louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03389334: Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees
Official title: Effects of Myofascial Release Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this graduate research study is to explore the therapeutic benefits of Myofascial Release massage on lower limb amputees with pain levels, range of motion, and muscle strength.

Detailed description: There are no other studies that address the effects of massage therapy as a treatment option for lower limb amputees suffering from lower back pain or the effects this has on muscle performance and/or range of motion. In addressing the physical, psychological, and social needs of a person living with limb loss, there should be a consideration for a multidisciplinary approach that could potentially include massage therapy as a fundamental standard of care. Therefore, the purpose of this graduate student research study is to test whether myofascial release massage can improve lower back pain levels in lower limb amputees and consequently improve quality of life and other measurable variables such as range of motion and muscle strength.

Eligibility criteria: Inclusion Criteria:

* Pain in the lower back region
* Trans-tibial, trans-femoral, knee disarticulation, or Symes amputees
* Unilateral lower limb amputation
* Subject willing to receive massage once a week over a 4 week span
* Subject must be willing to abstain from over-the-counter and prescription pain medication 24 hours before each treatment

Exclusion Criteria:

* Open wounds within the treatment area
* Bilateral lower limb amputees
* Pregnant subjects (self-reported)
* Lymphedema
* Amputation distal to ankle
* Subjects who currently receive regular massage treatments
* Subjects taking anticoagulant medication
* Subjects with allergies to coconut oil

Primary outcomes:
measure: Low Back Pain
timeFrame: Change in low back pain between baseline and study completion at the fourth week (Visit 4).
measure: visual analog pain scale
timeFrame: Change in visual analog pain scale score between baseline and study completion at the fourth week (Visit 4).
Secondary outcomes:
measure: Range of Motion
timeFrame: Change in range of motion as measured by goniometer between baseline and study completion at the fourth week (Visit 4).
measure: Muscle strength
timeFrame: Change in muscle strength score as measured by the MMT between baseline and study completion at the fourth week (Visit 4).
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University
name: Heather Appling, MSOP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00110734: S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults
Official title: A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia for Laser-Assisted Tattoo Removal in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient elects to undergo laser-assisted tattoo removal

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
* Patient has participated in any previous clinical trial involving S-Caine Peel

Primary outcomes:
measure: To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults
Secondary outcomes:
measure: To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
Study officials:
References:
Clinical trial NCT00265434: Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Official title: Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Chronic Rhinosinusitis
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: PD Dr. Joachim Riethmöller, Tübingen
name: PD Dr. Assen Koitschev, Tübingen
name: Dr. Gerlind Schneider
First posted: 2005-12-14
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of Chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections.

The prospective placebo controlled cross-over study aims at the evaluation of the efficacy of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.


Eligibility criteria: Inclusion Criteria (most important):

* Subject has a confirmed diagnosis of cystic fibrosis.
* Subject has chronic or recurrent rhinosinusitic disorders.
* Subject is 5 years or older.

Exclusion Criteria (most important):

* Subject has a critical condition (FEV1\<30% and SaO2\<93%).
* Subject had an ENT surgery within 6 months prior to study.

Primary outcomes:
measure: Changes in sinonasal symptoms (SNOT-20
timeFrame: 2 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität
state: Thüringen
Study officials:
affiliation: University of Jena
name: Jochen G. Mainz, M.D.
role: STUDY_CHAIR
References:
citation: Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmuller J, Koitschev A, Schneider G, Beck JF, Wiedemann B. Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial. Auris Nasus Larynx. 2011 Apr;38(2):220-7. doi: 10.1016/j.anl.2010.09.001. Epub 2010 Oct 27.
Clinical trial NCT00516334: Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
Official title: Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injury
Seizures
Cerebral Palsy
Keywords: brain
electroencephalography
premature infant
neurodevelopment
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2007-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants \<29 weeks gestational age

Brief summary: This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.

Detailed description: Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.

Eligibility criteria: Inclusion Criteria:

* Infants inborn below 28 weeks gestation

Exclusion Criteria:

* At birth, deemed not likely to survive 7 days or more
* Major intracranial congenital anomaly

Primary outcomes:
Secondary outcomes:
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: Linda J Van Marter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Deirdre O'Reilly, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03203434: Non-invasive Detection of Anastomotic Leakage
Official title: Non-invasive Detection of Anastomotic Leakage Following Esophageal and Pancreatic Surgery by Urinary Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak
Keywords: Pancreatic cancer
Esophageal cancer
volatile organic compounds
Field asymmetric ion mobility spectrometry
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants had suspected malignancies of the esophagus, pancreas, distal bile duct, ampulla Vateri or duodenum and were scheduled for surgery (i.e. esophagectomy or pancreaticoduodenectomy).

Brief summary: Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.


Eligibility criteria: Inclusion Criteria:

* Patients were aged 18-90 years
* American Society of Anesthesiologists (ASA) physical status of 3 or lower
* All participants were capable to understand the study information and signed written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Anastomotic leakage
timeFrame: Postoperatively (30-days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Freek Daams, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03966534: Blood Test Order and Culture Contamination
Official title: A Randomized Controlled Study of Blood Test Draw Order to Reduce Blood Culture Contamination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Culture Contamination
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 970
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective partially blinded randomized study
Primary purpose: PREVENTION

Brief summary: A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Presence in Emergency Room during extended office hours (0800-2000 on weekdays(
* Clinical requirement for Blood culture and biochemistry tests from venepuncture

Exclusion Criteria:

* None

Primary outcomes:
measure: Blood culture contamination
timeFrame: up to 7 days from obtaining blood culture
Secondary outcomes:
measure: Patient length of stay
timeFrame: up to 3 months from arrival
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References:
citation: Zimmerman FS, Karameh H, Ben-Chetrit E, Zalut T, Assous M, Levin PD. Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial. Clin Infect Dis. 2020 Aug 22;71(5):1215-1220. doi: 10.1093/cid/ciz971.
Clinical trial NCT03806634: Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 2)
Official title: Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis, ALS, communication, needs
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with ALS were recruited from ALS clinics(Taipei Veterans General Hospital, Taiwan, R.O.C),20 participants. Participants were eligible for this study if they were diagnosed with definite, probable, probable laboratory-supported, or possible ALS according to the criteria (Brooks et al., 2000).

Brief summary: The research is aimed to asses the validity of the communication system improving the quality of life and the degree of sanctification of clinical patients and their caregiver.


Eligibility criteria: Inclusion Criteria:

* Escorial revised criteria (Brooks et al., 2000),The diagnosis of ALS requires:

(A) the presence of:

* (A:1) evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological or neuropathologic examination (A:2) evidence of upper motor neuron (UMN) degeneration by clinical examination, and
* (A:3) progressive spread of symptoms or signs within a region or to other regions, as determined by history or examination, together with: (B) the absence of (B:1) electrophysiological or pathological evidence of other disease processes that might explain the signs of LMN and/or UMN degeneration, and (B:2) neuroimaging evidence of other disease processes that might explain the observed clinical and electrophysiological signs.

  * If they were Taiwanese and used traditional Chinese(Mandarin).
  * If they were older than age 20 years.

Exclusion Criteria:

* If they had been diagnosed with frontotemporal dementia, severe depression, or schizophrenia.
* If they cannot see the communication board after correction.
* If they cannot complete the questionnaire with researchers or family members help.

Primary outcomes:
measure: System Usability Scale
timeFrame: 2019.04.01~2019.06.30
Secondary outcomes:
measure: Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R
timeFrame: 2019.04.01~2019.06.30
measure: Taiwanese Depression Questionnaire, TDQ
timeFrame: 2019.04.01~2019.06.30
measure: Caregiver Burden Scale
timeFrame: 2019.04.01~2019.06.30
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: TW
Study officials:
References:
Clinical trial NCT02142634: Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Official title: Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Incomplete Microscopic Colitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.


Eligibility criteria: Inclusion Criteria:

* Histologically established diagnosis of incomplete microscopic colitis (MCi)
* History of chronic non-bloody, watery diarrhoea
* Clinically active disease

Exclusion Criteria:

* Other significant abnormalities in colonoscopy
* Infectious cause of diarrhoea
* Clinical suspicion of drug-induced diarrhoea
* Prior and present MC
* History of bowel resection
* Radiation therapy of the abdominal or pelvic region
* Positive antibody titres for celiac disease
* Untreated active thyroid dysfunction
* Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
* Abnormal hepatic function
* Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
* History of colorectal cancer
* History of cancer (other than colorectal) in the last 5 years
* Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
* Current or intended pregnancy or breast-feeding
* Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial

Primary outcomes:
measure: Rate of clinical remission
timeFrame: 8 weeks
Secondary outcomes:
measure: Rate of clinical remission
timeFrame: 2 weeks
measure: Rate of clinical remission
timeFrame: 6 weeks
measure: Time to remission
timeFrame: 8 weeks
measure: Number of formed/soft/watery stools per week
timeFrame: 8 weeks
measure: Number of days with abdominal pain
timeFrame: 8 weeks
measure: Number of days with urgency
timeFrame: 8 weeks
measure: Rate of histological remission
timeFrame: 8 weeks
measure: Physician's global assessment at final visit
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Centre for Digestive Diseases
city: Linköping
country: Sweden
facility: University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
Study officials:
affiliation: University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
name: Andreas Münch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01369017: Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers
Official title: A Study of the Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Center Reference Endotoxin in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Control Subjects
Keywords: healthy volunteer
endotoxin
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-06-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators want to see if healthy people who are given 2 doses of a medication called anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then exposed to a form of air pollution, called Endotoxin, have less inflammation with the medication. Endotoxin is believed to be one of the causes of asthma attacks.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* age 18-50 years

Exclusion Criteria:

* asthma
* pregnant women
* smokers

Primary outcomes:
measure: blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE
timeFrame: 6 hours after inhalation of CCRE
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: UNC CH SOM
name: Michelle Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02229318: A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Official title: A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizure Disorders
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2014-09-01
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.

Detailed description: The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management.

Primary Hypothesis:

FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet.

Secondary Hypothesis:

FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of condition requiring a Ketogenic diet
2. Currently on a Ketogenic diet
3. Aged 4 - 8 years
4. Routinely taking a complete micronutrient supplement
5. Oral feeding

Exclusion Criteria:

1) Children aged less than 4 years or older than 9 years of age

Primary outcomes:
measure: Acceptability of FruitiVits
timeFrame: Day 8 of trial
Secondary outcomes:
measure: Ease of Preparation of FruitiVits
timeFrame: Day 8 of trial
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia, Division of Neurology
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Christina Bergqvist, M.D
role: PRINCIPAL_INVESTIGATOR
References: