louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01448980: Efficacy of Massage in Stroke Spasticity
Official title: The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke; Sequelae
Keywords: massage
stroke spasticity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 396
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is one of the common diseases in the elderly. It is the third ranking cause of death and affects health care system in our country. One of the most important consequences of stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive reflex to stimuli. It can cause contracture, limit self care function, transfer or ambulation. Most of stroke patients have to depend on their relatives or families.

Detailed description: Thai traditional massage is one of the popular alternative medicine in Thailand. Lots of stroke patients who suffered from spasticity sought treatment. To the investigators knowledge, there is no study concerning efficacy of massage in decreasing spasticity for stroke patients.

Eligibility criteria: Inclusion Criteria:

* Stroke with onset of \>=6 months
* Age \>=50 years
* Spasticity grade of knee flexor or elbow flexor was 2-3 classified by Modified Ashworth scale (MAS)
* Ability to follow command and communicable

Exclusion Criteria:

* Having contraindications for massage including fever \> 38 degree, uncontrolled blood pressure, bleeding tendency, on anticoagulant drug, having ulcer or healing fracture of limbs, contamination skin disease, severe osteoporosis
* Serious contact diseases, for example AIDS, TB
* History of malignancy
* Fixed joint contracture at elbow or knee of paralyzed limb
* History of botulinum toxin injection or Phenol/Alcohol nerve block within 3 months
* Previous history of TTM
* Severe dementia or uncontrolled psychiatric problems

Primary outcomes:
measure: Modified Ashworth scale (MAS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Modified Barthel index (BI)
timeFrame: 6 weeks
measure: Hospital anxiety depression score (HADS)
timeFrame: 6 weeks
measure: Thai Pictorial Quality of Life questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
name: Vilai Kuptniratsaikul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thanakiatpinyo T, Suwannatrai S, Suwannatrai U, Khumkaew P, Wiwattamongkol D, Vannabhum M, Pianmanakit S, Kuptniratsaikul V. The efficacy of traditional Thai massage in decreasing spasticity in elderly stroke patients. Clin Interv Aging. 2014 Aug 11;9:1311-9. doi: 10.2147/CIA.S66416. eCollection 2014.
Clinical trial NCT04377880: Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.
Official title: Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: Bone
Osteoporosis
Osteoblast
Adipocyte
Cellular models
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Universite du Littoral Cote d'Opale
First posted: 2020-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a surgical indication for a prosthetic hip joint at the Boulogne-sur-Mer hospital.

Brief summary: The recent studies suggest that secretions from medullary adipocytes are involved in the mechanisms of bone loss in osteoporosis (OP) through their actions on neighbouring osteoforming cells, the osteoblasts. The objective of the research is the development of new cellular models representing the aging skeleton to confirm this hypothesis. To this end, osteoblasts will be isolated from human bone fragments coming from femoral heads discarded during total hip replacement surgery. The osteoblastic response to secreted factors released from medullary adipocytes of commercial origin will be analysed using conditioned media incubations. This phenotypic response will be quantified for each subject through the analysis of gene expression levels. Inter-subject phenotype variations will be related to bone density and microarchitecture data obtained by X-ray microtomography. This will assess the existence of a correlation between the osteoblast response to adipocyte secretions and the degree of osteoporosis of the subject from whom the cells are derived.


Eligibility criteria: Inclusion Criteria:

* Adult subject
* Surgical indication for hip prosthesis implantation
* Affiliation to a social insurance regime

Exclusion Criteria:

* Rejection of participation
* Diagnosed bone diseases other than osteoarthritis or osteoporosis
* Cancer
* Pregnant Women
* Subject under guardianship or trusteeship
* Subject unable to understand the study.

Primary outcomes:
measure: the level of gene expression of adipocyte markers such as PPARG and leptin
timeFrame: Baseline
Secondary outcomes:
measure: Inter-subject phenotype variations by X-ray microtomography
timeFrame: Baseline
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre hospitalier
Study officials:
affiliation: University Hospital, Lille
name: Eric FODZO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004480: Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Keywords: dermatologic disorders
hyperhidrosis
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis.

Detailed description: PROTOCOL OUTLINE:

Patients receive injections of botulinum toxin in the clinical trial for 6 months. Patients undergo an iodine starch test and a sympathetic skin response test to assess the efficacy of the drug. Patients also complete questionnaires to evaluate the amount of sweating.

Eligibility criteria: * Diagnosis of hyperhidrosis
* Excessive sweating in the hands, feet, armpits, forehead, or body

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Horacio Kaufmann
role: STUDY_CHAIR
References:
Clinical trial NCT00905580: Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Official title: Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: thyroidectomy
pain, postoperative
pregabalin
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age ≥ 20 and ≤ 65 years
3. Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
2. Body mass index ≥ 40 kg/m2
3. History of seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. Insulin-dependent diabetes mellitus
7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)

Primary outcomes:
measure: Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
timeFrame: 1, 6, 24 & 48 hours
measure: The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
timeFrame: 1, 6, 24 & 48 hours
measure: Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
timeFrame: 1, 6, 24 & 48 hours
Secondary outcomes:
measure: Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Kim SY, Jeong JJ, Chung WY, Kim HJ, Nam KH, Shim YH. Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial. Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8.
Clinical trial NCT04206280: Use of Pedometer Following Radical Prostatectomy
Official title: Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Laparoscopic Robot Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Ambulation Difficulty
Keywords: radical prostatectomy
pedometer
return of bowel function
post-operative narcotic use
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
First posted: 2019-12-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a study to evaluate whether use of a pedometer following radical prostatectomy decreases post-operative narcotic use and time to return of bowel function.

Detailed description: This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical prostatectomy on return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 14. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until initial post-operative visit.

Eligibility criteria: Inclusion Criteria:

This study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at Virginia Mason Medical Center.

Exclusion Criteria:

* Long-term opioid use, defined by CDC as use of opioids on most days for \>3 months
* History of inflammatory bowel disease
* Prior abdominopelvic radiation
* Travel to Europe during study period
* Concurrent surgery during radical prostatectomy
* Inability to ambulate
* Gastroparesis or other baseline bowel dysmotility issues
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Post operative narcotic use
timeFrame: 7-14 days
Secondary outcomes:
measure: Rate of return of bowel function
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: John Corman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995980: Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
Official title: Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer screening
dense breasts
dual-energy contrast-enhanced digital mammography
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 128
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.

Detailed description: This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. At least 19 years old
3. Glomerular filtration rate\> 60
4. Heterogeneously or extremely dense breasts (BI-RADS category c or d).

Exclusion Criteria:

1. History of iodinated contrast allergy
2. Pregnant or lactating as determined by routine standard practice
3. Personal history of breast cancer
4. History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
5. History of prior breast reduction mammoplasty surgery
6. History of prior breast augmentation surgery
7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Primary outcomes:
measure: Percent Accuracy of Contrast Mammography
timeFrame: 1 year
measure: Number of Participants With Cancer Detected
timeFrame: 1 year
Secondary outcomes:
measure: Number of Call Backs With Contrast Mammography
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Heidi R Umphrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01690780: Oral Morphine Versus Ibuprofen
Official title: Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Fractures
Analgesia Post Fracture
Keywords: fracture
pediatric
oral morphine
ibuprofen
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 183
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.


Eligibility criteria: Exclusion Criteria:

* patients with known hypersensitivity to either ibuprofen or morphine
* chronic users of NSAIDS or opioids
* fractures requiring operative management
* associated injuries requiring analgesia
* poor English fluency
* pregnancy

Inclusion Criteria:

* All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Primary outcomes:
measure: Faces Pain scale - revised
timeFrame: 30 minutes post intervention compared to baseline
Secondary outcomes:
measure: Acetaminophen doses
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Naveen Poonai, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
Clinical trial NCT02869880: Trial of Enhanced Pre-Consent Discussion
Official title: Trial of Enhanced Pre-Consent Discussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Crohn's Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: ImproveCareNow (ICN)
name: University of North Carolina, Chapel Hill
First posted: 2016-08-17
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients \> 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.


Eligibility criteria: Inclusion Criteria:

* Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
* Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Knowledge Related to Trial Participation
timeFrame: prior to consent
Secondary outcomes:
measure: Rate of enrollment
timeFrame: at consent
measure: Support subscale of decision conflict scale
timeFrame: prior to consent
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ellen Lipstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03712280: MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Official title: A Randomized, Open-Label, Phase 2a Comparator Study to Assess the Pharmacodynamics, Safety and Pharmacokinetics of Oral Administration MNK6106 (L-Ornithine Phenylacetate) Versus Rifaximin in Subjects With Hepatic Cirrhosis and a History of Prior Episodes of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatic Cirrhosis
Hepatic Encephalopathy (HE)
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 50
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 main reason for this study is to see how the study drug interacts with the body.

It will compare different doses of the study drug with a drug already in use.

Participants will be adults with liver disease that has affected the brain in the past.


Eligibility criteria: Key Inclusion Criteria:

A potential participant may only be included if (at screening), he/she:

1. Understands the study and has signed informed consent
2. Is an adult, not pregnant or lactating
3. Has cirrhosis of the liver
4. Has had 1 instance of HE within 12 months
5. Has hyperammonaemia defined as ≥37 μmol/L at screening

Key Exclusion Criteria:

A potential participant will be excluded if (at screening), he/she:

1. Has contraindicated allergies
2. Expects liver transplant within 1 month
3. Has had a liver shunt within the last 3 months
4. Has inadequate kidney, gastrointestinal, or cardiac function
5. Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:

   1. the safety and well-being of the participant or potential offspring
   2. the safety of study staff
   3. the analysis of results

Primary outcomes:
measure: Ammonia Plasma Levels at Baseline and Day 5
timeFrame: Baseline, Day 5
Secondary outcomes:
measure: Number of Participants With Adverse Events by the End of the Trial
timeFrame: within 15 days
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials
state: California
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion (Research Foundation)
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: