louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04901507: Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Official title: Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Voutia
First posted: 2021-05-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the effectiveness of treating dry mouth through water rehydration using this extra oral water pump/irrigation device.

Detailed description: Dry mouth causes difficulty with chewing, swallowing, speech, and increases the risk dental cavities. It also can cause discomfort in the mouth, and a loss of general quality of life. The oral irrigation device supplies a small amount of water to participant's mouth through a small tube that is placed in the corner of the mouth throughout the time participants wear it.

In this study, participants will be asked to:

1. Visit the dental school clinic two (2) times for study visits.
2. Wear the oral irrigation device as directed by the investigator.
3. Keep notes at home.
4. Answer survey questions during both dental visits about dry mouth symptoms.
5. Give permission for the researchers to collect information about medications or health conditions that contribute to dry mouth from participant's medical records.

Eligibility criteria: Inclusion Criteria:

* patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands

Exclusion Criteria:

* Patient who after testing do not exhibit salivary hypofunction
* Children
* Patient with limited English proficiency

Primary outcomes:
measure: Change in Oral Health Related Quality of Life (OHRQoL)
timeFrame: Baseline to 4 - 6 weeks
measure: Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)
timeFrame: Baseline to 4 - 6 weeks
measure: Change in Oral Dryness
timeFrame: Baseline to 4 - 6 weeks
measure: Clinical Changes in Stimulated Saliva Flow
timeFrame: Baseline to 4 - 6 weeks
measure: Clinical Changes in Unstimulated Saliva Flow
timeFrame: Baseline to 4 - 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Susie Goolsby, DDS, MSHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821807: Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
Official title: Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section, Two Different Needles.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Adverse Effect, Spinal and Epidural, Headache
Complications; Anesthesia, Spinal and Epidural, in Pregnancy
Keywords: spinal anesthesia
spinal needle
cesarean section
headache
backache
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant female patients between 18-40 years old undergoing cesarean section in Adiyaman University Research Hospital, Turkey.

Brief summary: The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.

Two kind of spinal anesthesia needles will be used:

1. 26 Gauge Quincke (cutting-tip needle)
2. 26 Gauge Atraucan (atraumatic needle)

The investigators will observe:

1. Number of spinal punctures
2. Time required for the spinal anesthesia procedure

Patients will be evaluated after 7 days for:

1. Headache
2. Backache

Detailed description: It is a known phenomenon that spinal anesthesia sometimes results in headache.

The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.

Two kind of spinal anesthesia needles will be used:

1. 26 Gauge Quincke (cutting-tip needle)
2. 26 Gauge Atraucan (atraumatic needle)

We will observe:

1. Number of spinal punctures
2. Time required for the spinal anesthesia procedure

Patients will be evaluated after 7 days for:

1. Headache
2. Backache

2 kind of spinal anesthesia needles will be used, but no comparison will be made. This is an observational study. Although literature gives different rates of postdural puncture headache for these two needles, we observe the same rate of headache in our clinical practice. We want to define the real rate of postdural puncture headache in patients undergoing cesarean section with spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* Pregnant female patients between 18-40 years old undergoing cesarean section
* Patient accepting spinal anesthesia

Exclusion Criteria:

* Infection at the spinal needle insertion cite
* Coagulability disorder
* Patient not accepting the procedure

Primary outcomes:
measure: Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section
timeFrame: 1 week
Secondary outcomes:
measure: Backache in Patients Receiving Spinal Anesthesia for Cesarean Section
timeFrame: 1 week
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University Research Hospital
Study officials:
affiliation: Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00495807: Nurses' Negative Words and Postoperative Pain Management
Official title: Influence on Pain Management of Nurses' Negative Words After Total Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Psychological Tests
Pain, Postoperative
Nurses
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Confidential Enquiry into Maternal and Child Health
First posted: 2007-07-03
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Psychological implications expressed pivotal effects on daily activities. Postoperative pain management is always encountered varying influence from the ambience of surgical wards, especially the nurses. We hypothesized that nurses' negative or positive words would produce unexpected role in pain management, which might be a strong factor resulting in the failure of postoperative analgesia.


Eligibility criteria: Inclusion Criteria:

* Chinese
* Abdominal Surgery
* \> 18yr \< 65yr
* Female
* Administration of postoperative analgesia
* Patient-controlled analgesia

Exclusion Criteria:

* With cardiac or/and pulmonary diseases
* Allergy to Opioids
* \> 20% alteration in vital signs
* Unwilling to finish the follow-up process
* Respiratory depression
* \> = 65yr = \< 18yr
* Non-Chinese

Primary outcomes:
measure: Visual Analog Scale of Pain
timeFrame: 0h to 48h after operation
Secondary outcomes:
measure: Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions
timeFrame: 0-48h after surgeries
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References:
citation: Wang F, Shen X, Xu S, Liu Y, Ma L, Zhao Q, Fu D, Pan Q, Feng S, Li X. Negative words on surgical wards result in therapeutic failure of patient-controlled analgesia and further release of cortisol after abdominal surgeries. Minerva Anestesiol. 2008 Jul-Aug;74(7-8):353-65.
Clinical trial NCT03903107: The Fluoroless-CSP Trial Using Electroanatomic Mapping
Official title: Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Node Dysfunction
Heart Block AV
LBBB
Heart Failure, Systolic
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

Detailed description: The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device

Exclusion Criteria:

* Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device
* Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
* Pregnancy
* Difficulty with follow-up

Primary outcomes:
measure: Success of achieving CSP
timeFrame: Intra-procedure
Secondary outcomes:
measure: Total radiation exposure time during procedure
timeFrame: Intra-procedure
measure: Procedure-related complications
timeFrame: 30 days post procedure
measure: Need for His Lead revisions
timeFrame: for a period of 6 months post procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Sharma PS, Huang HD, Trohman RG, Naperkowski A, Ellenbogen KA, Vijayaraman P. Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006967. doi: 10.1161/CIRCEP.118.006967.
Clinical trial NCT03045588: The Effects of a Train High, Sleep Low Strategy
Official title: The Effects of a Train High, Sleep Low Strategy on Performance, Substrate Utilization and Muscular Adaptations in Moderately Trained Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cycling Performance
Muscular Adaptations
Substrate Utilization
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Team Denmark
First posted: 2017-02-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators will examine the long-term effects of a combined training and diet intervention that, acutely, increases fat oxidation during exercise. This is done with a 4 week intervention study with moderately trained cyclists. Performance is tested pre and post intervention and muscle biopsies are obtained.


Eligibility criteria: Inclusion Criteria:

* 18-45 years
* VO2-max\>55 ml/kg/min
* No smokers
* Training 6 hours per week (cycling)
* Training experience for more than 3 years.

Exclusion Criteria:

* Less than 2 g carbohydrate/kg/day

Primary outcomes:
measure: Time trial performance measured in Watts
timeFrame: Change from Baseline and after 4 weeks of training
Secondary outcomes:
measure: Protein expression in skeletal muscle tissue
timeFrame: Baseline and after 4 weeks of training
measure: The absolute amount of carbohydrate and fat which is metabolised during morning exercise, measured in grams/minute
timeFrame: Baseline and after 4 weeks of training
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00621088: A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
Official title: A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trochanteric and Subtrochanteric Hip Fractures
Treatment With a New Nail or a Sliding Hip Screw
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures).

Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?


Eligibility criteria: Inclusion Criteria:

* Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.

Exclusion Criteria:

* Patients with pathologic fractures, patients already included with a fracture on the opposite side.

Primary outcomes:
measure: Early postoperative pain (VAS)(and functional mobility (TUG-test))
timeFrame: 1 week postoperative
Secondary outcomes:
measure: Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop.
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Orthopaedic dep, Haukeland University Hospital
Study officials:
affiliation: Orthopaedic Department, Haukeland University Hospital
name: Kjell Matre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06606288: Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
Official title: Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will include all U.S. Medicare beneficiaries enrolled in fee-for-service Medicare implanted with a Medtronic pacemaker between January 1, 2017 and December 1, 2023.

Brief summary: The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous pacemaker, is a safe and effective alternative to biventricular pacing (BVP) in patients indicated for cardiac resynchronization therapy (CRT) to deliver cardiac physiologic pacing (CPP), as documented in the clinical literature.


Eligibility criteria: Inclusion Criteria:

Dual-chamber CSP cohort:

* Medicare beneficiaries implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date.
* Lead type and placement data indicating CSP.
* An indication for CRT.

BVP comparator cohort:

* Medicare beneficiaries implanted with a Medtronic biventricular pacemaker (CRT-P) on or after the study start date.

Exclusion Criteria:

Dual-chamber CSP cohort:

* Evidence of a prior CIED device.
* Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
* Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
* Missing lead type or placement data.
* Lead type and placement data indicating non-CSP placement.

BVP comparator cohort:

* Evidence of a prior CIED device.
* Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
* Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
* Missing lead type or placement data.

Primary outcomes:
measure: Acute complication rate
timeFrame: 30 days
measure: Heart Failure Hospitalization Rate
timeFrame: 12 months
Secondary outcomes:
measure: Device-Related Reintervention Rate
timeFrame: 12 months
measure: Heart Failure-All-Cause Mortality Composite
timeFrame: 12 months
measure: All-Cause Mortality Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Mounds View
country: United States
facility: Medtronic
state: Minnesota
Study officials:
References:
Clinical trial NCT01681888: Surface EMG Biofeedback for Children With Cerebral Palsy
Official title: Clinical Trial of Surface EMG Biofeedback for Children With Cerebral Palsy and Associated Movement Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebral Palsy
Dystonia
Hypertonia
Spasticity
Movement Disorders
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent voluntary movement. Studies have suggested that using biofeedback to increase awareness of muscle activation can improve motor function in patients with motor deficits. The investigators hypothesize that the daily use of a surface electromyographic (SEMG) biofeedback device for one month will improve motor function in children and young adults with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the muscle(s) the subject has difficulty in controlling and provides vibratory feedback about muscle activation. Groups of children and young adults (ages 3-21), with dystonia, hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory feedback device on their affected muscle(s) for 5 hours a day for one month. The device will vibrate and emit a blue light when the muscle is activated. At the start of the experiment, subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one month, subjects will practice goals without device. After a month, subject will be assessed again and be given device to practice goals for a month. After one month, the subjects will be tested on the outcome measures again and return device.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy, or associated movement disorders such as dystonia, spasticity, and/or hypertonia
* Able to wear device for given amount of time

Exclusion Criteria:

* Unable to wear device for at least 5 hours day for a month.

Primary outcomes:
measure: Goal Attainment Scale
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
Study officials:
affiliation: University of Southern California
name: Terence Sanger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408288: Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.
Official title: Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematuria
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses volunteering to take part in the study outside of the urology department of CHU Nimes and a panel of urologist experts

Brief summary: The investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.


Eligibility criteria: Inclusion Criteria:

* The participant is at least 18 year old
* Nurses recruited voluntarily in the CHU Nimes outside of the Urology department of any duration of experience
* Urologist working in the Languedoc-Roussillon region

Exclusion Criteria:

* The participant has color-blindness
* Nurse or urologist from the urology department of Nimes

Primary outcomes:
measure: Intra-user concordance in assessment of hematuria score measured by Hemapoche
timeFrame: Baseline
measure: Intra-user concordance in assessment of hematuria score measured by Hemostick
timeFrame: Baseline
measure: Intra-user concordance in assessment of hematuria described by color of urine
timeFrame: Baseline
Secondary outcomes:
measure: Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche
timeFrame: Baseline
measure: Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick
timeFrame: Baseline
measure: Concordance between nurses versus doctors in assessment of hematuria described by color
timeFrame: Baseline
measure: Time needed to characterize hematuria when using Hemapoche
timeFrame: Baseline
measure: Time needed to characterize hematuria when using Hemostick
timeFrame: Baseline
measure: Time needed to characterize hematuria when using color description
timeFrame: Baseline
measure: Satisfaction of medical staff in using Hemapoche medical device
timeFrame: Baseline
measure: Usability scale of Hemapoche device according to medical staff
timeFrame: Baseline
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Armand Chevrot, MD
role: PRINCIPAL_INVESTIGATOR
References: