louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00961610: Internet-based Support in Cancer Rehabilitation
Official title: Internet-based Support in the Rehabilitation of Danish Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: internet support
cancer
rehabilitation
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: IMK Almene Fond
First posted: 2009-08-19
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 66 scheduled rehabilitation course weeks were screened for eligibility between 19 April 2004 and 31 December 2005 from the Rehabilitation Centre Dallund in Denmark. All 58 eligible courses including 921 individuals were enrolled and randomized as 27 case weeks (n = 416 persons) and 31 control weeks (n = 505 persons). Baseline assessments were obtained from 799 individuals. Data from 10 individuals (5 from each treatment group) were subsequently excluded, as they did not attend a rehabilitation course week as planned, leaving final study population of 794 individuals analyzed by 'intention-to-treat' (case: n = 361/794; control: n = 433/794). Participants were followed up for 12 months in accordance with their dates of attendance of the rehabilitation course from 19 April 2004 till 31 December 2006.

Brief summary: This 2-arm randomized trial assessed the incremental effect of providing a lecture on Internet use followed by participation in an Internet-based peer support group following a week-long rehabilitation program, over and above any possible general effect of participation in the rehabilitation program.

Primary outcome measures are adjustment to cancer and mood disturbance.


Eligibility criteria: Inclusion Criteria:

* Cancer survivors who were randomized for or self-selected to a rehabilitation course at the Dallund Rehabilitation Centre were included in the study.

Exclusion Criteria:

* Rehabilitation course weeks in which cancer survivors over 50 years of age were targeted specifically were excluded.

Primary outcomes:
measure: Adjustment to cancer measured by the Mini-MAC scale Mood disturbance measured by POMS-SF scale
Secondary outcomes:
measure: Self-rated global health
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Psychsocial Cancer Research
Study officials:
affiliation: Department of Psychosocial Cancer Research
name: Christoffer Johansen, MD, PhD, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122510: Transverse Abdominal Block for Analgesia in Casarean Section
Official title: The Value of Preemptive Dexmedetomidine Transversus Abdominis Plane (TAP) Block in Patients Undergoing Elective Cesarean Section Under General Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia Disorder
Keywords: Analgesia, casarean section, TAP block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators will compare the analgesic effect of bupivacaine and bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP block, on the patients for whom the operation will be performed under general anesthesia.

Detailed description: The investigators will study 60 ASA \[American Society of Anesthesiologist\] physical status I and ІІ patients undergoing elective cesarean delivery at tanta University Hospital, in a prospective, randomized, comparative, clinical trial.

Patients will be randomly allocated to two equal groups (n = 30) using closed envelopes labeled 1,and 2 reflecting group 1and 2 respectively.

The drugs are prepared by the anesthesiologist who is not involved in the study or data collection.

Group I: (n=30) will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2.

Group II: (n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G2.

Eligibility criteria: Inclusion Criteria:

1. We will study 60 ASA \[American Society of Anesthesiologist\] physical status I and ІІ patients undergoing elective cesarean delivery
2. Age between 21-40 years old.

Exclusion Criteria:

1. Refusal of participation in the study
2. Patients who have infection or tumor at the site of puncture for local anesthetic injection.
3. Patients who have coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs.
4. Patients known to have allergy or sensitivity to dexmetomedine, and/or bupivacaine
5. Severe hepatic and/or renal insufficiency
6. Morbid obesity (body mass index (BMI) \>35)
7. Psychological disease

Primary outcomes:
measure: hemodynamic changes
timeFrame: 2 hours
Secondary outcomes:
measure: Analgesic requirements
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Algharbiya
Study officials:
affiliation: Assistant professor
name: Ayman A Yousef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Ayman A Yousef, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02703610: Randomized Trial of Two Analgesics in Elderly ED Patients
Official title: Randomized Trial of Two Analgesics in Elderly ED Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: Pain
Elderly
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.

Detailed description: To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows:

1. Oxycodone/acetaminophen (5/325)
2. Ibuprofen/acetaminophen (400/500)

Eligibility criteria: Inclusion Criteria:

* Complaint of acute pain of \< 7 days duration
* ED attending plans to discharge patient home with an oral analgesic

Exclusion Criteria:

* Inability to confirm reliable means of phone followup.
* Past use of methadone
* Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
* History of an adverse reaction to any of the study medications
* Ibuprofen or acetaminophen or opioids taken in past 4 hours
* History of peptic ulcer disease
* Report of any prior use of recreational narcotics
* Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease

Primary outcomes:
measure: Between group difference in change in NRS pain scores
timeFrame: 24 hours
Secondary outcomes:
measure: Between group difference in change in NRS pain scores at first followup contact
timeFrame: 24-72 hours
measure: Between group difference in change in NRS pain scores
timeFrame: 48 hours and 72 hours
measure: Between group difference in side effects
timeFrame: 24 hours, 48 hours and 72 hours
measure: Change in NRS pre and 2 hours post most recent dose of pain medication taken
timeFrame: 24 hours
measure: Between group difference in Likert pain scores
timeFrame: 24, 48, and 72 hours
measure: Satisfaction
timeFrame: 24, 48, and 72 hours
measure: Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
timeFrame: 24-72 hours
measure: Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
timeFrame: 24-72 hours
measure: Want same medication again
timeFrame: 24-72 hours
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT05928910: Virtual Reality (VR) During Peripheral Nerve Evaluation (PNE) Procedure
Official title: Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE).


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction

Exclusion Criteria:

* Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study
* Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, etc., which could compromise the physical function of the headset

Primary outcomes:
measure: Change In Pain as Measured by Numeric Pain Scale
timeFrame: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
measure: Change in Anxiety as Measured by State Trait Anxiety Inventory
timeFrame: Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
Secondary outcomes:
measure: Satisfaction with Procedure as measured by Likert Scale
timeFrame: up to one hour post-procedure
measure: Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale
timeFrame: up to one hour post-procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Raveen Syan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06487910: Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
Official title: Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Hypertrophic Scar
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-07-05
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: OTHER

Brief summary: This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.

To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).


Eligibility criteria: Inclusion Criteria:

* Adult Patients aged \> 18 years old
* Patient with at least one hypertrophic burn scar in the process of healing localized on a skin area that can benefit from a compression garment and requiring the use of an ORDP
* Patient able to give informed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patients under guardianship, curatorship or safeguard of justice
* Pregnant or breast-feeding women

Primary outcomes:
measure: Sucess of the manufacture process of the orthosis
timeFrame: 2 to 3 hours after inclusion
Secondary outcomes:
measure: Time of conception
timeFrame: 2 to 3 hours after inclusion
measure: Total time to design the orthosis
timeFrame: 2 to 3 hours after inclusion
measure: Total cost of the orthosis fabrication
timeFrame: 2 to 3 hours after inclusion
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital Félix Maréchal
Study officials:
affiliation: CHR Metz Thionville Hopital Félix Maréchal
name: Loic BANASZAK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205710: Adaptive Cognitive Training in Healthy Older Adults
Official title: Adaptive Cognitive Training in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Mild to Moderate Dementia
Alzheimer's Disease
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2014-07-31
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate cognitive function in older adults and individuals with dementia. In recent years, such training has become particularly appealing in the clinical context, with many paradigms aimed specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For example, uncertainty persists regarding factors that influence observed improvements as well as the conditions that would maximize transfer and sustainability of training effects. The objective of this study is to evaluate factors that may maximize the benefits of computerized cognitive training in older adults.

Detailed description: The study involves 25 sessions of an adaptive cognitive training program, completed over 5 weeks. Pre and post training assessments will evaluate any near and far transfer effects of training.

Eligibility criteria: Inclusion Criteria:

* English as the maternal or primary spoken language.
* Good self-reported health (i.e., no cerebro-, or cardio-vascular disease or neurological disease).
* Normal or corrected-to-normal vision and hearing.

Exclusion Criteria:

* Poor hearing or vision
* Inadequate understanding of the English language

Primary outcomes:
measure: Change in ratings on cognitive training survey
timeFrame: Baseline, week 5
measure: Change in neural activity
timeFrame: Baseline, week 5
measure: Change in performance on neuropsychological tests
timeFrame: Baseline, week 5
Secondary outcomes:
measure: Change in ratings of psychological wellbeing
timeFrame: Baseline, week 5
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Patrick Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Sheida Rabipour, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01765010: The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels
Official title: Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Vitamin D
Serum sclerostin
Serum dickkopf1
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 88
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer older than 20 years

Exclusion Criteria:

* Subjects with bone and mineral metabolism disorders
* Subjects with kidney or liver diseases
* Subjects with uncorrectable hypercalcemia or hypocalcemia
* Subjects with chronic gastrointestinal disorders or malabsorption
* Subjects taking medication related to bone loss

Primary outcomes:
measure: Change of serum sclerostin level
timeFrame: 8 weeks later
measure: Change of serum Dickkopf1 level
timeFrame: 8 weeks later
Secondary outcomes:
measure: Change of serum c-telopeptide level
timeFrame: 8 weeks later
measure: Change of serum bone-specific alkaline phosphatase level
timeFrame: 8 weeks later
measure: Change of serum calcium level
timeFrame: 8 weeks later
measure: Change of serum parathyroid hormone level
timeFrame: 8 weeks later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Medical School
Study officials:
affiliation: Seoul National University Medical School
name: Chan Soo Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749410: A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Migraine, Headaches
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as Treatment for Chronic Migraine.

Brief summary: This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.


Eligibility criteria: Inclusion Criteria:

* 15 or more headache days over a 30 day period
* A minimum of 7 treatment cycles with onabotulinumtoxinA

Exclusion Criteria:

* Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

Primary outcomes:
measure: Change From Baseline in the Number of Headache Days
timeFrame: Treatment Cycle 7 (approximately 1.5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01549210: Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life
Official title: Multicentre Prospective Observational Study for Identification of Determinants of Disability and Quality of Life in Patients With Gout.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gout
Keywords: gout
gouty arthritis
Lead sponsor: Italian Society for Rheumatology
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referring to rheumatologic clinics

Brief summary: The study aims to identify which characteristics are associated with disability and poor quality of life in patients suffering from gout. This is a multicentre prospective observational study carried out in a cohort of Italian patients with gout. Subjects are randomly selected from a list of patients referred to each participant rheumatology clinic in the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months; data are retrieved about sociodemographic variables, life-styles, history of gout, comorbidities and patterns of treatment. At each visit patients complete questionnaires assessing disability and health-related quality of life. Preplanned analyses will be performed to investigate predictors of disability and poor quality of life in these patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gout
* Must be able to understand questionnaires

Exclusion Criteria:

* Diagnosis not validated by rheumatologist
* Not able to sign informed consent

Primary outcomes:
measure: Functional disability
timeFrame: 1 year
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 1 year
Other outcomes:
measure: Short Form-36 Mental Summary Scale (SF-36 MCS)
timeFrame: 1 year
measure: Serum uric acid levels
timeFrame: 6-12 months
Locations:
city: Pavia
country: Italy
facility: Dept of Rheumatology - IRCCS San Matteo Foundation
Study officials:
affiliation: Epidemiology Unit - Italian Society for Rheumatology
name: Carlo A Scirè, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: