louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01667913: Reliability of 6-Minutes Walking Test in Hip Fracture Patients
Official title: The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fracture
Keywords: Hip Fracture
6-minutes walking test
Reliability
Lead sponsor: Lolland Community, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
name: University of Southern Denmark
First posted: 2012-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to examine the relative (ICC) and absolute intertester reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient facility. The data collection is conducted by two physiotherapists, who are blinded to each other. The physiotherapists are randomized so they each are doing an equal number of baseline tests.


Eligibility criteria: Inclusion Criteria:

* 60 years or above
* Hip fracture patients with a Intra - or Extra Capsular hip fracture
* Testing within 3 - 5 weeks postsurgery in an outpatient facility
* No weightbearing restrictions on the fractured limb
* Normal cognitive level (Mini Mental State Examination(MMSE) - score ≥20 points)
* Participants should not experiencing hip related pain more or less than moderate according to Verbal Ranking Scale when resting
* To have the ability to write and understand danish language

Exclusion Criteria:

- MMSE score ≤19 points

Primary outcomes:
measure: The 6-Minutes Walking Test
timeFrame: 3 to 5 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Maribo
country: Denmark
facility: Health Center Maribo
Study officials:
affiliation: Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark
name: Jan A Overgaard, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
name: Morten T Kristensen, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT03906513: Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
Official title: Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea
Keywords: Cornea
Diabetes
Neural damage
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.

Detailed description: This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry \< 45 mm \[6\] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).

Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted.

The randomization will be operator-masked.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation

Exclusion Criteria:

* Neuropathy of any other cause than diabetes
* A history of conditions known to affect corneal sensitivity
* Coexisting other corneal diseases
* Autoimmune diseases
* Sjogren syndrome
* History of corneal trauma
* Contact lenses users
* Patients needing eye surgery or who received eye surgery at least 180 days before study beginning.
* contraindications to the use of any active substances and/or excipients
* pregnant and lactating women
* pediatric patients or adolescents under 18 years

Primary outcomes:
measure: changes in the characteristics of the subbasal corneal plexus at confocal
timeFrame: Change measure (baseline and month 18)
Secondary outcomes:
measure: - changes in clinical signs and symptoms of ocular surface damage
timeFrame: Change measure (baseline and month 18)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Ospedale San Paolo
state: MI
Study officials:
affiliation: University of Milan
name: Paolo Fogagnolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fogagnolo P, Melardi E, Tranchina L, Rossetti L. Topical citicoline and vitamin B12 versus placebo in the treatment of diabetes-related corneal nerve damage: a randomized double-blind controlled trial. BMC Ophthalmol. 2020 Aug 1;20(1):315. doi: 10.1186/s12886-020-01584-w.
Clinical trial NCT04404413: High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
Official title: Effect of High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Physical Performance
Intermittent Fasting
Lead sponsor: University of Alicante
Sponsor class: OTHER
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2020-05-27
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to compare the body composition and physical performance effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance (Hand-grip strength, Counter movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in between both phases when they did not perform the scheduled activity, so as not to alter the experimental phase.


Eligibility criteria: Inclusion Criteria:

1. No muscular, ligamentous, bone, nerve or joint pathology incompatible with the training program.
2. Not to present cardiovascular or cardiorespiratory problems.
3. Physically active in the last 5 years, according to the American College of Sports Medicine (ACSM) definition.

Exclusion Criteria:

1. Following pharmacological treatment or supplement.
2. Performing other sports activities that may influence the study results during their participation in the study.
3. Not following training or diet program guidelines or attending scheduled training sessions.

Primary outcomes:
measure: Hand-grip strength
timeFrame: 16 weeks
measure: Counter movement jump (CMJ)
timeFrame: 16 weeks
measure: Wingate Anaerobic 30 s Cycling Test
timeFrame: 16 weeks
measure: Fat mass
timeFrame: 16 weeks
measure: Muscle mass
timeFrame: 16 weeks
measure: Residual mass
timeFrame: 16 weeks
measure: Body Mass
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Vicente Del Raspeig
country: Spain
facility: Alejandro Martínez Rodriguez
state: Alicante
Study officials:
References:
Clinical trial NCT05866913: Neurodynamics vs. Stretching in Soccer Players With Short Hamstring Syndrome
Official title: Effect of Neurodynamics vs Passive Stretching in Federated Soccer Players With Short Hamstring Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Contractures
Keywords: Peripheral nervous system
Muscle stretching exercises
Hamstring muscles
Sciatic nerve
Elasticity
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group. Experimental group 1. Experimental group 2.
Primary purpose: TREATMENT

Brief summary: Comparison of the effects of passive stretching vs. sciatic nerve gliding in soccer players presenting with short hamstring syndrome.

Detailed description: Soccer players from three teams in the region of Murcia (Spain) were recruited and randomly divided into three groups: control group, experimental group 1 and experimental group 2.

In the control group passive shoulder mobilization will be applied, in experimental group 1 sciatic nerve gliding will be applied and in experimental group 2 passive hamstring stretching will be applied.

Treatments will be performed once a week for 4 weeks and measurements will be taken at week 1 and 4.

Eligibility criteria: Inclusion Criteria:

* Soccer players of the Murcia Region Federation who have short hamstring syndrome.
* Between 16 and 30 years of age.
* To complete the informed consent form.

Exclusion Criteria:

* Subjects with significant neurological pathology.
* Subjects with hamstring muscle injury.
* Subjects with lumbar pathology.

Primary outcomes:
measure: Elasticity of the hamstring muscles.
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: Universidad de Murcia
name: Ángel Martínez Carrasco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387113: The PERFusion Use in Stroke Evaluation Study
Official title: Expanding the Time Window for IV Thrombolysis With Rt-PA in Acute Ischemic Stroke Patients Using Computed Tomography Perfusion Imaging: The PERFusion Use in Stroke Evaluation (PERFUSE) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: stroke
tPA
Thrombolysis
rt-PA
Ischemic
CTP
Imaging
CT Perfusion Imaging
Perfusion
CTA
CT Angiography
Acute ischemic stroke
Acute stroke therapy
(AIS)
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: California Pacific Medical Center
First posted: 2011-07-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All acute ischemic stroke patients who present to the emergency room at CPMC who receive IV rt-PA within 6 hours of symptom onset

Brief summary: This is an open label single center phase II trial, evaluating the utility of 64 slice CT perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA) in AIS patients up to 6 hours after symptom onset.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke
* ≥ 18 years old
* presentation up to 6 hours from time of onset of acute stroke symptoms

Exclusion Criteria:

* pregnancy
* inability to receive CT scan
* allergy to IV contrast
* symptoms with full resolution
* intracerebral hemorrhage
* severe stroke which is classified as 'malignant' (hypodensity on noncontrast CT greater than 1/3 cerebral hemisphere)
* premorbid mRS of \>3
* life expectancy of ≤3 months
* any condition which, in the opinion of the investigator makes the subject unsuitable for study

Primary outcomes:
measure: Final infarct volume
timeFrame: 24 hour post-thrombolysis
Secondary outcomes:
measure: Large vessel occlusion on neuroimaging
timeFrame: 24 hours post-thrombolysis
measure: NIHSS
timeFrame: 24-hours from tPA adminsitration
measure: Symptomatic intracerebral hemorrhage post-thrombolysis
timeFrame: 24 hours post-thrombolysis
measure: Modified Rankin Scale
timeFrame: 3-months from tPA administration
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: CPMC
name: Nobl Barazangi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05376813: An Algorithm Creation by Automated Segmentation by MRI for Bone and Muscles of Shoulder
Official title: Elaboration of an Algorithm of Automated Segmentation by Magnetic Resonance Imaging for Bone and Muscles of Shoulder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Reverse Shoulder Prosthesis
Keywords: Reverse Shoulder Prosthesis
Algorithm
Automatic segmentation
Magnetic resonance imaging
Computed tomography
3D imaging
Manual segmentation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: No comparative, no control study
Primary purpose: OTHER

Brief summary: The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.

Detailed description: This is a national monocentric study which will be conducted in Ambroise Paré hospital of APHP, in orthopaedics department (for enrollment) and radiological department (for CT-scan and MRI examinations) respectively.

Manual segmentations of 5 muscles and 2 bones of shoulder by MRI with automated segmentation of shoulders corresponding to CT-scan imagings.

3D imagings of each shoulder by manual segmentations from MRI and automated segmentation from computed tomography will provide to build a network.

The perspective of the elaborated algorithm should lead to an automated 3D-reconstruction of patients' shoulder as a routine care in surgery.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer \> 18 years, presenting any symptom nor history of shoulder pathology;
* Affiliated to social security scheme.

Exclusion Criteria:

* Symptoms or history of shoulder pathologies;
* Claustrophobia;
* Pregnant woman;
* Patient covered by AME system;
* Contre-indication to perform MRI examination (implant, less 6-months stent implantation, recent surgery, renal insufficiency, pace maker implantation, cardiac defibrillator, cardiovascular catheter, neurostimulation, implantable electronic pompe for automatic injection of medications).

Primary outcomes:
measure: Algorithm developement
timeFrame: through study completion, an average of 8 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopaedics, Ambroise Paré hospital, APHP
name: Jean-David Werthel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05579613: Effect of Interactive Virtual Reality Device on Cervical Proprioception and Range of Motion in Forward Head Posture
Official title: Faculty of Physical Therapy, Cairo University, Egypt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Forward Head Posture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forward head posture (FHP) is one of the most common postural deformities, which affects 66% of the patient population and this study will be designed to investigate the effect of interactive virtual reality device on cervical proprioception and range of motion in symptomatic forward head posture.

Detailed description: Thirty subjects of both sex with ages ranging from 20-24 years and BMI ranging from 18-25 kg/m² with symptomatic forward head posture will be participated in this study. They will be assigned randomly to two groups. Group A will receive traditional treatment (chin tuck exercise for posture correction); 3 min each day for 4 weeks, three sets of 10 repetitions (each repetition was held for 5 sec) were performed. Group B will receive the same as group "A" and received VR training by Xbox Kinect 360 (15 min per session 3 times per week) for 4 weeks. Cervical joint position error (JPE) (CROM device) and cervical range of motion will be measured pre and post treatment.

Eligibility criteria: Inclusion Criteria :

1. Subject's age range from 18-24 years old distance of ≥ 2 cm between the acromion and the earlobe when they were positioned perpendicular to the ground.( Kim et al 2018).
2. Prolonged neck pain for more than three months; and the Neck Disability

Exclusion Criteria:1- Existing vestibular pathology.

2- Cervical fracture/dislocation. 3- Sys- temic diseases. 4- Neurological/cardiovascular/respiratory disorders affecting physical performance.

5- History of traumatic head injury. 6- Pregnancy.

-

Primary outcomes:
measure: Cervical propriception
timeFrame: 4 weeks
measure: Cervical range of motion
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ibtsam Abdelkarim
Study officials:
References:
Clinical trial NCT05614713: Effect of Sensory Integration Therapy on Balance and Functional Mobility
Official title: Effect of Sensory Integration Therapy on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group and control group
Primary purpose: TREATMENT

Brief summary: Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test.

Detailed description: Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test. The control group received selected physical therapy, while the study group received the previously mentioned selected physical therapy program modified to increase sensory input. Treatment sessions for both groups were conducted for both groups for 1 hour once a day, three times per week for two successive months.

Eligibility criteria: Inclusion Criteria:

Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system

Exclusion Criteria:

Visual or auditory problems. Fixed deformities of lower limbs.

Primary outcomes:
measure: Assessment of balance
timeFrame: After 2 months of intervention
measure: Assessment of functional mobility
timeFrame: After 2 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Mai E Abbass, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02884713: Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia
Official title: Efficacy of Levofloxacin-Doxycycline Based Rescue Therapy for Helicobacter Pylori Eradication: A Prospective Open-label Trial in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GASTRITIS
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 55
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: Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy. Different second-line therapeutic options are available. However, the success of second-line therapy has not been addressed or reported from Saudi Arabia.

Objectives The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment.

Detailed description: A prospective, open-label, single arm study was conducted. Patients were recruited from a tertiary care hospital in Saudi Arabia from June 2013 to April 2014. A total of 55 patients had previously received standard triple therapy and/or sequential therapy in the period from 2011 to 2014 and failed to eradicate the infection. The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily. Urea-breath-test (UBT) was done at a minimum of 6 weeks after completion of the treatment to confirm the H. pylori eradication. Compliance and tolerability of the regimen were also assessed.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Received previous treatment with triple therapy, sequential therapy or both
* Has evidence of persistence H. pylori infection by a positive urea breath test (UBT), histology or rapid urease test (HP Fast. GI supply™, PA, USA)

Exclusion Criteria:

* Previously treated with quadruple or levofloxacin-based therapy
* Had an allergy to doxycycline, levofloxacin or esomeprazole
* Pregnant or lactating
* Significant hepatic, renal, or cardiopulmonary disorders, or active malignancy.

Primary outcomes:
measure: Eradication rate of second line levofloxacin- doxycycline based therapy for H. pylori eradication after failed fisrt line therapy using Urea Breath Test and its association with symptoms resolution.
timeFrame: 6 weeks
Secondary outcomes:
measure: Symptoms response to treatment
timeFrame: 6 weeks
measure: Factors associated with eradication of H.pylori
timeFrame: 6 weeks
measure: Adverse events associated with the treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References: