louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06124352: Correlation Between Clinical Measurement Scales for Gross Motor Function
Official title: Correlation Between Clinical Measurement Scales for Gross Motor Function in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In this single-group cross-sectional study design, 50 participants with diplegic CP from the ages of 4 and 6 years evaluated in a physical therapy outpatient clinic and receiving a physiotherapy program for at minimum 6 months were included

Brief summary: Evaluating and applying an early and consistent rehabilitation approach to children with neurological impairments requires a multidisciplinary approach that involves different specialists, including pediatricians, pediatric neurologists, professional therapists, and pediatric physical therapists. Evaluation is essential to validate the judgment, monitor the source, and evaluate the mechanical function and related difficulties.


Eligibility criteria: Inclusion Criteria:

* children with spastic CP with the capability to keep a standing position alone for at minimum five seconds, and the grade of hypertonicity in the lower extremity varied from grade 1 to grade 2 on the Modified Ashworth Scale with the capability to collaborate and follow directives

Exclusion Criteria:

* Children were excluded If they had a serious neurological condition (epilepsy), orthopedic complications, leg surgery, botulinum toxin treatment in the lower extremity in the last 6 months before the study and suffered from advanced intellectual disability.

Primary outcomes:
measure: The principal purpose of this study is to find the correlation between the clinical measurement scales for gross motor function in young CP children
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05765552: Effects of Dual-Task Training In Individuals With Alzheimer
Official title: Effects Of Dual-Task Training On Balance, Fear Of Falling,Cognitive Functions, Dual-Task Performance, Depression And Quality Of Life In Individuals With Alzheimer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer
Fear of falling
Dual-task
Balance
Cognition
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of dual-task training on balance, fear of falling, cognitive functions, dual-task performance, depression and quality of life in individuals with Alzheimer.

Detailed description: Eligible participants will be randomized to control or dual-task training group.Control group will receive conventional therapy generally consisted of lower and upper range of motion exercises for 30 minutes 2 times a week for 8 weeks.Dual-task training group will receive exercises involving motor-cognitive dual-task exercises for 30 minutes 2 times a week for 8 weeks.Each participant will be assessed before and after the 8 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* having been diagnosed with mild or moderate Alzheimer's disease
* able to walk with or without assistance
* having sufficient visual and auditory ability to perform the cognitive tests
* being fit to perform physical exercises
* being able to participate in proposed interventions and assessments

Exclusion Criteria:

* having a neurological disorder other than Alzheimer
* having any musculoskeletal problems that can affect balance
* having any contraindication to exercise
* functional limitation or sensory impairment that may affect performance
* major depression

Primary outcomes:
measure: Timed Up And Go(TUG)
timeFrame: eight weeks
measure: 5 Times Sit To Stand Test(5XSST)
timeFrame: eight weeks
measure: Cognitive Reserve Index Questionaire(CRIq)
timeFrame: eight weeks
measure: Quality of Life in Alzheimer's Disease(QOL-AD)
timeFrame: eight weeks
measure: Geriatric Depression Scale(GDS)
timeFrame: eight weeks
Secondary outcomes:
measure: Dual-Task Questionnaire(DTQ)
timeFrame: eight weeks
measure: Modified Falling Efficacy Scale(MFES)
timeFrame: eight weeks
measure: Mini Mental Test(MMT)
timeFrame: eight weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Karsiyaka Municipality Day Living Center
state: Karsıyaka
Study officials:
affiliation: Ege University
name: Sevnaz ŞAHIN, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02316652: Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets
Official title: Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 33
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine whether the supplemental use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation.

Detailed description: The purpose of this study is to determine whether the adjunctive use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to scaling and root planing alone. The chemical pocket disinfection therapy consists of delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to the test site. Pro-inflammatory interleukin-1 beta and anti-inflammatory interleukin-1 receptor antagonist will be measured from the gingival crevicular fluid sampled from sites of interest.

Eligibility criteria: Inclusion Criteria:

* Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing

Exclusion Criteria:

* Uncontrolled diabetics
* Regular users of nonsteroidal antiinflammatory drugs
* Individuals on anti-coagulants
* Individuals that have used antibiotics in the previous 3 months or require prophylactic antibiotic coverage
* Pregnant individuals

Primary outcomes:
measure: Probing depths
timeFrame: 3 months
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 3 months
measure: Clinical attachment level
timeFrame: 3 months
measure: Inflammatory markers
timeFrame: 3 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: UNMC College of Dentistry
state: Nebraska
Study officials:
affiliation: UNMC College of Dentistry
name: Wayne Kaldahl, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04416152: Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function
Official title: Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pelvic organ prolapse, who will undergo or had undergo pelvic reconstruction surgeries.

Brief summary: To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.


Eligibility criteria: Inclusion Criteria:

* Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery
* Women who had undergone pelvic reconstruction surgeries in our hospital

Exclusion Criteria:

* Pregnant woman.

Primary outcomes:
measure: the women's bladder function questionnaire of UDI-6
timeFrame: 10 years
measure: the women's bladder function questionnaire of IIQ-7
timeFrame: 10 years
measure: Change of psychosomatic score
timeFrame: 1 year
measure: Change of Overactive Bladder Symptom Score
timeFrame: 1 year
measure: Change of FSFI score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01041352: Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position
Official title: Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Adverse Effects
Keywords: anaesthesia
laryngeal mask
prone position
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2009-12-31
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.

Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for backsurgery of an espected duration less than 2 hours,
* Age 18-70 years,
* ASA (american society of anaaesthesiology) class 1-2,
* Normal airways

Exclusion Criteria:

* Body mass index \>35
* Expected time of surgery \> 2 hours

Primary outcomes:
measure: time of anaesthesia
timeFrame: 2 years
Secondary outcomes:
measure: adverse effects using the 2 methods
timeFrame: 2 years
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
name: Karsten S Olsen, MD, DMSc
role: STUDY_CHAIR
References:
citation: Olsen KS, Petersen JT, Pedersen NA, Rovsing L. Self-positioning followed by induction of anaesthesia and insertion of a laryngeal mask airway versus endotracheal intubation and subsequent positioning for spinal surgery in the prone position: a randomised clinical trial. Eur J Anaesthesiol. 2014 May;31(5):259-65. doi: 10.1097/EJA.0000000000000004.
Clinical trial NCT00413452: Etanercept SFP in RA Patients
Official title: Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Etanercept
Enbrel
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-12-19
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
* Naïve to etanercept therapy
* Able to self-inject investigational product or have a designee who can do so
* Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria
* Receipt of Corticosteroids\> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
* Receipt of MTX witin 30 days of 1st dose of investigational product
* Receipt of an other investigational drug within 30 days of 1st dose
* Receipt of TNF inhibitor therapy within 90 days of 1st dose
* Receipt of cyclophosphamide within 6 mo of 1st dose
* Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
* Current use of insulin
* gnificant concurrent medical condition

Primary outcomes:
measure: Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)
timeFrame: 24 weeks
Secondary outcomes:
measure: Etanercept seroreactivity response to etanercept (manufactured using the SFP)
timeFrame: week 12
measure: neutralizing antibodies to etanercept
timeFrame: week 12 and 24
measure: Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments
timeFrame: week 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05948852: Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)
Official title: Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Keywords: OAGB
SADIS
bariatric surgery
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 96
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: This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 and under 65 who meet criteria for bariatric surgery.
* Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
* Signature of the informed consent of the study
* Patients suitable for laparoscopic surgery

Exclusion Criteria:

* Previous bariatric surgery
* 2-stage surgery
* Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
* Other associated surgical procedures in the same intervention.
* Conversion to laparotomy

Primary outcomes:
measure: the percentage of total weight loss (%TWL) of the patients after surgery
timeFrame: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Secondary outcomes:
measure: % of patients with gastroesophageal reflux (acid and bile) after surgery
timeFrame: 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
measure: Number of deaths in the immediate postoperative period
timeFrame: up to day 90 post-intervention
measure: Number of Participants with complications in the immediate postoperative period
timeFrame: up to day 90 post-intervention
measure: Ratio of patients with more than 3 loose stools per day
timeFrame: 1 year, 3 years, 5 years after the surgery
measure: questionnaire of quality of life
timeFrame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
measure: Number of patients with nutritional deficiencies
timeFrame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00252252: AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation
Official title: Crossover Trial of VPAP (Variable Positive Airway Pressure) Ventilation Versus AutoVPAP in Neuromuscular and Chest Wall Disease: Effects on Nocturnal Hypoventilation, Sleep Quality and Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chest Wall Disorder
Neuromuscular Disease
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2005-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 \> 6.5 kPa when breathing spontaneously) with
* Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
* Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
* All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403.
* Able to understand treatment and protocol

Exclusion Criteria:

* Unstable respiratory failure (PaO2 \< 7.5 kPa, PaCO2 \> 8.0 kPa,
* Uncontrolled heart failure or arrhythmia
* Moderate or severe bulbar weakness.
* Unable to understand treatment or protocol

Primary outcomes:
measure: Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
Secondary outcomes:
measure: Compare tolerance of AutoVPAP versus standard VPAP
measure: Compare effects on overnight heart rate variation (as a measure of autonomic stress)
measure: Measure of hours of use of device
measure: Measure of effect on daytime sleepiness
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: Greater London
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Anita Simonds, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaye J, Chatwin M, Dayer M, Morrell MJ, Simonds AK. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial. Eur Respir J. 2009 Mar;33(3):566-71. doi: 10.1183/09031936.00065008.
Clinical trial NCT04068870: Testing a Modified Family Planning Intervention for Postpartum Women in Uganda
Official title: Modification of an Evidence-based Family Planning Intervention for a New Target Population: Postpartum Women in Nakaseke District, Uganda - Pilot Phase, Two Arm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Contraceptive Usage
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: African Community Center for Social Sustainability
First posted: 2019-08-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether offering incentives to encourage women to attend one-on-one family planning education sessions and offering free, onsite prescription contraceptive methods increases use and continuation of prescription contraception among postpartum women in Uganda. This intervention is modified from one that has been effective outside of Uganda.


Eligibility criteria: Inclusion Criteria:

* 18-45 years of age
* Not planning on getting pregnant in the next 4 months
* Less than 3 months postpartum
* No history of tubal ligation or hysterectomy
* No recent prescription contraceptive use (no pill, intrauterine device or implant use in the past 7 days or injection use in the past 3 months)
* Medically eligible to use prescription contraceptives
* Bringing baby to immunization clinic for the first time

Exclusion Criteria:

* Failure to meet the aforementioned inclusion criteria

Primary outcomes:
measure: Period prevalence use of a prescription contraceptive
timeFrame: 6 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Nakaseke
country: Uganda
facility: Nakaseke District Hospital
Study officials:
affiliation: University of Vermont
name: Sarah Heil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940170: Clinical Effectiveness of(VistaProof)in Comparison With ICDAS-II & Histological Validation for Detecting Occlusal Caries
Official title: Clinical Effectiveness of Quantitative Light Fluorescence Based Device (Vistacam Proof) in Comparison With ICDAS-II and Histological Validation in Detection of Initial Pits and Fissures Caries:: Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Light Fluorescence Device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian population

Brief summary: a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries


Eligibility criteria: Inclusion Criteria:

* Patients aged from 15 to 50 years.
* Patient at least has one posterior pits and fissure occlusal caries.
* No gender restriction
* Co-operative patients who signed the informed consent.
* Good general health
* Acceptable oral health

Exclusion Criteria:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.

Primary outcomes:
measure: pits and fissure caries
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
Study officials:
References: