louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05362721: PV Loop & Coarctation Study
Official title: Assessment of the Impact of Transcatheter Stenting of Aortic Coarctation on the Left Ventricular Afterload and Work Using Left Ventricular Pressure Volume Loops
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coarctation of Aorta
Keywords: Coarctation of Aorta
COA
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for elective cardiac catheterization and stent therapy for coarctation

Brief summary: Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.


Eligibility criteria: Inclusion Criteria:

* Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation
* Those who provide informed consent for study participant.

Exclusion Criteria:

* Children who undergo other interventions in addition to the coarctation
* Children with single ventricle physiology.
* Renal impairment
* Participant unwilling to sign a consent form.

Primary outcomes:
measure: Change in left ventricular afterload measured by arterial elastance
timeFrame: Immediately following intervention
Secondary outcomes:
measure: Change in left ventricular performance measured by ESPVR
timeFrame: Immediately following intervention
measure: Change in left ventricular work as measured by Stroke Work
timeFrame: Immediately following intervention
measure: Change in left ventricular efficiency as measured by ventricular arterial coupling
timeFrame: Immediately following intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: University of Texas-Southwestern
state: Texas
Study officials:
affiliation: University of Minnesota
name: Gurumurthy Hiremath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05104021: Environmental Game After Appendicitis Surgery
Official title: The Effect of Mobilization of Environmental Play on Fear and Pain Levels in the Postoperative Period Between 6-12 Years Old Children With Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Pain
Fear
Pediatric surgery
Game
Appendicitis
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Kanuni Sultan Suleyman Training and Research Hospital
First posted: 2021-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study was conducted to determine the effect of environmental play and mobilization on fear and pain levels of children aged 6-12 years who had acute appendicitis surgery.

Detailed description: It was conducted with children aged 6-12 years in the postoperative period in a randomized controlled manner. Children in the intervention (n:50) group were mobilized by playing environmental games.The children in the control group (n:50) underwent routine mobilization of the clinic.

The data were collected with the "Child Follow-up Form", which was created to evaluate the child's demographic characteristics, physiological parameters, pain and fear.

Eligibility criteria: Inclusion Criteria:

* Being between 6-12 years old,
* Being open to communication and cooperation,
* No visual or hearing impairment,
* Appendectomy surgery,
* First mobilization after surgery.
* Parent's willingness to participate in the study can be sorted.

Exclusion Criteria:

* Having a mental or neurological disability,
* Children with hearing and vision impairment

Primary outcomes:
measure: The effect of environmental play on premobilization pain score of children
timeFrame: 30 seconds
measure: The effect of environmental play on the postmobilization pain score of children
timeFrame: 30 seconds
measure: The effect of environmental play on children's fear score before mobilization
timeFrame: 30 seconds
measure: The effect of environmental play on children's fear score after mobilization
timeFrame: 30 seconds
measure: The effect of environmental play on the pulse rate of children before mobilization
timeFrame: 60 seconds
measure: The effect of environmental play on the pulse rate of children after mobilization
timeFrame: 60 seconds
measure: The effect of environmental play on the blood pressure of children before mobilization
timeFrame: 60 seconds
measure: The effect of environmental play on the blood pressure of children after mobilization
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Istanbul okan university
state: Istanbul
Study officials:
References:
Clinical trial NCT04091321: Association Between Chronic Headache and Back Pain With Childbirth
Official title: Association Between Chronic Headache and Back Pain With Childbirth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache Disorders, Secondary
Post-Dural Puncture Headache
Migraine Disorders
Back Pain
Anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 1112
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pain patients who have elected to be contacted for research studies

Brief summary: This study uses a single questionnaire to evaluate two separate primary outcomes:

1. To identify association between chronic headache in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them
2. To identify association between chronic back pain in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them

Detailed description: Chronic headache and back pain have an excess prevalence in women as compared to men. This study uses a single survey that uses logic to assess for association between childbirth and chronic headache and between childbirth and chronic back pain using screening questions. The questions are, "Do you suffer from chronic headaches" and "Do you suffer from chronic back pain". Depending on the answer to the screening question, the subject will be given further questions only related to the syndrome that they endorsed.

Arm 1) There is an association between chronic headache and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of headache and childbirth, association between migraine headache and childbirth, association between chronic headache and anesthetic complications.

Arm 2) There is an association between chronic back pain and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of back pain and childbirth, association between chronic headache and anesthesia.

Eligibility criteria: Inclusion Criteria:

* Female representation

Exclusion Criteria:

* None

Primary outcomes:
measure: Chronic headache
timeFrame: 10 minute questionnaire
measure: Chronic back pain
timeFrame: 10 minute questionnaire
Secondary outcomes:
measure: Migraine
timeFrame: 10 minute questionnaire
measure: Temporal coincidence of headache and childbirth
timeFrame: 10 minute questionnaire
measure: Temporal coincidence of headache and dural puncture
timeFrame: 10 minute questionnaire
Other outcomes:
measure: Temporal coincidence of back pain and regional anesthesia
timeFrame: 10 minute questionnaire
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT02030821: TXA vs. Amicar in Total Knee and Hip Arthroplasty
Official title: TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Hip Arthritis
Knee Arthritis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 246
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: The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty.

Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay.

Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.

A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.


Eligibility criteria: Inclusion Criteria:

* Patients electing to undergo primary total hip or knee arthroplasty

Exclusion Criteria:

* History of stents
* Myocardial infarction,
* Cerebrovascular accident or stroke
* Deep venous thrombus
* Pulmonary embolus
* Late onset color blindness
* Hypercoagulable state

Primary outcomes:
measure: Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Number of Transfusions
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Difference in Preoperative and Lowest Postoperative Hemoglobin
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Length of Hospitalization Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Cost of Hospitalization
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT06762821: A 24-month Outcomes of Single- Vs Multiple-visit Revascularization
Official title: Clinical and Radiographic Outcomes of Single- Versus Multiple-visit Revascularization of Asymptomatic Necrotic Immature Maxillary Permanent Incisors: a 24-month Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Necrotic Immature Permanent Incisors
Keywords: single-visit
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 86
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.


Eligibility criteria: Inclusion Criteria:

* Compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment.
* Patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination.
* Patient without previous endodontic treatment in affected tooth.

Exclusion Criteria:

* Patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult.
* Patients taking medications that can interfere with healing or hemostasis.
* Patients with allergy to local anesthetics
* Children who will not comply to recall program.
* Teeth with extensive loss of coronal tissue that require restoration with a post
* Teeth with internal or external root resorption

Primary outcomes:
measure: Number of Participants experiencing Pain after treatment
timeFrame: From enrollment to the end of treatment at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Dental Hospita
Study officials:
References:
Clinical trial NCT04610164: The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy
Official title: The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Shoulder Arthroscopy
Operative Bleeding
Postoperative Pain
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.


Eligibility criteria: Inclusion Criteria:

* participants aged 18-80
* participants with an ASA (American Society of Anesthesiologists) score 1-3
* participants with a surgical indication of full thickness small to massive rotator cuff tear.

Exclusion Criteria:

* pregnant females,
* participants with a known allergy to tranexamic acid,
* participants with active thromboembolic disease,
* participants with seizure disorder,
* participants with prior cerebrovascular accident (CVA),
* history of cardiac stents or past history of thromboembolic disease,
* presence of full-thickness subscapularis tear (\>50%),
* participants with irreparable rotator cuff tears.

Primary outcomes:
measure: Changes in operative factors
timeFrame: 2 hours
measure: Postoperative pain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00935064: The Effect of Renin Inhibition on Nerve Function in Diabetes
Official title: Effect of Renin Inhibition on Cardiovascular Autonomic Nerve Function in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 60
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: This study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., \[1\] 30 participants enrolled and randomized to 300 mg of Aliskiren; \[2\] 30 participants enrolled and randomized to placebo).


Eligibility criteria: Inclusion Criteria:

* Individuals \>18 years old with type 1 or type 2 diabetes mellitus.

Exclusion Criteria:

* Individuals currently taking the maximum dose of an ACE inhibitor or an ARB.
* Individuals with a history of a MI, percutaneous coronary interventions, coronary artery bypass graft (CABG) surgery, acute coronary syndromes, recent/on going atrial fibrillation, frequent atrial arrhythmias, frequent ventricular arrhythmias, or acute myocardial ischemia changes.
* Individuals whose treatment dosage changes 2 months prior to the study for antihypertensive and antidiabetes medications, and the following medications that may affect the ANS: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic, antiparkinsonism drugs, and nitrated drugs.
* Pregnant or lactating females.
* Individuals with impaired renal function (i.e., creatinine \>1.5 mg/dl), a history of dialysis, nephritic syndrome or renovascular hypertension.
* Individuals with potassium levels within 0.5 mmol/L of the upper limit of normal (i.e., hyperkalemia).

Primary outcomes:
measure: Systolic Blood Pressure Before and After Treatment
timeFrame: baseline and 6 weeks
measure: Diastolic Blood Pressure Before and After Treatment
timeFrame: baseline and 6 weeks
measure: Serum Renin Level Before and After Treatment
timeFrame: baseline and 6 weeks
measure: Mean Circular Resultant Before and After Treatment
timeFrame: baseline and 6 weeks
measure: Expiration/Inspiration Ratio Before and After Treatment
timeFrame: baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
affiliation: University of Delaware
name: Raelene E Maser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224964: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
Official title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthmatic Patients
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 1
Sex: ALL
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 main objectives of the study are:

1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists)

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.
3. These subgroups have different responses to anti-leukotrienes.


Eligibility criteria: Inclusion Criteria:

* uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)

Exclusion Criteria:

* viral/fungal/bacterial infection +fever (\<1 month)
* asthma exacerbation (\<3 months)
* other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
* cardiac patients using beta-blockers

Primary outcomes:
measure: sputum cytokine mRNA
timeFrame: 8 weeks
Secondary outcomes:
measure: responsiveness to the medication
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Dominique MA Bullens, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Sven F Seys, MSc
role: STUDY_DIRECTOR
References: