louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00879294: The Effect of Gum Chewing on Postoperative Ileus
Official title: The Effect of Gum Chewing on Postoperative Ileus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perforated Appendicitis
Keywords: Perforated appendicitis
Ruptured appendicitis
Acute appendicitis with perforation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.

Detailed description: After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.

Eligibility criteria: Inclusion Criteria:

* any child who has undergone appendectomy for perforated appendicitis

Exclusion Criteria:

* age less than or equal to 5 years
* unable to chew gum safely
* interval appendectomy

Primary outcomes:
measure: Time to resolution of post-operative ileus.
timeFrame: 1-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Brenner Children's Hospital
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas Pranikoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218894: The Influence of Vision on Balance, Gait and Falls
Official title: The Effect of Cataract Surgery on Gait, Balance and Falls in Older Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Effect
Balance
Gait
Falls
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Midt-Norge
First posted: 2005-09-22
Enrollment: 148
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients (70 years and older) referred to cataract surgery in StOlavs Hospital, Trondheim Norway.

Brief summary: Falls are the most serious and frequent home accident amongst elderly. Most falls occur during walking. Vision is reduced with ageing and visual impairments affect balance. Uncorrected visual deficits and balance problems are reported to be risk factors for falls and fall related fractures. The present project uses a longitudinal design and aims at assessing the impact of cataract surgery on balance and gait as risk factors for falls.

Detailed description: A longitudinal design is used, where subjects referred to the Cataract Unit are tested 1-3 weeks in advance of the surgery, and 4-6 weeks and 12 months after the surgery. Outcome measures are visual function, falls, balance and gait. Secondary outcome is quality of life, fear of falling and daily life functioning

Eligibility criteria: Inclusion Criteria:

* \>70 years of age
* referred to cataract surgery on one or both eyes
* able to walk unassisted at least 10 m

Exclusion Criteria:

* terminal illness
* have undergone orthopedic surgery in the lower limbs the last 12 months
* Have had a stroke last 12 months
* dementia (measured by MMSE \<20

Primary outcomes:
measure: Falls
timeFrame: over one year
measure: Visual function
timeFrame: pre surgery, 6-9 weeks and 1 year post surgery
Secondary outcomes:
measure: Health related Quality of Life
timeFrame: pre surgery, 6-9 weeks and one year after surgery
measure: Gait
timeFrame: pre surgery, 6-9 weeks and one year after surgery
measure: Fear of falling
timeFrame: pre surgery, 6-9 weeks and one year after surgery
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Section of Geriatric Medicine, St. Olavs University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Olav Sletvold, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helbostad JL, Oedegaard M, Lamb SE, Delbaere K, Lord SR, Sletvold O. Change in vision, visual disability, and health after cataract surgery. Optom Vis Sci. 2013 Apr;90(4):392-9. doi: 10.1097/OPX.0b013e3182843f16.
Clinical trial NCT03449394: Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
Official title: Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delusions
Depression
Keywords: Psychosis
Depression
Metacognition
Attribution
Emotions
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 113
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: TREATMENT

Brief summary: Psychological studies have shown that individuals tend to attribute causes of positive and negative events differently. Specifically, individuals hold an internalising or externalising bias of attribution which, in the case of particular patient groups, was found to polarize to the extreme. Such extreme attributional styles have found to have a direct impact on emotions, leading to a waning course of psychiatric disorders. This project aims to further examine the theoretical links between attributions and emotions using a transdiagnostic approach, and the effect of a 4-session process-based intervention on attributional biases.


Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* Clinical diagnosis of non-organic psychosis or major depressive disorder
* Presentation of delusions/a moderate level of depression

Exclusion Criteria:

* Clinical diagnosis of psychotic depression or depression with psychotic features
* Primary diagnosis of substance misuse or learning disability
* Participation of any cognitive/reasoning training program

Primary outcomes:
measure: Attributional style as measured by the Internal, Personal and Situational Attributions Questionnaire (IPSAQ)
timeFrame: 6 months
measure: Psychotic symptomatology as measured by Positive and Negative Syndrome Scale (PANSS)
timeFrame: 6 months
measure: Depressive symptomatology as measured by Beck Depression Inventory - II (BDI-II) and Calgary Depression Scale (CDS)
timeFrame: 6 months
measure: Conviction of beliefs as measured by the Psychotic Symptom Rating Scale (PSYRATS)
timeFrame: 6 months
measure: Belief flexibility as measured by Maudsley Assessment of Delusions Schedule (MADS) and the BADE task
timeFrame: 6 months
measure: State-trait personality as measured by the State-Trait Personality Inventory (STPI)
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive capacity as measured by the Chinese version of the Wechsler Adult Intelligence Scale - III (WAIS-III)
timeFrame: Baseline
measure: Severity of generalized anxiety disorder as measured by Generalised Anxiety Disorder 7 (GAD-7)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT06496594: Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials
Official title: Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials: 12-months Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effect of a 12-month peri-implant protocol with erythritol orultrasonic scaler with peek inserts for dental implants with crowns made by different materials .

Patients will be randomly divided into two groups:

Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS) Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) .

Different subgroups will be defined according to the material of the dental crown of the related implant.

The mechanical debridement appointments will be carried out at the baseline, after 6 months, and after 12 months, after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Control Record.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70
* Presence of at least one dental implant
* Good compliance

Exclusion Criteria:

* Patients with cardiac stimulators
* Patients with neurological disorders
* Patients with psychological disorders
* Pregnant women

Primary outcomes:
measure: Change in Probing Depth (PD)
timeFrame: Baseline (T0), 6 months (T1), 12 months (T2)
measure: Change in Bleeding on Probing (BoP)
timeFrame: Baseline (T0), 6 months (T1), 12 months (T2)
measure: Change in Plaque Control Record
timeFrame: Baseline (T0), 6 months (T1), 12 months (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02129894: The Use of Abdominal Binders in Patients Undergoing Cesarean Sections
Official title: The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cesarean Section Post Operative Management
Keywords: cesarean section
postoperative pain
pregnancy
abdominal binder
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To see if the use of Abdominal Binders improves patients out comes after cesarean delivery

Detailed description: Inclusion: All patients admitted to labor and delivery

Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.

Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.

Eligibility criteria: Inclusion Criteria:

Women undergoing cesarean section for any indication

Exclusion Criteria:

* unable to give consent

Primary outcomes:
measure: Pain measurement
timeFrame: up to post operateive day 2
measure: Patient Distress score
timeFrame: up to post operateive day 2
Secondary outcomes:
measure: hemoglobin and hematocrit
timeFrame: post operative day 1 and 2
measure: Pain medication usage
timeFrame: post operative day 1 and 2
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St Luke's University Hospital
state: Pennsylvania
Study officials:
References:
citation: Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
citation: Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.
Clinical trial NCT03548194: A Study of BNC210 in Elderly Patients With Agitation
Official title: A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Agitation in the Elderly
Lead sponsor: Bionomics Limited
Sponsor class: INDUSTRY
First posted: 2018-06-07
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II randomised, double-blind, placebo-controlled study assessing the effects of BNC210 on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS). Safety and tolerability of BNC210 will also be assessed.

The secondary objectives of the study include evaluation of the effects of BNC210 on global function in patients with agitation as assessed by the Clinical Global Impression Scale (CGI-S/I).

Participants will receive 5 days of blinded treatment followed by 2 days of follow up.


Eligibility criteria: Key Inclusion Criteria:

* Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician
* Determined to have agitation requiring intervention in addition to standard of care behavioural management, as assessed by the Investigator or delegate, after at least 24 hours following admission to hospital.

Key Exclusion Criteria:

* Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).
* Diagnosed with Severe Parkinson's Disease.
* Premorbid psychotic illness as assessed by the Investigator.
* Evidence of severe organ dysfunction
* Confirmed metastatic malignancy.

Primary outcomes:
measure: Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
timeFrame: 5 days
Secondary outcomes:
measure: Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)
timeFrame: 5 days
measure: Proportion of participants reaching the "Non-Agitated" state
timeFrame: 5 days
measure: Time to first reach a "Non-Agitated" state.
timeFrame: 5 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Modbury Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Northern Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Western Health
state: Victoria
Study officials:
References:
Clinical trial NCT02098694: Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
Official title: Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylarthritis
Spondylitis, Ankylosing
Spondylarthropathies
Sacroiliitis
Arthritis, Psoriatic
Keywords: Physiotherapy
Outpatient clinic
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Møre og Romsdal HF
First posted: 2014-03-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether patients with spondyloarthritis are more satisfied with a physiotherapy-led outpatient clinic than usual care and whether there is a difference between patients in a physiotherapy-led outpatient clinic and those in usual care regarding disease activity, function and mobility.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis spondyloarthritis, ankylosing spondylitis, spondylarthropathy, juvenile ankylosing spondylitis, psoriatic arthritis with affection of the spine
* age between 18 and 45 (born 1969 - 1996)

Exclusion Criteria:

* also diagnosed with potentially functionally impairing neuromuscular, neurological or muscular disorders
* insufficient Norwegian language skills
* cognitive impairment
* no sign of inflammation or bone erosions in the sacroiliac joints or in the spine on imaging

Primary outcomes:
measure: Leeds Patient Satisfaction Questionnaire (LSQ)
timeFrame: 8 months
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: 8 months
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 8 months
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 8 months
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Department of Rheumatology, Ålesund hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ann-Katrin Stensdotter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holoyen PK, Stensdotter AK. Patients with spondyloarthritis are equally satisfied with follow-up by physiotherapist and rheumatologist. Musculoskeletal Care. 2018 Sep;16(3):388-397. doi: 10.1002/msc.1241. Epub 2018 Mar 24.
Clinical trial NCT04802694: The Effects of The Products Used In Nazogastric Tube Fixation
Official title: Comparison of The Effects of The Products Used In Nazogastric Tube Fixation on Skin Integrity In Babies: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Injury
Keywords: infant
skin
adhesives
fixation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study was planned to compare the effect of products, used in the fixation of nasogastric tube, on skin integrity of 4-6 weeks infants hospitalized at neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to protect skin integrity than hydrocolloid barrier tape."

Detailed description: The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods protecting skin deficiencies using adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of October 2020-2021. Power analysis was performed through G\*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a pilot study was carried out with 15 participants from each of the groups and the effect size was calculated as d=0.672 regarding the assessment of skin condition scores and 108 participants in total should be included in the study as 36 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant desciption form" and "Neonatal Skin Condition Score Scale" is used. The scale is filled by two independent observer via double-blind method.

Eligibility criteria: Inclusion Criteria:

* All the 4-6 weeks infants including interventional process and without any skin diseases

Exclusion Criteria:

* The infants receiving treatment without any interventional process
* Those having a skin disease
* Those infants having PICC and SVK catheters and do not meet the required criteria

Primary outcomes:
measure: Water-based barrier tape
timeFrame: 24 hours
measure: Hydrocolloid barrier tape
timeFrame: 24 hours
measure: Adhesive tape
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University Women and Children's Hospital
Study officials:
References:
citation: Lund CH, Osborne JW. Validity and reliability of the neonatal skin condition score. J Obstet Gynecol Neonatal Nurs. 2004 May-Jun;33(3):320-7. doi: 10.1177/0884217504265174.