louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04273321: Efficacy and Safety of Corticosteroids in COVID-19
Official title: Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Novel Coronavirus Pneumonia
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.


Eligibility criteria: Inclusion Criteria:

* age more than 18 years old
* accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
* admitted in the general wards
* be able to sign informed consent

Exclusion Criteria:

* severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
* pregnant or lactation period women
* glucocorticoids are needed for other diseases
* unwilling or unable to participate or complete the study
* participate in other study

Primary outcomes:
measure: the incidence of treatment failure in 14 days
timeFrame: 14 days
Secondary outcomes:
measure: clinical cure incidence in 14 days
timeFrame: 14 days
measure: the duration of virus change to negative
timeFrame: 30 days
measure: mortality at day 30
timeFrame: 30 days
measure: ICU admission rate in 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei province hospital of integrated Chinese & Western Medicine
state: Hubei
city: Yichang
country: China
facility: Yichang first people's Hospital
state: Hubei
city: Beijing
country: China
facility: Beijing YouAn Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Tianyou Hospital Affiliated to Wuhan University of science and technology
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
city: Xiangyang
country: China
facility: the first peopel hospital of Xiangyang
Study officials:
References:
citation: Tang X, Feng YM, Ni JX, Zhang JY, Liu LM, Hu K, Wu XZ, Zhang JX, Chen JW, Zhang JC, Su J, Li YL, Zhao Y, Xie J, Ding Z, He XL, Wang W, Jin RH, Shi HZ, Sun B. Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial. Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.
Clinical trial NCT05751421: Pain Relief After PrimaryTKA
Official title: Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Patients undergoing primary unilateral TKA
* Patients receiving spinal anesthesia during primary TKA
* Patients with adequate cognitive function to participate and complete questionnaires for the study

Exclusion Criteria:

* Patients undergoing bilateral simultaneous TKA
* Patients undergoing conversion TKA
* Patients undergoing unicompartmental knee arthroplasty
* Patients undergoing patellofemoral arthroplasty
* Patients with an allergy to NSAIDs or bupivacaine
* Patients who have a contraindication to the use of NSAIDs
* Patients who are using chronic anticoagulation, precluding them from using NSAIDs
* Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome
* Patients who are determined to be in severe pain from other concomitant conditions
* Patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.

Primary outcomes:
measure: Postoperative pain
timeFrame: 14 days
measure: Opioid consumption
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04677621: TEND Study:Telemedicine Nurse DBS for Parkinson's Disease
Official title: Telemedicine Nurse DBS for Parkinson's Disease: The TEND Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Home Health
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The central hypothesis is that home health nurses can improve access and provide high quality care when guided by a sophisticated platform that integrates bioinformatics, patient-specific computational modeling, and continuous symptom measurement.


Eligibility criteria: Inclusion Criteria:

* Pre-operative Inclusion Criteria: A good response to levodopa is required in order to exclude patients with Parkinson's plus syndromes, and will be defined as a 30% improvement in parkinsonian motor signs based upon the Unified PD Rating Scale (UPDRS) motor examination subscore, following the administration of 1.5 times the typical dopaminergic dose during the screening neurological examination. Patients must also have PD for a minimum of 5 years duration.
* Additional inclusion criteria consist of: 1) Hoehn \& Yahr stage II or worse when off; 2) Intractable, disabling motor fluctuations and/or tremor; 3) Age between 30-75 years; 4) Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of antiparkinsonian drugs). 5) A stable/optimal medical regimen of antiparkinsonian drug therapy for at least one month prior to surgery; 6) access to high-speed internet in the home.

Exclusion Criteria:

* Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
* Evidence of secondary or atypical parkinsonism.
* MRI scan with significant evidence of brain atrophy or other abnormalities.
* Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
* A major untreated psychiatric disorder.

Primary outcomes:
measure: The number of participant clinic visits
timeFrame: 6 MONTHS from date of enrollment
Secondary outcomes:
measure: PDQ-39 Scores
timeFrame: 6-months
Other outcomes:
measure: UPDRS scores
timeFrame: 6-months
Locations:
Study officials:
affiliation: University of Florida
name: Michael Okun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06101121: Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
Official title: Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urethral Catheter; Complications
Lead sponsor: B. Braun Medical SA
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: See eligibility criteria

Brief summary: The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.

Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.

Detailed description: The study is designed as a prospective, multicenter, single-group, observational study to evaluate Lubri-cream for urethral catheterization and cystoscopies lubrication. At least 2 different centers located in Spain will participate.

It is primarily aimed to collect data on the performance of the product under investigation in a large patient population when used in routine clinical practice. Safety and performance of Lubri-cream will be assessed to study the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
* Signed informed consent

Exclusion Criteria:

* Contraindications as stated in the Instructions for Use
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
* Inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the Investigational Product.

Primary outcomes:
measure: Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
timeFrame: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)
Secondary outcomes:
measure: Safety of Lubri-cream based on routinely measured clinical parameters
timeFrame: During catheter insertion and catheter removal
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitari Mútua Terrassa
name: Anna Maria Martínez, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205021: Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome
Official title: Compartmental Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective search of whole-body PET/CT examinations and consecutively selected imaging studies.

Brief summary: Accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* no history of malignancy at the time of image acquisition
* fasting glucose measured immediately prior to PET/CT

Exclusion Criteria:

* history of neck cancer, radiation therapy, and/or surgery

Primary outcomes:
measure: Relationship of specific neck compartments to cardiovascular risk
timeFrame: 1 year between PET/CT and cardiometabolic marker measures
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Martin Torriani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torriani M, Gill CM, Daley S, Oliveira AL, Azevedo DC, Bredella MA. Compartmental neck fat accumulation and its relation to cardiovascular risk and metabolic syndrome. Am J Clin Nutr. 2014 Nov;100(5):1244-51. doi: 10.3945/ajcn.114.088450. Epub 2014 Sep 3.
Clinical trial NCT00214721: A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
Official title: A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2005-09-22
Enrollment: 120
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: Objective: The purpose of this study is to demonstrate:

-the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have given written informed consent after the nature of the study has been explained.
* Patients who are at least 18 years of age.
* Patients who have been treated with CAPD using specific solutions for at least 60 days before the baseline visit.

Exclusion Criteria:

* Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit. - Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
* Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection.
* Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit.
* Patients who have severe malnutrition (serum albumin \< 25 g/l by bromocresol green method).
* Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
* Patients who have received an investigational product within 30 days preceding the screening visit.
* Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
* Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
References:
Clinical trial NCT03339921: Botulinum for Chronic Exertional Compartment Syndrome
Official title: Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Chronic Exertional Compartment Syndrome
Lead sponsor: 375th Medical Group, Scott Air Force Base
Sponsor class: FED
First posted: 2017-11-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.

Detailed description: The study will be a prospective cohort pilot study designed to compare Active Duty patients, 18 years of age or older, with Chronic Exertional Compartment Syndrome (CECS) undergoing two different treatment interventions. The first arm will be patients receiving investigational botulinum toxin injections. The second arm will be patients who undergo the standard of care surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one, three, and six months post-treatment. Clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, LEFI and pain on the Universal Pain Assessment Tool.

Eligibility criteria: Inclusion Criteria:

* Adult ages 18-65
* Active duty military
* Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb
* Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine
* Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria.

Exclusion Criteria:

* Prior Botulinum toxin injections into the affected limb
* Prior compartment release of the affected limb
* Pregnant or becomes pregnant during the study
* Standard of care clinical exams indicating other more likely causes of leg pain

Primary outcomes:
measure: Lower Extremity Functional Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scott Air Force Base
country: United States
facility: 375th Medical Group
state: Illinois
Study officials:
affiliation: Principal Investigator
name: Brett Boyce, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06248021: Ecological Footprint Awareness Program in 60-72 Months Children
Official title: Effectiveness of Ecological Footprint Awareness Program in 60-72 Months Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Program, Communication
Keywords: environment
ecology
awareness
child
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted using a cluster randomized controlled pretest-posttest experimental design. It was carried out in four kindergartens located in a city center between April and June 2023. Two of the kindergartens were assigned to the intervention group while the other two were assigned to the control group. Data was collected using the Ecological Footprint Awareness Scale for Children (EFAS-C). The training program was conducted with the children in the intervention group for four weeks, with a 40-minute session each week. The program covered one topic each week, which included waste management, water and energy use, food consumption, and transportation.
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate the effectiveness of an ecological footprint awareness training program for children aged 60-72 months.

Detailed description: This study was conducted using a cluster randomized controlled pretest-posttest experimental design. It was carried out in four kindergartens located in a city center between April and June 2023. Two of the kindergartens were assigned to the intervention group while the other two were assigned to the control group. Data was collected using the Ecological Footprint Awareness Scale for Children (EFAS-C). The training program was conducted with the children in the intervention group for four weeks, with a 40-minute session each week. The program covered one topic each week, which included waste management, water and energy use, food consumption, and transportation. The data was analyzed using descriptive statistics, paired groups t-test, and independent groups t-test, with a 95% confidence interval and p\<.05 significance level.

Eligibility criteria: Inclusion Criteria:

* enrolled in the schools where the study was conducted
* Approved by their family to participate in the study,
* 60-72 months old

Exclusion Criteria:

* participation in less than 2/3 of the intervention protocol

Primary outcomes:
measure: Ecological Footprint Awareness Scale for 60-72 Month-old Children scores
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
References: