louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04942678: The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
Official title: The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Emotional Regulation
Keywords: Pediatric Emergency Medicine
Therapy Animals
Animal Assisted Therapy
Anxiety
Emotional Regulation
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited at both Norton Children's Hospital Emergency Department and Norton Children's Medical Center Emergency department.

Brief summary: The purpose of this study is to assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department.


Eligibility criteria: Inclusion Criteria:

* Children with a SUD score of 30 or higher indicated by the caregiver

Exclusion Criteria:

* Active infection: abscesses, fever, respiratory issues, vomiting
* Patients presenting for burn care, dog bite, ESI triage category 1 or 2, or transferred from outside facilities
* Sterile procedures
* Oncology patients / patients with known neutropenia in past medical history
* Parent/caregiver or patient fear of dogs
* Parent/caregiver or patient allergy to dogs
* Dog bite injury
* Already underwent procedure during their visit

Primary outcomes:
measure: Change in observed anxiety score as measured by Child Emotional Manifestation Scale (CEMS) before and after therapy dog visit
timeFrame: change from baseline at 20 minutes after intervention
Secondary outcomes:
measure: Change in perceived anxiety level of patient by parent as measured by Subjective Units of Distress Scale (SUDs) before and after therapy Dog Visit
timeFrame: change from baseline at 20 minutes after intervention
measure: Overall Parent Satisfaction
timeFrame: Immediately after completion of intervention
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Michelle D Stevenson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00678678: Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)
Official title: Chest Physiotherapy After Bariatric Surgery - a Comparison Between Incentive Spirometry and Epap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Physiotherapy
Breathing exercises
Bariatric Surgery
Laparoscopy
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2008-05-15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in the pulmonary function after bariatric surgery.

Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2, undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion, on the preoperative and on the second postoperative day. Physiotherapy started on the day of surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The deambulation and active exercises of upper and lower limbs were standardized for groups.


Eligibility criteria: Inclusion Criteria:

* Obese with body mass index between: 35 e 50 kg/m2
* Non-smokers
* No lung disease

Exclusion Criteria:

* Unable to perform the evaluation tests
* Not signed the consentment term

Primary outcomes:
measure: spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion
timeFrame: preoperative and second postoperative day
Secondary outcomes:
measure: Hospital stay and postoperative pulmonary complications
Other outcomes:
Locations:
city: Cariacica
country: Brazil
facility: Meridional Hospital
state: Espirito Santo
Study officials:
References:
Clinical trial NCT06763978: Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA)
Official title: Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamically Significant PDA
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2025-01-08
Enrollment: 357
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: We enrolled all patients with a hemodynamically significant PDA demonstrated by patient clinical condition, and by PDA size \& left chamber dilatation on echocardiography attending at Cardiology Department to we compare the use of a single venous access and a single arterial access with the standard approach requiring both venous and arterial access for transcatheter PDA closure regarding the outcome \& complications.


Eligibility criteria: Inclusion Criteria:

* any patient with hemodynamically significant PDA

Exclusion Criteria:

* patient with pulmonary hypertension and Eisenmenger syndrome

Primary outcomes:
measure: procedural and fluoroscopy time
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT02141178: Comparison of Bupivacaine and Exparel for Carpal Tunnel Release
Official title: Does Long-Acting Liposomal Bupivacaine Provide Improved Pain Relief Over Bupivicaine Alone in Carpal Tunnel Release?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain After Carpal Tunnel Release
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain through the use of a long-acting local anesthetic, the use of narcotic pain medications may be decreased and patient satisfaction scores may increase.

The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine with respect to post-operative pain control, narcotic usage, and patient satisfaction after carpal tunnel release.


Eligibility criteria: Inclusion Criteria:

* Patients with carpal tunnel syndrome undergoing surgery

Exclusion Criteria:

* Non english speaking
* Allergy to bupivacaine or exparel

Primary outcomes:
measure: Pain
timeFrame: Starting immediately after surgery and then every 8 hours for 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01775878: Diabetes Care Management Trial of Telemetric Monitoring
Official title: A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
HbA1c
Fructosamine
Blood Pressure
Telemonitoring
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2013-01-25
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group).

This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors


Eligibility criteria: Inclusion Criteria:

* 18 - 75 years old,
* diagnosis of type 2 diabetes mellitus for at least 1 month,
* eligible for and referred to the diabetes care management program,
* HbA1c values in the range: 7.5% to 10.5%.

Exclusion Criteria:

* Weight \> 330 lbs,
* estimated glomerular filtration rate (GFR) \< 45,
* unstable coronary artery disease,
* severe peripheral vascular disease which restricted exercise,
* end-stage liver disease,
* undergoing treatment for cancer,
* pregnant or not using appropriate birth control,
* no broadband internet access in their homes.

Primary outcomes:
measure: Fructosamine
timeFrame: 6 weeks
measure: glycosylated hemoglobin
timeFrame: 6 months
Secondary outcomes:
measure: blood pressure
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Jerry Minkoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409678: Physical Activity and Preterm Birth With Cervical Dynamics
Official title: Influence of Physical Activity on Preterm Birth for Women With Cervical Dynamics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.


Eligibility criteria: Inclusion Criteria:

pregnant women between 24-34 weeks of gestation singleton cervical length\<25 mm willing to download an application which traces physical activity on medical indication for reducing activity

Exclusion Criteria:

refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy

-

Primary outcomes:
measure: preterm birth
timeFrame: assessed from recruitment to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: edith wolfsom MC
Study officials:
References:
Clinical trial NCT05206578: Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Official title: To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 264
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.

Detailed description: A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Eligibility criteria: Inclusion Criteria:

* Patients with primary hypercholesterolemia

Exclusion Criteria:

* The subject not meet the specified LDL-C level

Primary outcomes:
measure: % change in LDL-C level from baseline at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Change in LDL-C level from baseline at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei severance Hospital
Study officials:
References:
Clinical trial NCT00159978: Validation of 18F-MISO-PET and 18F-FLT-PET
Official title: Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Neoplasms
Keywords: head and neck cancer
hypoxia
tumor cell proliferation
PET
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 21
Sex: ALL
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: Squamous cell carcinoma of the head and neck

Brief summary: Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.

Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.

One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.

The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.


Eligibility criteria: Inclusion Criteria:

* Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.
* Age \>18 years.
* Written informed consent.

Exclusion Criteria:

* Pregnancy.
* Prior treatment for this tumor
* Women breast feeding

Primary outcomes:
measure: To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.
timeFrame: 1 month
Secondary outcomes:
measure: To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning.
timeFrame: 1 month
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC St Radboud, Department of Radiotherapy
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Johannes HA Kaanders, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04517578: European Neuromuscular Monitoring Survey
Official title: European Neuromuscular Monitoring Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Availability of the Different Types of Anesthesia Neuromuscular Monitoring Devices Throughout European Hospitals
Health Care Utilization
Medical Device Availability
Medical Staff Availability
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 692
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anaesthesia departments within the European health system.

Brief summary: This survey aims to better define the availability of the different types of anesthesia neuromuscular monitoring devices throughout European hospitals.


Eligibility criteria: Inclusion Criteria:

* Active Anesthesiology department heads of European Anesthesiology departments.

Primary outcomes:
measure: Questionnaire about medical equipment and staff availability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
References:
Clinical trial NCT00859807: A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Official title: A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Falciparum Malaria
Keywords: Amodiaquine suspension
Flavoquine tablets
Bioequivalence study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: Cmax, AUCtlast and AUCinf for amodiaquine.
timeFrame: end of study
Secondary outcomes:
measure: Cmax and AUC72 for DesethylAQ
timeFrame: end of study
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04700007: Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine (Second Sub-Project)
Official title: Effect of Intradermal Morphine Application on Histaminergic and Non-histaminergic Itch and Related TRPV1 and Antihistamine Treatments (2nd Sub-project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of our 2nd sub-project is to clarify if the capsaicin receptor TRPV1 is implicated in the mechanism of morphine-induced mast cell degranulation. Moreover, we also aim to clarify if the mechanism of opioid-induced itch relay on the histaminergic pathway by using the antihistamine (diphenhydramine) to suppress the release of histamine from peripheral mast cells.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other addictive drugs
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids.
* Participants with known allergy/discomfort to the opioid morphine and antihistamine.
* Skin diseases
* Moles, scars or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Primary outcomes:
measure: Measuring itch intensity by computerized Visual Analog Scale Scoring
timeFrame: For 10 minutes
measure: Measuring pain intensity by computerized Visual Analog Scale Scoring
timeFrame: For 10 minutes
measure: Superficial blood perfusion measurement
timeFrame: After 15 minutes
Secondary outcomes:
measure: While size
timeFrame: After 15 minutes
Other outcomes:
Locations:
city: AAlborg
country: Denmark
facility: Mech-Sense, Medicinsk Gastroenterologisk ambulatorium, Medicineshus, Aalborn Universitethospitalet
state: Nordjylland
Study officials:
References: