louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01565642: Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
Official title: Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia, decision making
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-03-28
Enrollment: 302
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.


Eligibility criteria: Inclusion Criteria:

* Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia

Exclusion Criteria:

* Non-related legal surrogate without personal knowledge of resident

Primary outcomes:
measure: Quality of Communication and Decision-making
timeFrame: 3 months
Secondary outcomes:
measure: Number of Palliative Care Domains in Care Plan
timeFrame: 9 months
measure: Satisfaction With Care
timeFrame: 9 months
measure: Comfort in Dying
timeFrame: 9 months
measure: Alzheimer Disease Related Quality of Life
timeFrame: 9 months
measure: Quality of Dying
timeFrame: 9 months
measure: Frequency of Communication
timeFrame: 9 months
measure: Hospice Referral
timeFrame: 9 months
measure: Hospitalizations
timeFrame: 9 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura C Hanson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ernecoff NC, Zimmerman S, Mitchell SL, Song MK, Lin FC, Wessell KL, Hanson LC. Concordance between Goals of Care and Treatment Decisions for Persons with Dementia. J Palliat Med. 2018 Oct;21(10):1442-1447. doi: 10.1089/jpm.2018.0103. Epub 2018 Jun 29.
citation: Hanson LC, Zimmerman S, Song MK, Lin FC, Rosemond C, Carey TS, Mitchell SL. Effect of the Goals of Care Intervention for Advanced Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jan 1;177(1):24-31. doi: 10.1001/jamainternmed.2016.7031.
citation: Hanson LC, Song MK, Zimmerman S, Gilliam R, Rosemond C, Chisholm L, Lin FC. Fidelity to a behavioral intervention to improve goals of care decisions for nursing home residents with advanced dementia. Clin Trials. 2016 Dec;13(6):599-604. doi: 10.1177/1740774516650863. Epub 2016 Jun 7.
Clinical trial NCT03535142: Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Official title: Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Metabolic Encephalopathy
Obesity, Morbid
Non-alcoholic Steatohepatitis
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Odense University Hospital
name: Esbjerg University Hospital of South-West Jutland
First posted: 2018-05-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective non-randomized intervention case control study on patients with a BMI \> 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.


Eligibility criteria: Inclusion Criteria case group:

* Age \> 18 years
* BMI \>35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
* Able to give written informed consent.

Inclusion criteria control group:

* Age \> 18 years
* BMI \>35 kg/m2 with no wish to undergo bariatric surgery.
* Able to give written informed consent.

Exclusion Criteria:

* Active viral hepatitis
* Not willing or able to consent
* Contraindications to liver biopsy

Primary outcomes:
measure: Number of participants who will die during the follow up period in case and control group
timeFrame: 10 years follow up after inclusion
Secondary outcomes:
measure: Number of participant who will experience progressive fatty liver disease in case and control group
timeFrame: 10 years follow up after inclusion
measure: Change in continuous reaction time measurement after bariatric surgery
timeFrame: 10 years follow up after inclusion
measure: Change in EEG after bariatric surgery
timeFrame: 24 months after surgery
measure: Change in intelligence quotient after bariatric surgery
timeFrame: 24 months efter surgery
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Jutland
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Mette M Lauridsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385642: Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee
Official title: Follow-Up Study Evaluating the Long-Term Outcomes of ChondroMimetic in the Treatment of Osteochondral Defects (Extension Study of Protocol 0MCM0107)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteochondral Defect
Lead sponsor: Collagen Solutions
Sponsor class: INDUSTRY
First posted: 2017-12-28
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects were treated with a Chondromimetic device under Protocol 0MCM0107

Brief summary: To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.

Detailed description: This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.

Eligibility criteria: Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.

Primary outcomes:
measure: Change from 0MCM0107 baseline in Modified Cincinnati Rating System
timeFrame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
measure: KOOS (Knee injury and Osteoarthritis Outcome Score
timeFrame: Through study completion, an average of approximately 8 years follow-up
measure: Cartilage repair tissue quantity and quality using 3D quantitative MRI analysis
timeFrame: Through study completion, an average of approximately 8 years follow-up
measure: Osteochondral defect repair assessment
timeFrame: Through study completion, an average of approximately 8 years follow-up
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 0MCM0107 Baseline and through study completion, an average of approximately 8 years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Uzsoki Hospital
Study officials:
affiliation: Uzsoki Hospital
name: Laszlo Hangody, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06946342: WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life
Official title: "Efficacy of the WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life in Sedentary Overweight and Obese Middle-Aged Women: A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Obesity
Sedentary Behavior
Keywords: Hydrotherapy
Exercise Therapy
Middle Aged
Quality of Life
Disability Evaluation
Lead sponsor: University of Sistan and Baluchestan
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, randomized, single-blind, parallel-group trial comparing the efficacy of two distinct exercise interventions:

Experimental Arm: Structured aquatic exercise program (WATERinMOTION).

Active Comparator Arm: Land-based rehabilitation program.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial compares the efficacy of an 8-week WATERinMOTION aquatic exercise program versus land-based rehabilitation for reducing low-back pain (LBP) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). Outcomes include pain intensity (VAS), functional disability (ODI), and health-related quality of life (SF-36).

Detailed description: Participants (aged 45-65, BMI ≥25 kg/m², chronic LBP ≥3 months) were randomized to aquatic exercise (n=45) or land-based rehabilitation (n=45). Both groups completed three 60-minute sessions/week for 8 weeks. Assessments occurred at baseline, post-intervention, and 3-month follow-up. Primary outcomes: VAS and ODI; secondary outcomes: SF-36 and satisfaction.

Eligibility criteria: Inclusion Criteria:

* Women aged 45-65, BMI ≥25 kg/m².
* Sedentary (\<150 min/week moderate activity).
* Chronic LBP (≥3 months, VAS ≥4).

Exclusion Criteria:

* Contraindications to exercise (e.g., severe cardiovascular disease).
* Spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline, 8 weeks (post-intervention), 3-month follow-up
measure: Functional Disability
timeFrame: Baseline, 8 weeks (post-intervention), 3-month follow-up
Secondary outcomes:
measure: Health-Related Quality of Life (HRQoL)
timeFrame: Baseline, 8 weeks (post-intervention), 3-month follow-up
measure: Participant Satisfaction
timeFrame: 8 weeks (post-intervention), 3-month follow-up
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Sport Sciences Department
state: Sistan And Baluchestan
Study officials:
affiliation: Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran
name: Mohammadreza Rezaeipour, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03467542: PHIL in the Treatment of Intracranial dAVF.
Official title: PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Dural Fistula
Keywords: Fistula
Intracranial
Dural
Arteriovenous
Liquid Embolic
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 64
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.


Eligibility criteria: Inclusion Criteria:

* Age 22 - 80 years.
* Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
* Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
* Subject has an intracranial dAVF

Exclusion Criteria:

* Subject having multiple dAVFs to be treated.
* Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
* Subject has known allergies to dimethylsulfoxide, iodine.
* Subject is currently participating in another clinical study
* Female subject is currently pregnant.
* Subject has co-morbid conditions that may limit survival to less than 24 months.

Primary outcomes:
measure: Subjects With Neurological Death or Ipsilateral Stroke
timeFrame: 30 days
Secondary outcomes:
measure: Technical Events During the PHIL Embolization Procedure(s)
timeFrame: During the procedure
measure: Device-related Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Mt. Sinai
name: J Mocco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany Medical College
name: Alan Boulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05832242: Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
Official title: Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diverticulitis
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult emergency department patients suspected of having diverticulitis.

Brief summary: The purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. The accuracy of the decision tool will be evaluated. This study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis


Eligibility criteria: Inclusion Criteria:

* Emergency department patient
* Provider suspicion of diverticulitis
* CT scan ordered

Exclusion Criteria:

* Pregnant patient
* Prisoner
* Non-English speaking
* Inability to provide informed consent
* Hemodynamically unstable as determined by provider
* Previous abdominal surgery within last 7 days
* Unable to lay flat for ultrasound exam

Primary outcomes:
measure: Simple Diverticulitis
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Allison Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04445142: Fovea ERM After Fovea-sparing ILM Peeling
Official title: Severe Foveal Epiretinal Membrane Contraction After Previous Fovea-sparing Internal Limiting Membrane Peeling Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Internal Limiting Membrane Wrinkling
Keywords: Fovea-sparing internal limiting membrane peeling
Epiretinal membrane.
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery

Brief summary: To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction

Detailed description: Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on residual internal limiting membrane (ILM) with severe contraction after previous fovea-sparing internal limiting membrane (ILM) peeling.

Study design: Retrospective case series Methods: We report patients who previously received fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.

Eligibility criteria: Inclusion Criteria:

* patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery

Exclusion Criteria:

* patients who did not receive previous fovea-sparing internal limiting membrane surgery

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
measure: Optical coherence tomography finding
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Department of ophthalmology, Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: San-Ni Chen, MD
role: STUDY_CHAIR
References:
citation: Chen YC, Chen SN. Isolated Central Epiretinal Membrane: A Rare Complication of Fovea-Sparing Internal Limiting Membrane Peeling Technique. J Ophthalmol. 2021 Apr 14;2021:6654604. doi: 10.1155/2021/6654604. eCollection 2021.
Clinical trial NCT01052142: Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma
Official title: A Phase I Open-label Study of the Safety and Immunogenicity of Escalating Doses of Lipovaxin-MM, a Novel Melanoma Immunotherapeutic, in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Keywords: Melanoma
Cancer vaccines
Lead sponsor: Lipotek Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Royal Adelaide Hospital
name: Trident Clinical Research Pty Ltd
First posted: 2010-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.


Eligibility criteria: Key Inclusion Criteria:

* Patients with incurable stage IV malignant melanoma for which no standard or curative therapy exist OR patients locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option.
* Must be able and willing to provide written informed consent.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Life expectancy of ≥12 weeks.
* Female subjects must be of non-child-bearing potential or using appropriate contraception.
* Positive test for cell mediated immunity.

Key Exclusion Criteria:

* Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks.
* Previous immunotherapy (except IL-2 or interferon-based therapy) for melanoma.
* Inadequate bone marrow reserve.
* Serum bilirubin ≥1.2 times the upper limit of normal.
* In absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal.
* If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable.
* Inadequate renal function.
* Evidence of severe or uncontrolled systemic diseases.
* Unresolved toxicity ≥CTC Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
* Participation in a trial of an investigational agent within the prior 30 days.
* HIV infection.
* Immunosuppressive therapy including corticosteroids within 4 weeks of screening.
* Pregnant or breast-feeding females.

Primary outcomes:
measure: Adverse events
timeFrame: Within 84 days after first dose
measure: Immunogenicity
timeFrame: Within 42 days of first dose
Secondary outcomes:
measure: Anti-cancer activity (RECIST criteria)
timeFrame: Within 84 days of first dose
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Pain & Anaesthesia Research Clinic
state: South Australia
Study officials:
affiliation: Royal Adelaide Hospital Cancer Centre
name: Michael Brown, MBBS FRACP FRCPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02743442: Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pituitary Neoplasms
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-04-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. For many years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale, California, USA) has been greatly developed, especially in urology and gynecology.

Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective.

A robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome.

The investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17).

In this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da Vinci robot in patients with pituitary adenoma.


Eligibility criteria: Inclusion Criteria:

* Pituitary adenoma with a surgical indication : visual compression and chiasmal syndrome, intracranial hypertension , hormonal syndrome (hypopituitarism and hypersecretion ) , failure of medicamentous treatments for prolactinoma
* No pituitary apoplexy (requiring emergency surgery)
* Spontaneous oral opening greater than 35 mm

Exclusion Criteria:

* Insufficient buccal opening
* Intercurrent pathology of oropharyngeal and nasopharyngeal
* Complicated forms of adenoma pituitary adenoma (invasive adenoma)
* Hemostasis disorder
* Phlebitis or active pulmonary embolism

Primary outcomes:
measure: Number of Patients Operated Via da Vinci Robot
timeFrame: 1 day
Secondary outcomes:
measure: Duration of Surgery
timeFrame: 3 hours
measure: Number of Severe Adverse Events
timeFrame: 6 months
measure: Duration of Hospitalization
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References: