louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04124289: A Functional Pain Scale to Improve the Patient Experience
Official title: A Pilot Study to Validate a Functional Pain Scale in Order to Improve the Patient Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Measurement
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for orthopedic surgery procedures who will be assessed for pain

Brief summary: This will be an observational cohort study to evaluate pain measurement after surgery using a new functional pain scale.

Detailed description: Patients admitted for orthopedic surgery may take part in this research. Participants will be assessed using three different pain scales: numeric rating scale (NRS), FACES pain scale and a new functional pain scale (FPS).

Eligibility criteria: Inclusion Criteria:

* Completed orthopedic (hip or knee) surgery
* English as primary language and able to read
* Low risk as assessed by Opioid Risk Assessment Tool (ORAT)
* No history of opioid abuse
* Patients with a diagnosis of chronic pain other than the scheduled hip or knee meeting the above criteria may be included.

Exclusion Criteria:

* Previous diagnosis of cognitive impairment

Primary outcomes:
measure: Change in pain score using functional pain scale questionnaire
timeFrame: Through study completion, an average of 4 days.
measure: Change in pain score using FACES pain scale
timeFrame: Through study completion, an average of 4 days.
measure: Change in pain score using numeric 0-10 rating scale
timeFrame: Through study completion, an average of 4 days.
measure: Change in functionality
timeFrame: Through study completion, an average of 4 days.
Secondary outcomes:
measure: Patient preference for ease of use of the three pain scales (functional, FACES or numerical)
timeFrame: Through study completion, an average of 4 days.
measure: Provider preference for ease of use of the three pain scales (functional, FACES or numerical)
timeFrame: Through study completion, an average of 4 days.
measure: Opioid administration
timeFrame: Through study completion, an average of 4 days
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Harris W Thomas, BSN, RN-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398189: F-18 Altanserin PET Study of Patients Receiving Clozapine
Official title: Validation of Molecular Imaging Technologies for Early Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: clozapine
PET
schizophrenia
schizoaffective disorder
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Detailed description: Clinical evaluation of patients with psychiatric disorders is mainly dependent on patients' reports and clinicians' observations. In order to develop objective and quantifiable measures of psychopathology, molecular imaging techniques will be used in patients receiving clozapine.

Eligibility criteria: Inclusion Criteria:

* Overtly healthy males as determined by medical history and physical examination
* Age from 19 to 45 years
* Weight ≥ 45 kg and within ± 20% of IBW
* Clinical laboratory test results within normal reference range for the National Cancer Center, Hospital or results with minor deviations which are judged to be not clinically significant by the investigator
* Normal blood pressure and heart rate (supine and standing) as determined by the investigator
* Are reliable and willing to make themselves available for the duration of the study, and who will abide by the study restrictions
* Have given written informed consent

Exclusion Criteria:

* Evidence of significant active hematologic disease
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
* An episode of febrile disease or infectious disease within the past 2 weeks
* Evidence of significant active neuropsychiatric disease
* Regular use of drugs or abuse
* History of drug hypersensitivity or clinically significant allergic reactions of any origin
* Participation in a study involving administration of an investigational compound within the past 30 days
* Use of any current medication
* Smoking history for recent 3 months

Primary outcomes:
measure: pharmacodynamics of F-18 artanserin
timeFrame: 84 days
Secondary outcomes:
measure: serum level of clozapine and metabolites
timeFrame: 84 days
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Seung Chang, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00627289: Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain
Official title: The Effect of Selective Neurectomy and Mesh Removal on Chronic Postherniotomy Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Chronic pain
groin hernia
neuropathic pain
chronic postoperative pain
Postherniotomy pain
Neuroplastic changes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-03-03
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: Patients with chronic pain occuring after groin hernia repair. Patients must experience moderate/severe pain related impairment of everyday activities. Patients have to be able to localize a maximum point of pain.

Brief summary: Chronic postherniotomy pain affects every day activities in 5-8% of patients. However, no established treatment for this pain syndrome exists and previous reports on the effect of surgical intervention suffer from methodological problems. The neurophysiological characteristics suggest that pain arises from deeper neuronal structures injured during surgery or by ongoing inflammation from the mesh. This study investigates the effect of removing inserted mesh and compressed nerves on pain related daily impairment of activities assessed by the validated AAS questionnaire before and 6 months after surgery


Eligibility criteria: Inclusion Criteria:

* Adult ( more than 18 years old) patients with chronic pain after groin hernia surgery, and pain related impairment of everyday function. The pain should have occurred after previous open surgery.
* The patient should be able to locate to a specific area with maximum pain. Patients should be able to understand and use pain scales, and the AAS-scale.

Exclusion Criteria:

* All that contradicts the above

Primary outcomes:
measure: changes in AAS scores before and six months after operation
timeFrame: 6 months
Secondary outcomes:
measure: changes in sensory function assessed by quantitative sensory testing
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hørsholm
country: Denmark
facility: Ambulatory Surgical Clinic, Hørsholm Hospital
Study officials:
affiliation: Rigshospitalet, Copenhagen University, Denmark
name: Eske K Aasvang, M.D.
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Copenhagen University, Denmark
name: Henrik Kehlet, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.
Clinical trial NCT03363789: The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis
Official title: A Prospective Clinical Trial Comparing the Efficacy of Brisement to Physical Therapy for the Treatment of Achilles Tendinosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Achilles Tendinopathy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of ultrasound guided brisement, brisement without ultrasound guidance and standard conservative treatment in patients who have been diagnosed with Achilles tendinosis. We are asking you to take part in this research study because you are a patient of the Brigham Foot and Ankle Clinic who has been diagnosed with Achilles tendinosis. About 100 people will take part in this research study, all at Brigham and Women's Hospital (BWH).

To our knowledge, there has been very little research in the efficacy of the addition of briesment injections to standard, conservative treatment of Achilles tendinosis. We hope our results will show which method is the most effective conservative treatment for Achilles tendinosis. This information will help doctors make decisions in the future.


Eligibility criteria: Inclusion Criteria:

* All patients enrolled in the study must have a diagnosis of Achilles tendinosis with at least 2 weeks of pain at the distal Achilles tendon which is typically worsened with activity. Only cases of non-insertional Achilles tendinosis (tendinosis occurring above the point of tendon insertion) will be included.

Exclusion Criteria:

* Patients with a prior Achilles tendon tear, chronic inflammatory disease, or history of posterior calf surgery will be excluded from the study. Additionally, patients with prior injuries or fractures to the ankle and hind foot (talus and calcaneus) requiring surgery will be excluded.

Primary outcomes:
measure: VISA - A
timeFrame: 3 months
Secondary outcomes:
measure: PROMIS
timeFrame: 6 weeks, 3 months, 6 months, 1 year
measure: VAS Pain Scale
timeFrame: Weekly for 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher Chiodo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113189: Impact of Walking Practice on Persons With PD
Official title: The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: gait
Parkinson's disease
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
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 investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.

Detailed description: This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
2. Age between 30 and 90.
3. Ability to walk 150 feet independently over level surfaces with or without an assistive device.
4. Hoehn and Yahr stage 1-4.
5. Less than 10 full heel raises in single limb stance bilaterally.
6. Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.

Exclusion Criteria:

1. Body mass index greater than 40.
2. Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
3. Any other uncontrolled health condition for which gait training is contraindicated

Primary outcomes:
measure: Change in Distance Walked on 6-Minute Walk Test (6MWT)
timeFrame: 6MWT will be done at initial testing and 12 months
Secondary outcomes:
measure: Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
timeFrame: Testing will be done at initial testing and 12 months
Other outcomes:
measure: Change in Daily Activity as Measured by Steps Per Day
timeFrame: Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory
state: Texas
Study officials:
affiliation: UTSW Medical Center
name: Karen J McCain, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01769989: Electrodermabrasion Compared to Dermabrasion
Official title: Evaluation of the Safety and Efficacy of Electrodermabrasion in Improving the Appearance of Scars That Result From Dermatologic Surgery Compared to Treatment With Dermabrasion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if electrodermabrasion improves the cosmetic appearance of raise or bumpy scars or scars that are a different color or texture than the surrounding skin resulting from dermatologic surgery and whether it is as good as to the already used method of dermabrasion.


Eligibility criteria: Inclusion Criteria:

* Not incarcerated
* No mental impairments that could potentially interfere with the subject's ability to understand the various scar revision modalities and their potential risks and benefits, and thereby ability to provide informed consent
* No bleeding disorders
* A patient at UC Davis Medical Center's Department of Dermatology who has undergone a dermatologic surgery procedure and is not satisfied with the appearance of his/her scar

Exclusion Criteria:

* Incarcerated
* With mental impairment(s) that could potentially interfere with subject's ability to understand the various scare revision modalities and their potential risks and benefits, and thereby ability to provide informed consent
* With a bleeding disorder
* With any other contraindication to the treatment used in the study
* Not a patient at UC Davis Medical Center's Department of Dermatology
* Subjects who are not willing or able to return for follow-up assessments
* Subjects who are not able to give informed consent to enter the study
* Subjects who are not willing to complete the visual analog scale following treatment

Primary outcomes:
measure: Electrodermabrasion compared to dermabrasion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04264689: Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
Official title: Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 51
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: PREVENTION

Brief summary: the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries

Detailed description: comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects

Eligibility criteria: Inclusion Criteria:

* patients scheduled for thoracotomy age 18-65

Exclusion Criteria:

* patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases

Primary outcomes:
measure: visual analogue score
timeFrame: 24 hours
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of anesthesia and pain medicine. National Cancer Institute
Study officials:
affiliation: Lecturer
name: walaa Y elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576289: Analysis of Biopsies From the Upper Gastrointestinal Tract
Official title: Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Gastritis
Keywords: Esophagus
Gastroesophageal reflux
Reflux esophagitis
Barrett's esophagus
Stomach
Intestinal metaplasia stomach
Helicobacter pylori infection
Proton pump inhibitor
Duodenum
Duodenal bulb
Celiac disease diagnosis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 600
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who routinely undergo upper endoscopy (for different, not selected reasons)

Brief summary: Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.

Detailed description: Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history.

The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology.

Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.

Eligibility criteria: Inclusion Criteria:

* none

Exclusion Criteria:

* Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University
Study officials:
affiliation: Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria
name: Cord Langner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483989: In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients
Official title: In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Epithelial changes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 19
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 study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

Detailed description: The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Eligibility criteria: Inclusion Criteria:

Subjects must have history of dry eye as determined by:

1. Questionnaire
2. Tear Film Break Up Time less than or equal to 10 seconds
3. Schirmer's score of less than or equal to 5 mm
4. Corneal staining greater than or equal to 3 in either eye, and
5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion Criteria:

* Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

Primary outcomes:
measure: Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
timeFrame: baseline and 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: http://iovs.arvojournals.org/article.aspx?articleid=2351788