louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01929252: Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy
Official title: Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: dexmedetomidine
wound infiltration
postoperative analgesia
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.

Detailed description: Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective analgesia after hysterectomy essential and several techniques are used such as administration of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local anaesthetics. Different local anaesthetics can be used for the wound infiltration techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides pain relief in the postoperative period , allows the early discharge from the outpatient surgical units.There has been increased interest in administration of analgesic prior to surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine has been used intravenously before initiation of anaesthesia and it has shown to provide some analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic effects of intravenous administration while still providing the postoperative analgesia.

Eligibility criteria: Inclusion Criteria:

* 18-65 yo female
* scheduled for elective hysterectomy
* no known allergies to drugs
* ASA 1=2 patients

Exclusion Criteria:

* history of diabetes
* history of chronic pain treatment
* pregnancy

Primary outcomes:
measure: Analgesic Consumption
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 1 day after surgery
measure: Haemodynamic Changes
timeFrame: During the surgery
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes university hospital
Study officials:
affiliation: TC Erciyes University
name: Fatih M. Kurt, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: TC Erciyes University
name: Ayse Ulgey, Asst. Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05014152: Prospective Trial for Clinical Validation of "QOCA Disposable BLE Thermometer "
Official title: Prospective Trial for Clinical Validation of "QOCA Disposable BLE Thermometer "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Quanta Computer Inc.
First posted: 2021-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this trial is to evaluate the accuracy and safety of the "QOCA Disposable Body Temperature Patch" (Q-temp-w1).

Detailed description: Q-temp-w1 is a contact type body temperature patch developed by Quanta Computer Co., Ltd. It is mainly used to measure the body temperature of the human body. It can be used for general body temperature measurement, home temperature measurement records and medical tracking. Both the European Union and the US FDA state that the clinical test methods of the temperature patch must comply with ISO 80601-2-56. Therefore, this test plan will follow the ISO 80601-2-56 criteria to evaluate the accuracy of the temperature patch and follow it. The sampling age range and the fever/non-fever ratio are stratified, and clinical efficacy analysis is performed based on the measurement results. The main evaluation indicators include clinical bias, limits of agreement, and clinical repeatability.

Eligibility criteria: Inclusion Criteria:

* 1. Male or female aged between 0-100 years.
* 2. Patient agrees to participate in the trial and sign informed consent.

Exclusion Criteria:

* 1. Those who have any broken skin or skin diseases on the part of the body which is the test site of the BLE thermometer, Including the underarms and the back of the body.
* 2. Those whose test site of the BLE thermometer are known to be contaminated by uncle arable body fluids, or lead to the inaccurate of the BLE thermometer.
* 3. Those who have restlessness or other conditions that make them unable to tolerate the temperature measurement procedure.

Primary outcomes:
measure: Clinical bias
timeFrame: 10 min
Secondary outcomes:
measure: Safety /Adverse Event Outcome Measure
timeFrame: 20 min / 24 hour (until recovered if it's SAE)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGungMH
Study officials:
affiliation: Chang Gung Medical Fundation
name: Chin-Jung Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06878352: Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma
Official title: Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Asthma
Heath Education
Spirometry
Respiratory Tract Disease
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 28
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma.

Participants allocated to the control group will receive standard follow-up according to the clinic routine. Participants allocated to the experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024).

Detailed description: People with asthma will participate in the study, from the Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraíba - UFPB. Spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the Asthma Control Test (ACT) and C-ACT questionnaire, number of asthma attacks, amount of medication used, hospitalizations and visit to the emergency room in the last 4 weeks will be assessed. Assessments will be carried out at the first contact (baseline) and twelve weeks after the first contact.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of asthma
* Assisted by the Pulmonary Function Clinic
* Ventilatory dysfunction assessed by spirometry

Exclusion Criteria:

* Obesity
* Treatment with systemic corticosteroids
* Previous chest surgery
* Unable to perform any of the proposed assessment steps

Primary outcomes:
measure: clinical asthma control
timeFrame: Baseline and 4 weeks
measure: Retention of information about asthma knowledge and inhalation therapy
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: hospitalizations and emergency room visits
timeFrame: Baseline and 4 weeks
measure: Pulmonary function - Spirometry
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraiba
state: Paraíba
Study officials:
References:
Clinical trial NCT01872052: Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Official title: Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 9
Sex: ALL
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: Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* One documented occurrence of typical AFL within the past 6 months
* Be able and willing to sign informed consent

Exclusion Criteria:

* Contraindication to a non-emergent interventional EP procedure
* Require treatment in or access to left atrium
* Had a myocardial infarction within the prior two months
* Had cardiac surgery within the prior three months
* Intracardiac thrombus
* Permanent pacemaker/ICD leads in/through right atrium
* Clinically significant tricuspid valve regurgitation or stenosis
* Cerebral ischemic event (including TIA) in the prior six months
* Pregnant
* Currently enrolled in any other clinical investigation
* Any other significant uncontrolled or unstable medical condition

Primary outcomes:
measure: The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
timeFrame: 3 months post-procedure
measure: The number of patients that experience a device-related adverse events as a measure of safety and tolerability
timeFrame: 7 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Stephan Willems, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550752: Erectile Dysfunction Treatment Using Stem Cells
Official title: Intracavernous Injection of Umbilical Cord Stem Cells and Platelet-Rich Plasma for the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: COR clinic of Regenerative Medicine
Sponsor class: NETWORK
First posted: 2024-08-13
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective clinical study to investigate the safety and efficacy of intracavernosal injections of umbilical cord stem cells (UCSCs) combined with platelet-rich plasma (PRP) for erectile dysfunction

Detailed description: Umbilical cord mesenchymal stem cells (UC-MSCs) combined with platelet-rich plasma (PRP) will be injected into the corpora cavernosa of the penis of male patients with erectile dysfunction. The injection will be done at four points along the shaft on both sides of the penis. Penile Doppler ultrasonography will be performed on all patients before the initiation of the treatment. This assessment will be conducted to establish a baseline measurement of penile blood flow in both left and right sides of the penis. Subsequently, after four months of treatment, penile duplex Doppler ultrasonography will be repeated to compare the penile doppler before and after treatment. Statistical analyses will be performed using IBM SPSS Statistics for Windows, version 26.

Eligibility criteria: Inclusion Criteria:

* male patient with erectile dysfunction

Exclusion Criteria:

* undergo other treatments for erectile dysfunction

Primary outcomes:
measure: Penile Doppler ultrasonography for assessment of erectile function
timeFrame: before treatment and after 4 months
Secondary outcomes:
measure: Adverse effects
timeFrame: Directly after the injection and after two weeks
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: COR clinic for Regenerative Medicine
Study officials:
affiliation: COR clinic for Regenerative Medicine
name: Nada Alaaeddine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06788652: A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
Official title: Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mantle Cell Lymphoma (MCL)
Keywords: Mantle Cell Lymphoma (MCL)
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults diagnosed with Relapsed/Refractory Mantle Cell Lymphoma (MCL) who are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry and have been treated with lisocabtagene maraleucel.

Brief summary: The purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of Mantle Cell Lymphoma (MCL).


Eligibility criteria: Inclusion Criteria:

• Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA

Exclusion Criteria:

* Participants known to be participating in investigational studies at the time of liso-cel infusion.
* Participants treated with non-conforming CAR T-cell product.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 15 years
Secondary outcomes:
measure: Complete remission rate (CRR)
timeFrame: Up to 15 years
measure: Overall response rate (ORR)
timeFrame: Up to 15 years
measure: Progression-free survival (PFS)
timeFrame: Up to 15 years
measure: Overall survival (OS)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Center for International Blood and Marrow Transplant Research (CIBMTR)
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04811352: Drug Abuse During the COVID-19 Pandemic.
Official title: Readiness for a Pandemic, and Factors Associated With Substance Abuse During the COVID-19 Pandemic - A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Abuse
Stress, Psychological
Keywords: substance abuse
COVID-19
stress
economical impact
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Mexican general population during the COVID-19 pandemic.

Brief summary: The pandemic we live through has put various sectors of the medical system and its tributaries to the test. The accumulation of external and internal stress has been completely correlated with the predisposition to psycho-emotional problems and, in turn, to drug use as an immature response for ego protection. That is why the economic, social, and psychological evaluation can help understand the current situation about drug abuse and how to help patients afflicted by it. The added stress of personal problems, work alterations, daily life in a pandemic, economic and varied responsibilities, and the understanding of the pandemic have predisposed and amplified the use of drugs to reduce emotional distress perceived by individuals. The hypothesis of this study is that the increment of stress and a lack of preparation for the pandemic are associated with increased drug abuse.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Willing to participate in the study
* Patient currently with a paying job

Exclusion Criteria:

* Patients without a paying job

Primary outcomes:
measure: Behaviour on drug and substance abuse
timeFrame: Baseline
measure: PHQ-9 Score
timeFrame: Baseline
measure: GAD-7 Score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Médico Nacional de Occidente
state: Jalisco
Study officials:
References:
Clinical trial NCT03179852: Effects of Nutrition Education on 3rd and 5th Grade Student's Fruit and Vegetable Consumption and Knowledge
Official title: Effects of Nutrition Education on 3rd and 5th Grade Student's Fruit and Vegetable Consumption and Knowledge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Central Washington University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess pre- and post-intervention nutrition education knowledge and preference. The secondary objective is to assess pre- and post-intervention fruit and vegetable consumption via a plate waste study.

Detailed description: Background: The prevalence of overweight and obese children in the United States is at epidemic proportions, making it a recognized public health priority. Overweight and obese children are more likely to remain overweight and obese as adults, which increases their risk for developing obesity-related diseases and psychological disorders. Research shows that regular consumption of fruit and vegetables (F/V) may reduce the risk of obesity and obesity-related diseases yet most American school children fail to meet recommended intakes .

Objective: The purpose of this study was to determine if a F/V-targeted nutrition education intervention would increase F/V preference, knowledge, and consumption among elementary-school students.

Methods: Eight 20-minute nutrition lessons, focusing on F/V consumption, were administered over an eight-week period to 3rd and 5th grade students (N=150) at a local Ellensburg School District elementary school . Pre/post surveys were used to examine F/V knowledge and preference. Researchers observed and photographed students' lunches for 5-consecutive days pre- and post- intervention to assess possible change in consumption patterns.

Results: Data is currently under analysis. Conclusions: To be determined June 2017.

Eligibility criteria: Inclusion Criteria:

* Participated in the National School Lunch Program

Exclusion Criteria:

* Did not participate in the National School Lunch Program

Primary outcomes:
measure: Change in nutrition knowledge
timeFrame: Nutrition knowledge surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention
measure: Change in fruit and vegetable preferences
timeFrame: Fruit and vegetable preference surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention
Secondary outcomes:
measure: Change in fruit and vegetable intake
timeFrame: Plate waste will be measured via the quarter waste method during week 1 and again at week 10 after the 8 week nutrition education intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00473252: Surveillance of Fungal Infections During Construction Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspergillosis
Keywords: aspergillus infections
immunosuppression
kidney transplantation
hemodialysis
galactomannan test
fine dust
construction activity
airborne aspergillus spores
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 340
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prevalent hemodialysis patients and incident renal transplant recipients in the Department of Nephrology and Hypertension, University Hospital Bern, Switzerland

Brief summary: Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported.

However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively.

To answer this question, we will monitor our immunosuppressed patients' health status, as well as fine dust and aspergillus spore contents in the air during a three year construction activity period in our hospital.


Eligibility criteria: Inclusion Criteria:

* Kidney transplantation
* Chronic hemodialysis treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dept. Nephrology & Hypertension, Univ. Hospital Bern
Study officials:
affiliation: University of Bern
name: Andreas Pasch, MD
role: STUDY_DIRECTOR
References: