louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04503161: The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
Official title: The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: CSF Leak
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18
* Planned for skull base surgery
* Able to understand and willing to sign a written informed consent form

Exclusion Criteria:

* active skull base infection
* no plan for DuraGen repair by operating surgeon

Primary outcomes:
measure: Rate of CSF leak
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Need for reoperation
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Postoperative hematoma
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Postoperative infection
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Need for rehospitalization
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
measure: Death
timeFrame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05530161: Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy
Official title: Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coagulopathy
Trauma
Keywords: trauma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 371
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020

Brief summary: Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis.

Detailed description: This 5-year retrospective, observational, single-center study was conducted at the Second Affiliated Hospital of Zhejiang University Medical School (SAHZU, China). Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020.The purpose of this study is to elucidate the effect of hypocalcemia on TIC in elderly trauma patients through a single-center retrospective study, so as to further optimize the diagnosis and treatment strategies for TIC in elderly trauma patients.

Eligibility criteria: Inclusion Criteria:

* age≥65 years old
* history of trauma

Exclusion Criteria:

* previous anticoagulants or antiplatelet medication;
* Coagulopathy caused by previous underlying diseases;
* Blood products transfused before admission;
* Cardiac arrest on admission;
* Malignant tumor;
* Data incomplete

Primary outcomes:
measure: Internationalized Normalized Ratio (INR)
timeFrame: 24 hour
measure: Activated Partial Thromboplastin Time (APTT)
timeFrame: 24 hour
measure: Prothrombin Time (PT)
timeFrame: 24 hour
Secondary outcomes:
measure: Blood products rate
timeFrame: through study completion, an average of 1 week
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: SAHZU
state: Zhejiang
Study officials:
affiliation: Department of Emergency medicine，Second Affiliated Hospitalof Zhejiang University
name: yongan xu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01628861: Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work
Official title: Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adult Office Workers
Keywords: occupation
work
sitting
sedentary behaviour
office worker
adult
education
point-of-choice prompt
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether an on-screen prompt put on the work computer every 30 minutes is effective in getting office workers to reduce prolonged periods of sitting at work.

Detailed description: Prolonged bouts of uninterrupted time spent sitting is associated with indicators of poor health, independent of how physically active a person is. Many occupations are now sedentary, and are characterised by long periods spent sitting at a desk. Brief education on the benefits of standing regularly and breaking up prolonged sitting will be provided to participants, working at a Scottish University. One intervention group will additionally have software installed on their work computer which placed a prompt window in the centre of their screen for 1 minute every 30 minutes. The prompt will remind participants to stand-up and take a break, and the window cannot be removed or minimised.

Eligibility criteria: Inclusion Criteria:

* Employee of Glasgow Caledonian University
* Aged between 18 and 65 years
* Self-reported desk-based occupation
* Informed written consent provided
* Ability to stand unassisted

Exclusion Criteria:

* Any musculoskeletal condition which limits ability to stand regularly

Primary outcomes:
measure: duration of prolonged sitting
timeFrame: 5 days
Secondary outcomes:
measure: total sitting duration
timeFrame: 5 days
measure: number of sitting events
timeFrame: 5 days
measure: step count
timeFrame: 5 days
measure: break duration
timeFrame: 5 days
measure: walking time
timeFrame: 5 days
measure: standing time
timeFrame: 5 days
measure: number of prolonged sitting events
timeFrame: 5 days
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: School of Health & Life Sceinces, Glasgow Caledonian University
state: Lanarkshire
Study officials:
affiliation: Glasgow Caledonian University
name: Philippa M Dall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans RE, Fawole HO, Sheriff SA, Dall PM, Grant PM, Ryan CG. Point-of-choice prompts to reduce sitting time at work: a randomized trial. Am J Prev Med. 2012 Sep;43(3):293-7. doi: 10.1016/j.amepre.2012.05.010.
Clinical trial NCT04860661: Esketamine on Postpartum Depression in Cesarean Section Women
Official title: Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esketamine
Postpartum Depression
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Maternal and Child Health Hospital of Hubei Province
name: Jingmen No.1 People's Hospital
First posted: 2021-04-27
Enrollment: 336
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.
Primary purpose: PREVENTION

Brief summary: This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug

Detailed description: Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section;
* 18-40 years;
* Primipara;
* Singleton pregnancy;
* Sign informed consent.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) grade III and above;
* Intracranial hypertension;
* Hypertension;
* Severe heart disease;
* Hyperthyroidism patients without treatment or insufficient treatment;
* Liver and kidney dysfunction;
* Preeclampsia or eclampsia;
* Mental disorder, mental retardation;
* Drug abuse and alcoholism;
* Contraindication of intraspinal anesthesia;
* The preoperative EPDS score ≥10;
* Participated in other clinical studies.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale(EPDS） scores
timeFrame: up to 90 days after surgery
Secondary outcomes:
measure: Numeric Rating Scale (NRS) score
timeFrame: 1 Day before operation
measure: total number of patient-controlled analgesia (PCA) compressions
timeFrame: up to 24 hours after operation
measure: total volume of PCA
timeFrame: up to 24 hours after operation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Department of Anesthesiology of Tongji Hospital
name: Ailin luo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206361: Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom
Official title: Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Keywords: Real world
observational
retrospective
database analysis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-21
Enrollment: 2015
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who had received a prescription for either Xalacom, Ganfort and DuoTrav, \> 18 years old, diagnosed with glaucoma or ocular hypertension, registered at the primary care practice for \> 12 months

Brief summary: The hypothesis is that there is no difference in persistency between Xalacom and the alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.


Eligibility criteria: Inclusion Criteria:

* Patients who had received a prescription for either Xalacom, Ganfort and DuoTrav
* Greater than 18 years old
* Diagnosed with glaucoma or ocular hypertension
* Registered at the primary care practice for \> 12 months

Exclusion Criteria:

* None

Primary outcomes:
measure: Frequency distribution of persistent and non-persistent patients across study cohorts
timeFrame: 12 months
measure: Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts
timeFrame: 12 months
measure: Time to discontinuation of each cohort
timeFrame: 12 months
Secondary outcomes:
measure: Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension
timeFrame: 12 months
measure: Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy
timeFrame: 12 months
measure: Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists
timeFrame: 12 months
measure: Prostaglandin mono-therapies
timeFrame: 12 months
measure: The cohort of patients which were evaluated in this study were investigated for the presence of history of disease for asthma, cardiovascular disease, diabetes, renal failure and systemic hypertension. The number of patients in each cohort were
timeFrame: 12 months
measure: presented who had had (i) a 12 month history of any of the diseases or (ii) had had a history of any of the diseases.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03273361: Desk Cycling Work Performance Evaluation
Official title: Desk-Compatible Elliptical Device: Feasibility Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Physical Activity
Overweight
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This lab study is evaluating the feasibility of accomplishing productive office work while simultaneously pedaling a compact desk-based cycling device.


Eligibility criteria: Inclusion Criteria:

* 18-65 years
* Ability to type without looking at the keyboard
* Native English speaker
* Normal hearing
* Spend 6 or more hours per day sitting
* Less than 150 minutes of physical activity per week

Exclusion Criteria:

* Positive response on the Physical Activity Readiness Questionnaire indicating that low intensity pedaling could present safety risks
* Pregnancy
* Body mass index less than 18 or greater than 35

Primary outcomes:
measure: Typing task
timeFrame: 5 minutes
Secondary outcomes:
measure: Reading task
timeFrame: 5 minutes
measure: Logic Reasoning and Phone Task
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Pennsylvania State University College of Medicine
name: Liza Rovniak, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Andris Freivalds, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05612061: Indigenous Recovery Planning for American Indians
Official title: Randomized Controlled Trial of Indigenous Recovery Planning for American Indians
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Use Disorder
Substance Use Disorders
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list control group
Primary purpose: TREATMENT

Brief summary: This research project uses a Community-Based Participatory Research (CBPR) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the Fort Peck Indian Reservation in northeastern Montana and research partners from Montana State University. The Indigenous Recovery Planning intervention employs trained Fort Peck community members to deliver manualized intervention content to American Indian adults with substance use disorder (SUD). By increasing access to culturally responsive evidence-based treatment, this research aims to decrease SUD-related health disparities and improve public health outcomes for underserved Native communities locally and nationally.


Eligibility criteria: Inclusion Criteria:

* American Indian, 18 years of age or older, living on the Fort Peck reservation, meeting diagnostic criteria for Substance Use Disorder, wanting treatment/help with recovery.

Exclusion Criteria:

* Not meeting inclusion criteria.

Primary outcomes:
measure: Percent days absent
timeFrame: At Time 1, we will assess alcohol and drug use in the 90 days prior to assessment, and each subsequent assessment will measure use in the time since the previous one (approximately 6 weeks).
Secondary outcomes:
measure: Number of substance-related consequences experienced within the past 6 weeks
timeFrame: Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)
Other outcomes:
measure: Quality of life score
timeFrame: Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)
Locations:
city: Poplar
country: United States
facility: Fort Peck Community College
state: Montana
Study officials:
affiliation: Montana State University
name: Monica Skewes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04963361: Study on Fear of Movement After Total Knee Arthroplasty
Official title: A Survey of Fear of Exercise and Its Influencing Factors in Patients After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Knee Arthroplasty
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after total knee arthroplasty

Brief summary: Total knee arthroplasty is one of the effective methods for the treatment of end-stage osteoarthritis. Postoperative rehabilitation exercise is an important method for the recovery of knee joint function. Exercise fear refers to an enlarged psychological phenomenon that patients are afraid of sports leading to injury, which is not conducive to the functional exercise of patients and hinders the recovery of knee joint function

Detailed description: Object: the purpose of this study is to investigate the occurrence of fear of movement after total knee arthroplasty and analyze its influencing factors, so as to provide theoretical basis for reducing the occurrence of fear of movement after total knee arthroplasty, promoting the rehabilitation exercise of patients and promoting the recovery of knee joint function.

In this study, 121 patients with total knee arthroplasty were investigated by questionnaire, including general demographic data, sports fear scale, anxiety and depression scale, self-efficacy scale and so on. Multivariate logistic regression was used to analyze the influencing factors of postoperative fear of exercise.

Eligibility criteria: Inclusion Criteria:

（1） meeting the criteria of knee arthritis established by American Society of rheumatology （ 2) Total knee arthroplasty was performed for the first time （ 3) Good Chinese reading and comprehension ability （ 4) The patient's condition was stable, and there were no serious diseases of the heart, lung, brain and other important organs （ 5) Informed of the study and signed informed consent.

Exclusion Criteria:

（1）deep venous thrombosis of lower extremity （ 2) Other diseases affecting walking function （ 3) Suffering from cognitive or mental disorders （ 4) Had a history of knee surgery

Primary outcomes:
measure: The occurrence of fear of movement
timeFrame: 2nd day post-operative
Secondary outcomes:
measure: Hospital Ansiety and Depression Scale(HADS)
timeFrame: 2nd day post-operative
measure: General Self Efficacy Scale(GSES)
timeFrame: 2nd day post-operative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Tao Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05885061: Effects of Spinal Cord Stimulation
Official title: Effects of Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-06-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is:

• What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.


Eligibility criteria: Inclusion Criteria:

* Patients (\>18 years of age) with SCS implanted to treat chronic pain.
* Patients who consent to participation and can cooperate in the study.
* Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.
* Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.
* Patients not receiving other neuromodulation treatment.
* Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).

Primary outcomes:
measure: Pain intensity, Visual Analogue Scale
timeFrame: Every 30 minutes during study session (max 5 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Neurosurgery, Aarhus University Hospital
Study officials:
References: