louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00082524: Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
Official title: A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aspergillosis
Candidiasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).


Eligibility criteria: * Children, 3 months through 17 years of age,
* with esophageal candidiasis or
* invasive candidiasis or
* children requiring salvage treatment of invasive aspergillosis.

Primary outcomes:
measure: The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
Secondary outcomes:
measure: The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
measure: The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Zaoutis TE, Jafri HS, Huang LM, Locatelli F, Barzilai A, Ebell W, Steinbach WJ, Bradley J, Lieberman JM, Hsiao CC, Seibel N, Laws HJ, Gamba M, Petrecz M, Taylor AF, Strohmaier KM, Chow JW, Kartsonis NA, Ngai AL. A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients. Pediatrics. 2009 Mar;123(3):877-84. doi: 10.1542/peds.2008-1158.
Clinical trial NCT06378424: The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization
Official title: The Effectiveness of Local Dry Cold, Hot and Vibration Applications During Peripheral Intravenous Catheterization Placement in the Emergency Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Emergency Unit
Diarrhea
Nausea
Vomiting
Keywords: Hot application
cold application
peripheral intravenous catheterization
venous dilation
pain
vibration
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 120
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: SUPPORTIVE_CARE

Brief summary: Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.

Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale.


Eligibility criteria: Inclusion Criteria:

* Being in accordance with time and place
* Being aged between 18 and 65 years
* Being able to evaluate the visual analog scale correctly
* Participating voluntarily in the research.

Exclusion Criteria:

* Not participating voluntarily in the research
* Not fitting the inclusion criteria of the research
* Having a vision or hearing problem
* Having a mastectomy
* Having any illness which could affect pain perception, such as sensory-motor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy
* Having an allergy to heat and cold application
* Having phlebitis, scar tissue, dermatitis, an incision or findings of infection at the place where the intervention was to be performed
* Having taken an analgesic (within the previous six hours) or an anesthetic agent before the peripheral intravenous catheterization procedure

Primary outcomes:
measure: pain intensity in mm
timeFrame: 6 months
measure: venous dilation in score
timeFrame: 6 months
measure: procedure duration in sec
timeFrame: 6 months
Secondary outcomes:
measure: weight
timeFrame: 6 months
measure: height
timeFrame: 6 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University Hospital
state: Nilüfer
Study officials:
References:
Clinical trial NCT02884024: Effects of Weight on Inflammation and Colon Cancer Risk
Official title: Study on the Effects of Weight on Inflammation and Colon Cancer Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: obesity
inflammation
cancer risk
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
First posted: 2016-08-30
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 43 generally healthy adults of both genders undergoing routine screening colonoscopy at Tufts Medical Center

Brief summary: An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals

Detailed description: An observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. They had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.

Eligibility criteria: Inclusion Criteria:

1. Caucasian
2. undergoing clinically-indicated screening colonoscopy
3. BMI\< or = 25, or 30+

Exclusion Criteria:

1. past history of cancer (except non-melanoma skin cancer)
2. a polyposis syndrome
3. any current or chronic inflammatory disease or infection
4. incapable of providing valid informed consent

Primary outcomes:
measure: colonic concentration of Tumor Necrosis Factor-alpha
timeFrame: time zero: at baseline
measure: colonic concentration of Interleukin-6
timeFrame: time zero: at baseline
measure: colonic concentration of Interleukin-1 beta
timeFrame: time zero: at baseline
measure: colonic concentration of Interferon-gamma
timeFrame: time zero: at baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02994524: Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Transsphincteric Perianal Fistula
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 25
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: .Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .

Detailed description: Lay open is the classic surgical management for Peri Anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,Many surgical techniques have been described for sphincter preservation ,But unfortunately associated high recurrence rate.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .The operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.

Eligibility criteria: Inclusion Criteria:

* High arching transsphincteric fistula
* Transsphincteric fistula with high internal opening
* Transsphincteric fistula with short anal canal.
* Horseshoe perianal fistula fulfilling above criteria.

Exclusion Criteria:

* Transsphincteric fistula.
* Low perianal fistula.

Primary outcomes:
measure: Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01912924: A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery
Official title: A Prospective Single Centre Open Label Trial to Assess the Effectiveness of the Use of Spinal Cord Stimulation in Subjects With Chronic Knee Pain "Failed Knee Surgery"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain from failed knee surgery
Lead sponsor: Coastal Orthopedics & Sports Medicine
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2013-07-31
Enrollment: 0
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: A study for patients who have chronic postoperative pain who had knee replacement surgery. If qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain will be administered. This study will evaluate effectiveness of pain control. Subjects will be followed for one year post implantation.

Detailed description: Male and Female over the age of 18 who have had a total knee replacement at least nine months ago. Continue with unilateral knee pain equal to or greater than 4 on a 1 to 10 scale. Subjects will receive a trial placement of spinal cord stimulator for 5 to 10 days. if trial is successful subjects will proceed to permanent placement of stimulator for the treatment of the knee pain. subjects will then be followed post implant to assess the effectiveness of the stimulator for the pain.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* total knee replacement at least nine months prior to enrollment
* unilateral knee pain at least 4 or more on a 1-10 visual analog scale
* failed other conservative treatments -

Exclusion Criteria:

* life expectancy of at least 6 months
* significant disease including Complex Regional Pain Syndrome,ipsilateral radiculopathy
* presence of pacemaker/vns or other Spinal Cord Stimulator
* previous lumbar surgery
* active infection
* unable to hold anticoagulants

Primary outcomes:
measure: Pain Visual Analog Scale
timeFrame: one year
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: one year
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Coastal Orthopedics & Sports Medicine
state: Florida
Study officials:
affiliation: Coastal Orthopedics & Sports Medicine
name: Gennady Gekht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01685424: Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)
Official title: Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Gout
Arthritis
Keywords: Etoricoxib
ARCOXIA
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Gout
Arthritis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-09-14
Enrollment: 79189
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.

Brief summary: This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).


Eligibility criteria: Inclusion Criteria:

* All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.

Exclusion Criteria:

* Not registered in a GPRD-contributing practice that had continuously

collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015.

* Never registered as a permanent patient of a General Practitioner in the practice
* Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
* Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD

Primary outcomes:
measure: Dose of Initial Etoricoxib Prescription
timeFrame: At first prescription (during a time period up to 13.75 years)
measure: Duration of Initial Etoricoxib Prescription
timeFrame: At first prescription (during a time period up to 13.75 years)
measure: Participant's Baseline Characteristics (Demographics and Medical)
timeFrame: At first prescription (during a time period up to 13.75 years)
measure: Incidence of Adverse Events of Special Interest Among Etoricoxib Users
timeFrame: During a time period up to 13.75 years
Secondary outcomes:
measure: "Off-label" use of Etoricoxib
timeFrame: At first prescription (during a time period up to 13.75 years)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03513224: The eDosette Pilot Study
Official title: The Use of an Electronic Medication Administration-monitoring Device to Improve Medication Adherence and Reduce Medication Regimen Complexity in Community Dwelling Seniors: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 57
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medication non-adherence can lead to serious health issues for older adults. This study is a four week study in older adults using a new device, the eDosette, which dispenses and records how one takes their medications, and subsequently makes this information available to the primary care team by the internet. This study aims to show that the eDosette can report how well a group of older adults living independently in the community are taking their medications (e.g. "medication adherence"). This study hopes to show that the eDosette intervention could play a role in medication adherence by improving conversations between older adults and primary care.


Eligibility criteria: Inclusion Criteria:

* age 65 and over
* taking five or more medications (including supplements)
* using or willing to use a blister pack or dosette
* currently managing their medications independently
* living independently
* English speaking

Exclusion Criteria:

* a documented diagnosis of mild cognitive impairment or dementia
* living in any form of assisted living facility
* currently palliative
* currently deemed medically unstable by their primary care team

Primary outcomes:
measure: Four-week medication adherence rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Thematic content of pharmacist-participant discussion during the study
timeFrame: 4 weeks
measure: Frequency of medication changes noted
timeFrame: 4 weeks
measure: Change in MRCI score
timeFrame: 4 weeks
measure: Participant feedback
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Siu HY, Mangin D, Howard M, Price D, Chan D. Developing and testing an electronic medication administration monitoring device for community dwelling seniors: a feasibility study. Pilot Feasibility Stud. 2017 Feb 1;3:5. doi: 10.1186/s40814-016-0118-3. eCollection 2017.
Clinical trial NCT01311024: Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
Official title: Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Keywords: Children
Pneumococcal Vaccines
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: GlaxoSmithKline
First posted: 2011-03-09
Enrollment: 2341
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-PCV-vaccinated 3 to 7 year-old siblings living in the same household with a younger child vaccinated in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Brief summary: The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

Detailed description: The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.

Eligibility criteria: Inclusion Criteria:

* age 3 to 7 years
* younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
* at least one parent with fluent Finnish
* informed consent from one parent

Exclusion Criteria:

* commercial PCV vaccination administered
* study-related PCV vaccination administered (open or blind)
* history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Primary outcomes:
measure: Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules
timeFrame: one sampling at 3 to 7 years of age
Secondary outcomes:
measure: Carriage Due to Any Pneumococcal Serotype
timeFrame: one sampling at 3 to 7 years of age
measure: Carriage Due to Haemophilus Influenzae
timeFrame: one sampling at 3 to 7 years of age
measure: Invasive Pneumococcal Disease
timeFrame: Up to 8 years
measure: Hospital-diagnosed Pneumonia
timeFrame: Up to 8 years
measure: Tympanostomy Tube Surgery
timeFrame: Up to 8 years
measure: Outpatient Antibiotic Treatment
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: National Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Arto A Palmu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04744324: Self-supporting Care Model in Home Environment for Patients With Stroke
Official title: Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Activities of Daily Living
Keywords: Stroke
Self-supporting Care Model
Home Care Services
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to administer intervention based on self-supporting care model in home environment and to explore the effects of this intervention on stroke patients' activities of daily living, movement, cognition, nutritional status, and quality of life.

Detailed description: Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 8 measures: Barthel Index-based Supplementary Scales, Canadian Occupational Performance Measure, Fugl-Meyer Assessment, Balance Computerized Adaptive Testing, Mini Mental State Examination-2nd edition, Mini Nutritional Assessment, Stroke Impact Scale, and Stroke Self-Efficacy Questionnaire.

Eligibility criteria: Inclusion Criteria:

* age \> 20 years
* Diagnosis of stroke
* The modified Rankin Scale : 2\~4
* Keep sitting for half an hour by himself/herself
* Follow instructions
* Willing to sign the subject's consent

Exclusion Criteria:

* Diagnosis of dementia
* History of orthopedic diseases or peripheral nerve injury
* readmission because of stroke

Primary outcomes:
measure: Barthel Index -based Supplementary Scales
timeFrame: Baseline to 4 weeks
measure: Canadian Occupational Performance Measure
timeFrame: Baseline to 4 weeks
measure: Fugl-Meyer Assessment
timeFrame: Baseline to 4 weeks
measure: Balance computerized adaptive testing
timeFrame: Baseline to 4 weeks
measure: Mini Mental State Examination-2nd edition
timeFrame: Baseline to 4 weeks
measure: Mini Nutritional Assessment
timeFrame: Baseline to 4 weeks
measure: Stroke Impact Scale
timeFrame: Baseline to 4 weeks
measure: Stroke Self-Efficacy Questionnaire
timeFrame: Baseline to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
state: Shihlin District
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: En-Chi Chiu, PhD
role: STUDY_DIRECTOR
References: