93(5):644-649. doi: 10.1097/TA.0000000000003639. Epub 2022 Apr 8.
Clinical trial NCT02733666: Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Official title: Open Reduction and Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Humeral Fractures
Keywords: Absorbable screw
Internal fixation
Children
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 86
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.

Detailed description: Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.

Eligibility criteria: Inclusion Criteria:

All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III

Exclusion Criteria:

participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III

Primary outcomes:
measure: Elbow Motion angle in degree
timeFrame: 6 months after surgery.
measure: Strength in Newton (N)
timeFrame: 6 months after surgery.
measure: stability
timeFrame: 6 months after surgery.
measure: Pain
timeFrame: 6 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05861466: Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A
Official title: Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .

The main question\[s\]it aims to answer are:

•\[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?\] •\[is there any effect of Prior Anterior Chamber Paracentesis?\] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)\& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . \]


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus type II.
* Patients with visual acuity \> 0.1, able to fixate and with clear visual media.
* Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.

Exclusion Criteria:

* Age under 40 years.
* Poorly controlled diabetics (HbA1C greater than 9.0%)
* Proliferative diabetic retinopathy.
* OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
* Neovascular AMD in the study eye.
* History of glaucoma.
* Tilted disc and optic disc anomalies.
* One-eyed patients.
* Usage of systemic or topical corticosteroids.
* Patients with a history of intraocular surgery other than cataract surgery.
* Systemc diseases rather than hypertension and diabetes mellitus.
* Corneal opacities that might hinder acquisition of good quality OCT images.

Primary outcomes:
measure: the acute change in angiographic parameters
timeFrame: 1 day
Secondary outcomes:
measure: the acute change in intra-ocular pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
Clinical trial NCT04787666: Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery
Official title: Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery

Detailed description: The study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. It assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.The study will be randomized, single-center, prospective.

Eligibility criteria: Inclusion Criteria:

1. Age from 30 years to 60 years inclusive
2. Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)
3. By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)
4. Consent the patient to participate in this study

Exclusion Criteria:

1. Tracheal intubation, absence of independent breathing
2. Unstable hemodynamics or hemodynamically significant rhythm disturbances
3. Acute violation of the cerebral blood supply
4. Shocks of various etiologies
5. Impossibility provide respiratory protection , high risk of aspiration
6. Lack of productive contact with the patient
7. Patient's refusal to participate in this study

Primary outcomes:
measure: PaO2/FiO2 more than 300
timeFrame: hospitalisation period, an average of 1 week
Secondary outcomes:
measure: arterial blood oxygenation level
timeFrame: hospitalisation period, an average of 1 week
measure: maximum inspiratory volume
timeFrame: hospitalisation period, an average of 1 week
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Centre of Surgery
Study officials:
affiliation: Head of the Intensive Care Unit
name: Alexander A. Eremenko, prof
role: STUDY_DIRECTOR
affiliation: anesthesiologist-resuscitator
name: Darya V. Ryabova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02152566: Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Official title: Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Disordered Breathing
Congestive Heart Failure
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.

The purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen.

Heart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. This sleep study may be completed in the sleep laboratory (attended polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.


Eligibility criteria: Inclusion Criteria:

* Men and Women aged ≥ 18 years
* Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months
* Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit.
* New York Heart Association Class II or III after optimization of medical therapy
* Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry

Exclusion Criteria:

* Unstable angina
* Myocardial infarction within the last 12 months
* Cardiac surgery within the previous 6 months
* Pregnancy
* Unwilling or unable to provide informed consent
* Uncontrolled arrhythmias
* Severe valvular heart disease
* Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion.

Primary outcomes:
measure: Treatment Efficacy
timeFrame: During 1 night of Sleep on PSG
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare Ltd.
state: East Tamaki
city: Auckland
country: New Zealand
facility: Middlemore Hospital
state: Otahuhu
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Rachel Vicars, PhD - Eng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06304766: Open Versus Laparoscopic Ablation of Liver Malignancies
Official title: Laparoscopic Versus Open Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Liver Metastases
Keywords: Laparoscopic ablation
Open ablation
Complications
Ablation response
Quality of life
Randomized
Multicenter
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.

Detailed description: Liver malignancies is a major cause of cancer-related mortality and the incidence is increasing. Patients with liver malignancies are often left with limited surgical treatment options due to extensive tumor burden or comorbidities. Ablation is a less invasive treatment for these patients that can be performed percutaneously, by laparoscopy or open surgery. Ablation during open surgery has a high potential of complications. Laparoscopic ablation presumably has a lower complication rate than during open surgery, yet still offers some of the same advantages needed for tumors in locations not favorable for percutaneous ablation. This study aims to compare laparoscopic ablation with ablation during open surgery to investigate a treatment option with a supposed lower complication rate and equally treatment effectiveness after one month.

Eligibility criteria: Inclusion Criteria:

* One or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment.

Exclusion Criteria:

* Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.

Primary outcomes:
measure: Complications measured by the comprehensive complication index.
timeFrame: Complications are registered and clavien-dindo graded 30 days after surgery.
Secondary outcomes:
measure: Tumor ablation completeness.
timeFrame: 30 days after surgery.
measure: Quality of Recovery score (QoR)
timeFrame: Before surgery and postoperative day 1, 7 and 30.
measure: Quality of Life score (QoL)
timeFrame: Before surgery and on postoperative day 30.
measure: Overall survival
timeFrame: Up to 90 days after surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Hans-Christian Pommergaard, MD DMSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04129866: Mobile Interpretation Bias Modification Clinical Trial
Official title: Mobile Interpretation Bias Modification Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Sensitivity
Suicidal Ideation
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
Collaborators: name: Military Suicide Research Consortium
First posted: 2019-10-17
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Mobile-Interpretation Bias Modification clinical trial aims to examine the efficacy of a brief mobile phone delivered interpretation bias modification to reduce anxiety sensitivity cognitive concerns and suicidal ideation in National Guard Personnel. The investigators propose a randomized controlled trial testing the efficacy, acceptability, and usability of M-IBM with a sample of 114 National Guardsmen with current suicidal ideation and elevated anxiety sensitivity cognitive concerns. Participants will complete assessments, receive assistance on installing M- IBM on their phone, complete an M-IBM intervention session, and complete post-intervention assessments. Baseline measures of psychopathology, and usability/acceptability of M-IBM will be obtained during the initial session. In addition, 1-month, and 3-month follow-ups would be scheduled to examine changes in psychopathology. The investigators hypothesize that those randomized to M-IBM will experience reductions in anxiety sensitivity cognitive concerns, suicidal ideation. In addition participants will find M-IBM acceptable and easy to use.


Eligibility criteria: Inclusion Criteria:

* Elevated ASCC (\>2) and include only Guard members who also have current SI (\> 0) .
* Ownership of a smartphone

Exclusion Criteria:

* those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services

Primary outcomes:
measure: Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
timeFrame: 30 minutes
measure: Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
timeFrame: 1 month post intervention
measure: Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
timeFrame: 3 months post intervention
measure: The Self-Injurious Thoughts and Behaviors Interview
timeFrame: 1 month post intervention
measure: The Self-Injurious Thoughts and Behaviors Interview
timeFrame: 3 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: University of Southern Mississippi
state: Mississippi
Study officials:
References: