louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06466083: Correlation Analysis of POD and pNCD in Elderly Spinal Surgery Patients
Official title: Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Spinal Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Delirium
Postoperative Neurocognitive Disorder
Spinal Surgery
Keywords: postoperative delirium
postoperative neurocognitive disorder
serum indexes
spinal surgery
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 165
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 65\~100 years of age who have undergone spinal surgical anesthesia

Brief summary: This study is a prospective cohort study to investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Detailed description: To investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Neurocognitive function of the study participants was assessed within one week before surgery using the Montreal Cognitive Assessment (MoCA). Compare changes in serum indexes level before and after surgery. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. Neurocognitive function assessments were conducted long-term after surgery for the POD group to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups, followed by serum indexes.By comparing the changes of serum indexes before and after surgery between the pNCD and non-pNCD subgroups, exploring the correlation of POD and pNCD.

Eligibility criteria: Inclusion Criteria:

* Patients ≥65 years of age who have undergone spinal surgery anesthesia; Sign informed consent

Exclusion Criteria:

* Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases

Primary outcomes:
measure: change in serum indexes between elderly spinal patients with postoperative delirium(POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery
timeFrame: 2024.5.9-2026.5.1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University, Beijing, 100053
Study officials:
References:
Clinical trial NCT04956783: Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
Official title: Comparison of the Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient (over the age of 18) from Montpellier University Hospital or Montpellier Cancer Institute who has initiated an immunotherapy between 01/01/2019 and 31/12/2020 with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab)

Brief summary: This is a retrospective evaluation of the impact of a double dose regimen of immunotherapy use in cancer treatment compared to the single-dose regimen on the occurrence of clinically significant adverse events.

The aim of this study is to provide evidence-based arguments to help clinicians to propose the best treatment regimen for each patient.


Eligibility criteria: Inclusion criteria:

- Any adult patient with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy

Exclusion criteria:

- age \< 18

Primary outcomes:
measure: To compare the incidence of clinical significant toxicities
timeFrame: 18 months
Secondary outcomes:
measure: To describe the incidence
timeFrame: 18 months
measure: To identify risk factors for the development of severe toxicity
timeFrame: 18 months
measure: To describe the management and evolution of toxicities
timeFrame: 18 months
measure: To describe the clinical oncologic response
timeFrame: 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Alexandre Maria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01970683: Probiotics and Recovery From Surgery
Official title: Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Abdominal Operation
Lead sponsor: Catholic Health Initiatives
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.

Detailed description: Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* All elective major GI surgical patients

Exclusion Criteria:

* • Current episode of acute pancreatitis as defined by clinician

  * Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.

Primary outcomes:
measure: 30-day postsurgical outcome including death, infection, readmission
timeFrame: within 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Mercy Medical Center-Des Moines
state: Iowa
Study officials:
References:
citation: Franko J, Raman S, Krishnan N, Frankova D, Tee MC, Brahmbhatt R, Goldman CD, Weigel RJ. Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation. J Am Coll Surg. 2019 Dec;229(6):533-540.e1. doi: 10.1016/j.jamcollsurg.2019.09.002. Epub 2019 Sep 25.
Clinical trial NCT06850883: A Simulation Training Program for Person-Centered In-Home Dementia Care
Official title: A Simulation Training Program for Person-Centered In-Home Dementia Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study primarily explores the impact of a person-centered dementia home care scenario-based training program on home care workers' empathy, care preparedness, competence, predictability, and rewards.


Eligibility criteria: Inclusion Criteria:

(A) Aged 20 years or older; (B) Employed as a full-time worker in a home-based long-term care service institution; (C) Willing to participate in this study.

Exclusion Criteria:

* Employed as a part-time worker in a home-based long-term care service institution

Primary outcomes:
measure: Empathy Level in Formal Caregivers
timeFrame: pretest, Immediately after intervention, 1 month after intervention completion
measure: Preparedness Level in Formal Caregivers
timeFrame: pretest, Immediately after intervention, 1 month after intervention completion
measure: Competence Level in Formal Caregivers
timeFrame: pretest, Immediately after intervention, 1 month after intervention completion
measure: Predictability Level in Formal Caregivers
timeFrame: pretest, Immediately after intervention, 1 month after intervention completion
measure: Rewards Level in Formal Caregivers
timeFrame: pretest, Immediately after intervention, 1 month after intervention completion
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
References:
Clinical trial NCT02442583: Reducing Sedentary Behaviors Among Colorectal Cancer Survivors
Official title: Reducing Sedentary Behaviors Among Colorectal Cancer Survivors: Cancer Survivorship Center Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
survivor
exercise
physical activity
sedentary
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interview colorectal cancer survivors and use this input to create a brochure intended to guide reduction of sedentary behaviors in this population. Have colorectal cancer survivors review and comment on a draft of the brochure. A third group of colorectal cancer survivors will wear an Actigraph activity monitor for one week, then receive feedback on their activity level with the brochure. After one month this group will be surveyed by telephone regarding their use of the brochure, and their physical activity level.


Eligibility criteria: Inclusion Criteria:

* Adult
* Early (stage 1 or 2) colorectal cancer
* 6 months or greater post treatment
* Does not follow guidelines for physical activity
* Average at least 6 hours a day of sedentary behaviors

Exclusion Criteria:

-

Primary outcomes:
measure: Feasibility of the print brochure, as measured by Likert scale.
timeFrame: Baseline
measure: Change in number of minutes per day of light to strenuous physical activity.
timeFrame: Baseline and 1 month
measure: Change in number of minutes per day of bouts of sedentary behaviors.
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Isaac Lipkus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241083: The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Cancer
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.


Eligibility criteria: Inclusion Criteria:

* head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap

Exclusion Criteria:

* Patients having contraindications for the operation.
* Patient refusal to participate in the study

Primary outcomes:
measure: Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: P.O. Box 2000
Study officials:
References:
Clinical trial NCT01549483: Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR)
Official title: Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Airway Hyperresponsiveness
Keywords: asthma
airway hyperresponsiveness
asymptomatic airway hyperresponsiveness
small airways
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patient clinic

Brief summary: The purpose of this study is to study differences in small airways (\<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.


Eligibility criteria: Inclusion criteria for asymptomatic subjects with airway hyperresponsiveness (AHR) :

* Age between 18 and 65 years.
* Forced expiratory volume in one second (FEV1) \> 80% predicted post bronchodilator.
* Provocative concentration causing a 205 fall in FEV1 (PC20) methacholine \<8 mg/ml.
* No history of asthma or previous use of asthma medication.

Inclusion criteria for asymptomatic subjects without AHR :

* Age between 18 and 65 years.
* FEV1 \> 80% predicted post bronchodilator.
* PC20 methacholine \>8 mg/ml.
* No history of asthma or previous use of asthma medication.

Inclusion criteria for patients with asthma:

* Age between 18 and 65 years.
* FEV1 \> 80% predicted.
* PC20 methacholine ≤8 mg/ml.
* Doctor's diagnosis of asthma.
* No history of Chronic obstructive pulmonary disease (COPD).

Exclusion Criteria:

* Use of inhaled or oral steroids, antihistamines, nedocromil, theophylline, leukotrien antagonists or long-acting beta-agonists for at least three weeks before the start of the study.
* Any disease that may affect the outcome of the study as judged by the Investigator.
* FEV1 \<1.2 liter.

Primary outcomes:
measure: Peripheral airway resistance measured with impulse oscillometry (IOS)
timeFrame: visit 1
Secondary outcomes:
measure: Small airway parameters
timeFrame: visit 1
measure: mRNA expression in nasal epithelium
timeFrame: visit 2
measure: Peripheral airway resistance measured during provocation test
timeFrame: visit 2
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Maarten Van den Berge, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764283: The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
Official title: The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Three types of dressing will be compared to prevent postoperative epidural catheter migration. Patients will be randomised to have a Tegaderm dressing, an Epi-fix dressing or a Lockit-Plus dressing to secure the epidural catheter for postoperative analgesia. The length of the epidural catheter visible at the patient's skin surface will be recorded after insertion and every day until removal. The integrity of the dressing and problems with analgesia will also be recorded.


Eligibility criteria: Inclusion Criteria:

* All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent
* 18 years or older

Exclusion Criteria:

* Patients who did not sign an informed consent

Primary outcomes:
measure: Epidural catheter migration from insertion till removal
timeFrame: Until removal of the epidural catheter
Secondary outcomes:
measure: Problems of analgesia during Patient Controlled Epidural Analgesia
timeFrame: Until removal of the epidural catheter
measure: Body Mass Index
timeFrame: Until removal of the epidural catheter
measure: The integrity of the dressing
timeFrame: Until removal of the epidural catheter
measure: The comfort of the dressing
timeFrame: Until removal of the epidural catheter
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares Ghent
Study officials:
affiliation: University Ghent
name: Eric Mortier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00050583: Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
Official title: Treatment of Somatization in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Somatoform Disorders
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Rutgers, The State University of New Jersey
First posted: 2002-12-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.

Detailed description: Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.

Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Somatization disorder

Exclusion Criteria:

* Bipolar disorder
* Schizophrenia or other psychosis
* Major Depression

Primary outcomes:
measure: CGI Improvement
timeFrame: Post Treatment
Secondary outcomes:
measure: Hamilton Depression
timeFrame: Post Treatment
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Javier I Escobar, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers, The State University of New Jersey
name: Michael A Gara, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Escobar JI, Gara MA, Diaz-Martinez AM, Interian A, Warman M, Allen LA, Woolfolk RL, Jahn E, Rodgers D. Effectiveness of a time-limited cognitive behavior therapy type intervention among primary care patients with medically unexplained symptoms. Ann Fam Med. 2007 Jul-Aug;5(4):328-35. doi: 10.1370/afm.702.
Clinical trial NCT01917383: A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Official title: A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open-Angle Glaucoma (POAG)
Ocular Hypertension (OHT)
Keywords: glaucoma
primary open angle glaucoma
ocular hypertension
adenosine agonist
eye drop
trabodenoson
trabecular meshwork
Lead sponsor: Inotek Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

Detailed description: Criteria

Inclusion Criteria:

1. Subject has signed and dated the current informed consent form (ICF).
2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
3. Aged 18 or older.
4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Eligibility criteria: Inclusion Criteria:

1. Subject has signed and dated the current informed consent form (ICF).
2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
3. Aged 18 or older.
4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Chiltern
state: Tennessee
Study officials:
References: