louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05773482: Effects of Breathing and Attention Training (BAT) on Pain Modulation
Official title: Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This parallel study will be age \& sex matched, and randomized.
Primary purpose: BASIC_SCIENCE

Brief summary: The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.


Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with fibromyalgia will have pain of duration \> 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)
* Healthy, pain-free age matched controls without chronic pain

Exclusion Criteria:

* Personal or family history of photosensitive epilepsy
* Prior history of cancer or diabetes
* Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.

Primary outcomes:
measure: Ratings of Painful and Painless Sensory Stimuli
timeFrame: 2 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Roland Staud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00293982: The Influence of Expectations on Patient Satisfaction in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: Patient satisfaction
Patient expectations
Pediatric emergency department
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 948
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine whether physician knowledge of parental pre-visit expectations improves patient satisfaction in the pediatric emergency department.


Eligibility criteria: Inclusion Criteria:

* Parent of child less than or equal to 18 years of age

Exclusion Criteria:

* Inability to understand the English language surveys

Primary outcomes:
measure: Patient satisfaction as measured by:
measure: 1. ratings of overall care
measure: 2. willingness to recommend the ED
Secondary outcomes:
measure: Ratings of degree to which expectations were met
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Christopher D Spahr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: David C Brousseau, MD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04621682: Non-technical Skills Training and Checklists Versus Standard Training With Checklists for Prevention of Medical Error
Official title: Non-technical Skills Training and Checklists Versus Standard Training With Checklists in Boarding School Students to Reduce Simulation Crisis Medical Error, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Emergencies
Keywords: medical error
high fidelity simulation
non technical skills
checklist
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TECRISIS is a study designed as a controlled clinical trial of superiority with parallel groups, random allocation and blinding of investigators who measure outcome.
Primary purpose: OTHER

Brief summary: The purpose of this study is to reduce medical error by omitting management steps in medical crises. The Interventions will be: training in non-technical skills and checklists versus Control: standard training with checklists

Detailed description: 56 participants will be searched for simulation training, randomly assigned in assignment 1 to 1, the follow-up will be 10 days, the primary outcome will be Proportion of omissions of treatment steps per group, and secondary outcomes will be sought. Crisis resolution time, detection time. and discrimination from the crisis Global score of non-technical skills, Discriminated score between dimensions of non-technical skills, Student satisfaction and Incidence of inadequate crisis management.

Eligibility criteria: Inclusion Criteria:

* over 18 years old.
* Final semester student of medicine at the University of Antioquia.
* Have passed the theoretical knowledge exam for handling crisis events with a score of 100%.
* On-site availability on training days

Exclusion Criteria:

* Having received training in a specific crisis resource management course.
* Refusing to participate

Primary outcomes:
measure: Medical error
timeFrame: 3 days after finishing the training
Secondary outcomes:
measure: Overall score on non-technical skills scale Ottawa
timeFrame: 3 days after finishing the training
measure: score for each non-technical skill category on the ottawa scale
timeFrame: 3 days after finishing the training
measure: Crisis resolution time
timeFrame: 3 days after finishing the training
measure: Time in detection and discrimination of the crisis
timeFrame: 3 days after finishing the training
measure: Incidence of improper handling
timeFrame: 3 days after finishing the training
measure: Student understanding of strategies
timeFrame: 10 days after finishig the primary outcome
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Mario Andres Zamudio
state: Antioquia
Study officials:
References:
Clinical trial NCT04854382: Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
Official title: Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Keywords: Digital health literacy
Health literacy
Fear of coronavirus
Self-perceived health
Teach-back
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized clinical trial focusing on the effect of tailored information on Covid-19 for patients with chronic kidney disease stage 5 on health literacy, anxiety and self-perceived health.

Detailed description: This single-center randomized open clinical trial in persons with chronic kidney disease stage 5 investigates the effect of information about coronavirus targeted at the study population, using study specific information videos followed by a teach-back method. We measure digital, functional, interactive and critical health literacy, fear of coronavirus and self-perceived health at baseline and end-of-study. Patients are followed from May-July 2021 through February 2022 (study period 7-9 months).

Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease stage 5

Exclusion Criteria:

* Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.

Primary outcomes:
measure: Digital health literacy
timeFrame: 9 months
Secondary outcomes:
measure: Health literacy
timeFrame: 9 months
measure: Self-perceived Health
timeFrame: 9 months
measure: Anxiety / concern
timeFrame: 9 months
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Ivar A Eide, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01983982: Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms
Official title: Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms in Early Stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Chronic Pain
Keywords: Breast Cancer
Chemotherapy
Chronic Pain
Survivorship
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Damon Runyon Cancer Research Foundation
First posted: 2013-11-14
Enrollment: 30
Sex: FEMALE
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: Women initiating adjuvant chemotherapy to treat stage I-III breast cancer.

Brief summary: Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy.
* Surgical resection should be complete at the time of study enrollment.
* Eastern Cooperative Oncology Group performance status 0-2.

Exclusion Criteria:

* Average pain over the past 24 hours of 4 or greater on a 0-10 scale.
* Peripheral sensory neuropathy grade 2 or higher.
* Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years.
* Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing.
* Pregnant or nursing.
* No prior chemotherapy for any reason

Primary outcomes:
measure: Feasibility of recruiting patients at chemotherapy initiation
timeFrame: 15 weeks
Secondary outcomes:
measure: Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy
timeFrame: 15 weeks
measure: Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05698082: FOS Immunohistochemical Staining of Colorectal Cancer and Its Adjacent Tissues
Official title: Monkeypox and Cancer: a Pan-cancer Based Multi-omics Analysis and Single Cell Sequencing Analysis-Experimental Studies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Monkey Pox
Keywords: Differential expression of gene
Immunohistochemical staining
Tumor microenvironment
Lead sponsor: Cancer Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Colorectal cancer tissue sections were obtained according to the inclusion criteria. The formalin was used to immersed all cancer specimens. And tissues were cut to 5 μm thickness and placed on glass slides before staining. Endogenous peroxidase activity was inhibited and blocked by de-paraffinizing, rehydrating, and using 5% bovine serum albumin at 37ºC for 30 min. The treated sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy.


Eligibility criteria: Inclusion Criteria:

* (a) patients with histologically confirmed CRC (b) patients who underwent resection of the primary tumor (c) patients at first visit who had not received treatment before blood testing.

Exclusion Criteria:

* (a) familial adenomatous polyposis or hereditary colon cancer (b) no signs of clinical infection, such as fever, on the day of blood collection; And (c) patients with multiple primary tumors during hospitalization.

Primary outcomes:
measure: Original survival
timeFrame: Participants were followed up for 3 years, including outpatient follow-up and telephone follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
Study officials:
References:
Clinical trial NCT06150482: Healthcare Utilization in Liver Cirrhosis Patients, a Multicenter Retrospective Cohort Study
Official title: Healthcare Utilization in Liver Cirrhosis Patients, a Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Gelre Hospitals
First posted: 2023-11-29
Enrollment: 600
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: Patients with liver cirrhosis

Brief summary: Multicenter, retrospective cohort study investigating healthcare utilization in compensated and decompensated liver cirrhosis patients, including disease course and characteristics associated with healthcare utilization and, for example psychosocial factors.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age
* Liver cirrhosis, based on biopsy, fibroscan or diagnostic imaging data

Exclusion Criteria:

* Known malignancy with hepatic metastasis at baseline
* Liver transplantation at baseline

Primary outcomes:
measure: Number of liver cirrhosis related outpatient contacts before liver cirrhosis complications
timeFrame: 2 years before complication, death or loss to follow-up
measure: Number of liver cirrhosis related radiographic imaging before liver cirrhosis complications
timeFrame: 2 years before complication, death or loss to follow-up
measure: Number of liver cirrhosis related esophagogastroscopies before liver cirrhosis complications
timeFrame: 2 years before complication, death or loss to follow-up
measure: Number of liver cirrhosis related elastographies before liver cirrhosis complications
timeFrame: 2 years before complication, death or loss to follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
Clinical trial NCT01852682: A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peritoneal Dialysis
Hyperphosphatemia
Keywords: Peritoneal Dialysis
Hyperphosphatemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.


Eligibility criteria: Inclusion Criteria:

* Receiving stable maintenance peritoneal dialysis
* Peritoneal dialysis patients with hyperphosphatemia

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder
* Patients having severe gastrointestinal disorders
* Patients having severe hepatic disorders

Primary outcomes:
measure: Serum phosphate concentrations
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidences of Adverse Events
timeFrame: 12 weeks
measure: Incidences of Adverse Events
timeFrame: 28 weeks
measure: Serum phosphate concentrations
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
Study officials:
References:
Clinical trial NCT05490082: Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
Official title: Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Voiding Disorders
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 100
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: A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation


Eligibility criteria: Inclusion Criteria:

* Patients older than age 18 years.
* Able to provide an informed consent.
* Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
* Persistent LUTS after intravesical BCG induction.

Exclusion Criteria:

* International Prostate symptom score (IPSS) greater than 20.
* Post-void residual (PVR) volume greater than 50 ml.
* Use of medications for overactive bladder.
* Pelvic surgery within the previous 6 months.
* Hypersensitivity for BCG or any of the above mentioned drugs.
* Tumor recurrence during follow up period.
* Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma.

Primary outcomes:
measure: Dysuria
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center, Mansoura University
Study officials:
affiliation: Urology and Nephrology Center Mansoura University
name: Ahmed Elhefnawy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04299282: CIED Implantation in Low BMI Patients
Official title: A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Diseases
Cardiac Disease
Keywords: CIED, Pacemaker, ICD, S-ICD
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
Primary purpose: PREVENTION

Brief summary: The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).

Detailed description: A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.

Eligibility criteria: Inclusion Criteria:

* BMI of less than 23.
* Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA:

  * De novo pacemaker, ICD, or S-ICD;
  * Upgrade or change out of existing CIED to a pacemaker, ICD, or S-ICD
* Clinically stable and able to tolerate procedure.
* Be able and willing to return for follow-up care through the 3-month visit.
* Must possess the ability to provide informed consent.

Exclusion Criteria:

* Patients with a known sensitivity to porcine material.
* Participation in another clinical study.
* Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection).
* Female patient who is pregnant, or planning to become pregnant during the length of the study.
* Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months.
* Life expectancy of less than 3 months.

Primary outcomes:
measure: Healing at incision site
timeFrame: 3 months post CIED implantation
Secondary outcomes:
measure: QOL Survey
timeFrame: 3 months post CIED implantation
measure: Vascular Tissue Layer
timeFrame: 3 months post CIED implantation
measure: Skin Fold Test
timeFrame: 3 months post CIED implantation
Other outcomes:
Locations:
Study officials:
affiliation: Elutia Inc.
name: Jerry Riebman, MD, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00630682: A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
Official title: A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Addiction
Keywords: Methamphetamine
Drug Abuse
Drug Treatment
Addiction
Meth
Treatment for Methamphetamine Dependence
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.


Eligibility criteria: Inclusion Criteria:

* 18-50 yrs. old

Exclusion Criteria:

* pregnant or lactating females

  * Contact site for additional information

Primary outcomes:
measure: Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
timeFrame: Twice per week for 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory
state: California
Study officials:
affiliation: Addiction Pharmacology Research Laboratory
name: Gantt Galloway, PharmD
role: PRINCIPAL_INVESTIGATOR
References: