louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01374295: Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge
Official title: Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. After education, patient completes a survey, estimated to take 5 minutes to complete.

Detailed description: The purpose of this study is to compare different methods of teaching patients about their prescription medicines. It is possible that certain teaching methods are better than others at educating patients.

Patients who receive Lortab medication or prescription during their ED visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. After the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. This takes approximately five minutes and asks the patient to rate the quality of the information received.

Eligibility criteria: Inclusion Criteria:

* non-critical emergency room patients being prescribed Lortab
* age 18 year or older

Exclusion Criteria:

* emergency room patients not receiving Lortab as their first prescribed medication
* age less than 18 years

Primary outcomes:
measure: patient satisfaction and knowledge
timeFrame: survey is completed immediately after education, estimated time to complete survey is 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
Clinical trial NCT06808295: Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients
Official title: Dexmedetomidine As an Effective Drug in Reducing Anesthetic Requirements in Patients Undergoing External Dacrocystorhinostomy, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Patients Undergoing External Dacrocystorhinostomy Operations
Assess Decreased Anesthetic Requirements Intraoperative
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 Groups, Dexmedetomidine group and control group are assigned
Primary purpose: OTHER

Brief summary: Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and postoperative

Detailed description: Dexmedetomidine is a highly selective alpha 2 adrenoceptor agonist, having characteristics of natural sleep like sedation, can reduce pain intensity and opioid consumption without influencing the time of recovery from general anesthesia

Eligibility criteria: Inclusion Criteria:

patients of both sexes 16 years to 75 years of age ASA (American society of Anesthesiologists) I-III

Exclusion Criteria:

* Pediatric age group
* ASA more than III

Primary outcomes:
measure: Maintained hemodynamic values while reducing the anesthetic requirements
timeFrame: from 20 minutes after administering the drug till 2 hours after full recovery
Secondary outcomes:
measure: Delerium
timeFrame: from 20 minutes after administering the drug till 2 hours after full recovery
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmolgy
Study officials:
References:
Clinical trial NCT01484795: Noninvasive Ventilation in Acute Myocardial Infarction
Official title: Non Invasive Ventilation in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myocardial Infarction
Keywords: noninvasive ventilation
autonomic nervous system
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major cause of mortality and morbidity in the world. The myocardial ischemia is often the precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive pressure has been used as a therapeutic modality.

Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory and hemodynamic variables in patients with myocardial infarction.

Materials and methods: ten patients with acute myocardial infarction, with Killip I classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will be registered and electrocardiogram signals will be recorded for posterior analyses of HRV. Data will be collected before, during and after positive pressure ventilation.

Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed by Tukey test.

Detailed description: The patients will be recruited in Bonsucesso Federal Hospital with diagnosis of myocardial infarction, confirmed by electrocardiogram and cardiac enzymes, between 24 and 72 hours after the event.

Participation in the study protocol will be done according to eligibility criteria:

The study will be a randomized and crossover clinical trial for evaluation and comparison of heart rate variability and ventilatory and hemodynamics variables during ventilation with CPAP and Bilevel.

CPAP will be applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O. Bilevel will be applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.

Eligibility criteria: Inclusion Criteria:

* acute myocardial infarction with Killip I classification, hemodynamic stability, between 24 and 72 hours post event;
* agreement to participate in the study, according written informed consent;
* 45 to 80 years old age.

Exclusion Criteria:

* unstable angina;
* systolic blood pressure \< 80 mmHg;
* patients who presented ST elevation \> 2 mm or with second-degree atrioventricular block;
* presence of pacemaker.

Primary outcomes:
measure: evaluate HRV during NIV after acute myocardial infarction
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Cristina M Dias, PT - PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05934695: Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors
Official title: The Impact of Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Cancer Female
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to recruit women with different severity levels of breast cancer-related lymphedema, an upper limb condition that can result from breast cancer treatment causing swelling and other impairments. By assessing women at different points along the continuum of lymphedema severity, the impact of severity on shoulder function and related outcomes can be examined.

Brief summary: Breast cancer-related lymphedema (BCRL) is a common complication affecting the upper extremity following breast cancer treatment. This study aims to investigate the relationship between lymphedema severity and shoulder joint function and muscle activation patterns in breast cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Female
* Adults (18 years or older)
* Diagnosis of breast cancer-related lymphedema for a minimum of 3 months
* No current evidence of active cancer
* Able to provide informed consent

Exclusion Criteria:

* Pre-existing musculoskeletal conditions affecting the upper extremities (e.g. adhesive capsulitis, rotator cuff tear)
* Previous upper extremity surgery
* Physical inability to perform the required physical movements and assessments

Primary outcomes:
measure: Shoulder joint mobility
timeFrame: baseline
measure: Muscle activation patterns (Amplitude)
timeFrame: baseline
measure: Muscle activation patterns (Timing)
timeFrame: baseline
Secondary outcomes:
measure: Shoulder flexors strength
timeFrame: baseline
measure: Shoulder abductor strength
timeFrame: baseline
measure: Self-reported upper extremity function
timeFrame: baseline
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT01642095: Studying Biomarkers in Samples From Younger Patients With Kidney Cancer
Official title: Focal Adhesion Kinase Expression in Pediatric Renal Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Childhood Kidney Neoplasm
Clear Cell Renal Cell Carcinoma
Congenital Mesoblastic Nephroma
Rhabdoid Tumor of the Kidney
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-07-17
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE

Brief summary: This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.

OUTLINE:

Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.

Eligibility criteria: Inclusion Criteria:

* Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:

  * Anaplastic Wilms tumor
  * Malignant rhabdoid tumor of the kidney
  * Clear cell sarcoma of the kidney
  * Mesoblastic nephroma

Primary outcomes:
measure: FAK expression in pediatric renal tumors
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Elizabeth Beierle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05465395: Upper Cervical and Thoracic Chiropractic Adjustment
Official title: Effects of Upper Cervical and Thoracic Chiropractic Adjustments on the Autonomic Nervous System and Perceived Stress Response
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stress
Keywords: Heart Rate Varability
Autonomic Nervious System
Chiropractic Adjustment
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Autonomic tests such as HRV, GSR, and the stress surveys will be the primary method of measurement. CareTaker and Biopac devices will provide continual data collection of ECG (for HRV analysis) and GSR throughout the exam and adjustment. Participant's subjective stress levels will be measured through the use of stress questionnaires including the National Stressful Events Survey Acute Stress Disorder Short Scale, the Hamilton Anxiety Rating Scale, and the Connor-Davidson Resilience Scale. The objective of the study is to determine if the location of a chiropractic adjustment will affect the autonomic nervous system in such a way that PNS or SNS activation increases or decreases after the adjustment. Further, the study will continue to examine how the chiropractic adjustment affects the subjective stress response.


Eligibility criteria: Inclusion Criteria:

* Over the age of 19
* In good health
* Willing to have blood pressure taken
* Willinig to shave a small area of chest hair for placement of a ECG patch
* Consent to a physical exam
* Consent ot chiropractic evaluationa nd 2 adjustments

Primary outcomes:
measure: Caretaker Heart Rate Variability
timeFrame: Through study completion, an average of 1 week
measure: Galvanic Skin Response
timeFrame: Through study completion, an average of 1 week
measure: Hamilton Anxiety Rating Scale
timeFrame: Through study completion, an average of 1 week
measure: NSESSS
timeFrame: Through study completion, an average of 1 week
measure: CD-RISC-25
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life Univeristy
name: Stephanie Sullivan
role: STUDY_DIRECTOR
References:
Clinical trial NCT06024395: A Stepped Care Approach to Treating Dental Fear
Official title: A Stepped-Care Approach to Treating Dental Fear: A Sequential, Multiple Assignment, Randomized Trial for Cognitive-Behavioral Treatment Via Mobile App and Evidence-Based Collaborative Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Fear
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2023-09-06
Enrollment: 1250
Sex: ALL
Minimum age (years): 13
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants' dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light touch' intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear.

This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study.

For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.


Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent/ assent form
* Willing to comply with all study procedures and be available for the duration of the study
* Be least 13 years old.
* Score 4 or above on the Gatchel single-item dental fear rating scale
* Willingness to allow access to dental attendance records
* Access to a smartphone or tablet

Exclusion Criteria:

Given the scope and nature of the study, there is no exclusion criteria.

Primary outcomes:
measure: Reduction of moderate to severe dental fear.
timeFrame: baseline, upto 8 weeks, 5/6 month follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Richard Heyman, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mark Wolff, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813395: Laser Therapy on Neuromuscular Performance
Official title: Immediate Effects of Low-level Laser Therapy (808nm) on Neuromuscular Performance After Muscle Fatigue: Randomized-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on neuromuscular performance in healthy subjects after an induced muscle fatigue protocol. Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a preliminary evaluation using surface electromyography and isokinetic dynamometer of the flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after interventions.


Eligibility criteria: Inclusion Criteria:

* Being between 18-28 years of age, having no pain in the shoulder area, elbow or hand, and not having suffered any to injury to the assessed upper limb in the last six months.

Exclusion Criteria:

* Presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.

Primary outcomes:
measure: Peak torque normalized by body weight
timeFrame: Change from baseline to one hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
References:
Clinical trial NCT02648295: Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
Official title: Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Post Total Hip and Knee Arthroplasty
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults undergoing primary total hip and knee arthroplasty

Brief summary: Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.


Eligibility criteria: Inclusion Criteria:

* Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement
* 40-90 years old

Exclusion Criteria:

* Known coagulopathy
* History of venothrombotic event
* Unstable angina
* Recent Myocardial infarction (MI)
* History of bleeding events
* History of chronic anemia
* Preoperative anemia
* Current use of blood thinners including aspirin

Primary outcomes:
measure: All time measurements which indicate various aspects of clotting cascade
timeFrame: 3 months
Secondary outcomes:
measure: Blood loss and transfusions
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01905995: Basal Ganglia Local Field Potentials in Gait and Speech
Official title: Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basal Ganglia Diseases
Keywords: deep brain sitimulation
local field potentials
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Lueneburg Heritage
First posted: 2013-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced Parkinson's disease

Brief summary: Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc).

Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.


Eligibility criteria: Inclusion Criteria:

* good levodopa response

Exclusion Criteria:

* dementia

Primary outcomes:
measure: Difference of frequency spectrum of basal ganglia local field potentials during gait and speech
timeFrame: 1 year
Secondary outcomes:
measure: Evidence for the benefit of different stimulator settings for gait and speech
timeFrame: one year
Other outcomes:
Locations:
city: Munich/München
country: Germany
facility: Dept. of Neurology, Ludwig-Maximilians University of Munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Kai Bötzel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: