louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05391672: Repair Versus Augmentation of Partial ACL Tear
Official title: Repair Versus Augmentation Of Partial Anterior Cruciate Ligament Tear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 72
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between ACL repair and ACL augmentation in symptomatic patients with partial ACL injury


Eligibility criteria: Inclusion Criteria:

* age from 15 to 50 years old
* Partial ACL tear without any other ligament injury
* with and without meniscal tear
* with and without knee deformity
* recent and chronic injury

Exclusion Criteria:

* younger than 15 and older than 50 y
* multiligament injury
* complete ACL tear
* failed ACL reconstruction or repair

Primary outcomes:
measure: The main outcome is difference in IKDC scores between two groups of patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopaedic Department , Faculty of medicine, Assiut University
name: Mohamed Abd-El Radi, Lecturer
role: STUDY_DIRECTOR
References:
citation: Gobbi A, Whyte GP. Long-term Outcomes of Primary Repair of the Anterior Cruciate Ligament Combined With Biologic Healing Augmentation to Treat Incomplete Tears. Am J Sports Med. 2018 Dec;46(14):3368-3377. doi: 10.1177/0363546518805740. Epub 2018 Nov 6.
citation: Dallo I, Chahla J, Mitchell JJ, Pascual-Garrido C, Feagin JA, LaPrade RF. Biologic Approaches for the Treatment of Partial Tears of the Anterior Cruciate Ligament: A Current Concepts Review. Orthop J Sports Med. 2017 Jan 25;5(1):2325967116681724. doi: 10.1177/2325967116681724. eCollection 2017 Jan.
citation: Sabat D, Kumar V. Partial tears of anterior cruciate ligament: Results of single bundle augmentation. Indian J Orthop. 2015 Mar-Apr;49(2):129-35. doi: 10.4103/0019-5413.152394.
citation: Sharp JW, Kani KK, Gee A, Mulcahy H, Chew FS, Porrino J. Anterior cruciate ligament fixation devices: Expected imaging appearance and common complications. Eur J Radiol. 2018 Feb;99:17-27. doi: 10.1016/j.ejrad.2017.12.006. Epub 2017 Dec 9.
Clinical trial NCT04428372: MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)
Official title: MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hemodialysis Complication
Hemodynamic Instability
Keywords: hemodialysis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This proposal will measure the effects of mannitol administration versus placebo in hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in patient symptoms and blood pressure stability.

Detailed description: A randomized crossover trial of hypertonic mannitol vs. placebo in IDH-prone participants will be performed over a 4-week period to determine the effect on:

* Patient symptoms
* The magnitude of intra-dialytic hypotension

The hypothesis to be tested is that the use of hypertonic mannitol will result in fewer adverse symptoms and less decline in intra-dialytic BP, compared with the use of placebo.

Eligibility criteria: Inclusion Criteria:

* Maintenance HD (\>90 days)
* Age ≥18y
* Thrice-weekly HD
* IDH-prone (defined as nadir intra-dialytic SBP \<100 mmHg in ≥30% of sessions in the prior 4 weeks)
* Hematocrit\>21%
* Written informed consent

Exclusion Criteria:

* Acute myocardial infarction or stroke within one month
* Pre-HD serum potassium \>6.5 mmol/L in last 4 weeks
* Pregnancy
* Institutionalized individuals
* Life expectancy \<2 months
* Planned renal transplant within 2 months
* Active enrollment in another interventional trial
* Known allergy to mannitol

Primary outcomes:
measure: Patient Symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient Symptoms
timeFrame: 4 weeks
measure: Patient Symptoms
timeFrame: 4 weeks
measure: Intra-dialytic hypotension
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Finnian R Mc Causland, MBBCH, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753672: Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness
Official title: Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Shock
Lead sponsor: Hopital Antoine Beclere
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.

Brief summary: Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can predict preload unresponsiveness.

Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% (4).

Methods Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.


Eligibility criteria: Inclusion Criteria:

* ADULTS
* Patients presenting with shock or other signs of circulatory failure (tachycardia, oliguria)
* Need for the physician to test preload responsiveness
* Patients already equipped by a central venous catheter for the measurement of CVP

Exclusion Criteria:

* patients\<18 years old
* pregnancy
* instaility justifying rapid increase in cathecolamines

Primary outcomes:
measure: the predictive value of changes in CVP to determine preload responsiveness
timeFrame: ONE MINUTE TEST
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hamzaoui Olfa
Study officials:
References:
citation: Hamzaoui O, Gouezel C, Jozwiak M, Millereux M, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Teboul JL. Increase in Central Venous Pressure During Passive Leg Raising Cannot Detect Preload Unresponsiveness. Crit Care Med. 2020 Aug;48(8):e684-e689. doi: 10.1097/CCM.0000000000004414.
Clinical trial NCT03619772: EMG Training for Altering Activation Patterns After Stroke
Official title: Altering Activation Patterns With EMG Training in the Distal Upper Extremity After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Weakness, Muscle
Coordination Lack
Keywords: hand
stroke
therapy
rehabilitation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: North Carolina State University
name: Marquette University
name: Medical University of South Carolina
First posted: 2018-08-08
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: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.

Detailed description: Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.

Eligibility criteria: Inclusion Criteria:

* Single, unilateral stroke at least 6 months prior to enrollment
* Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale

Exclusion Criteria:

* Visual neglect or deficits (with inability to compensate)
* Upper extremity orthopedic conditions that interfere with movement
* Cerebellar stroke

Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.

Primary outcomes:
measure: Change in mean completion time for timed test
timeFrame: Baseline and 3 weeks (immediately post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Elliot Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22.
Clinical trial NCT02009072: Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
Official title: Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Keywords: Pterygium surgery
Sutureless glue free conjunctival autograft
Amniotic membrane graft.
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Minia University
First posted: 2013-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium.

Detailed description: Design: Prospective randomized clinical trial comparative study. Setting: Department of ophthalmology, Al-Minia University Faculty of medicine, Egypt.

Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74 years of age (mean 49 ± 12 years). Simple excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1), versus sutured free conjunctival autograft in 100 eyes of 100 patients (group 2).

Eligibility criteria: Inclusion Criteria:

Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis.

Exclusion Criteria:

All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head pterygium.

Primary outcomes:
measure: Recurrence Rate
timeFrame: 24 months
Secondary outcomes:
measure: Postoperative signs and symptoms
timeFrame: Third postoperative day,then weekly for one month
measure: Overall patient satisfaction
timeFrame: Third post-operative week
measure: Complications
timeFrame: 24 months
Other outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Gain in uncorrected visual acuity (UCVA)
timeFrame: First post-operative month
Locations:
city: Al Minya
country: Egypt
facility: Shaaban A Elwan
Study officials:
affiliation: Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt
name: Shaaban A Elwan, Assist Prof Ophth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542772: Mirror Therapy Education for Acute Stroke Patients
Official title: Effectiveness of Patient Education on Mirror Therapy to Improve Upper Extremity Function in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Health Sciences North Research Institute
Sponsor class: OTHER
Collaborators: name: NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)
First posted: 2020-09-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?


Eligibility criteria: Inclusion Criteria:

* Admitted with diagnosis of stroke with onset within two weeks
* Medically stable
* Able to follow directions
* No severe cognitive impairments that could interfere with patient participation
* Consent to treatment by patient
* Alpha-Functional Independence Measure (Alpha-FIM) score of \> 40

Exclusion Criteria:

* Medical instability
* Lack of motivation
* Recurrent/ chronic stroke
* Recent upper extremity musculoskeletal injuries with movement restrictions
* Receptive or global aphasia
* Delirium
* Unilateral neglect
* Visual field deficiency.

Primary outcomes:
measure: Fugl-Meyer Assessment scale
timeFrame: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.
measure: Wolf Motor Function Test
timeFrame: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Rajendran V, Jeevanantham D, Lariviere C, Singh RJ, Zeman L, Papuri P. Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol. Trials. 2021 Jul 9;22(1):439. doi: 10.1186/s13063-021-05380-9.
Clinical trial NCT02525172: Immune Modulation Therapy for Pompe Disease
Official title: Immune Modulation Therapy for ERT-naïve or ERT-treated Pompe Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pompe Disease
Keywords: immune modulation therapy
acid α-glucosidase
antibody
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers after treatment with immune modulation therapy in patients of Pompe disease.


Eligibility criteria: Inclusion Criteria:

* The patient (and/or patient's legal guardian if patient is \< 18years) must provide written informed consent prior to any study-related procedures that are performed;
* The patient must have a confirmed diagnosis of Pompe disease defined as a documented acid α-glucosidase (GAA) enzyme deficiency from blood samples or 2 GAA gene mutations;
* The patient (and/or legal guardian) must have ability to comply with clinical protocol;
* Regimen A only: The patient is receiving enzyme replacement therapy, exhibits clinical decline, and has persistent high anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers and/or tested positive for antibodies that inhibit enzymatic activity and/or uptake of Myozyme;
* Regimen B only: The patient is cross-reactive immune material (CRIM) -negative AND have not received Myozyme infusion prior to enrollment

Exclusion Criteria:

* The patient is at risk of reactivation or is a carrier of Hepatitis B or Hepatitis C;
* The patient is at risk of reactivation of tuberculosis or has regular contact with individuals who are being actively treated for tuberculosis;
* The patient has used any investigational product (other than alglucosidase alfa) within 30 days prior to study enrollment;
* The patient is pregnant or lactating;
* The patient has had or is required to have any live vaccination within one month prior to enrollment.

Primary outcomes:
measure: anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers decrease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yin-Hsiu Chien
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Hsiu Chien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04440072: Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index
Official title: Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Atherosclerosis Obliterans
Atherosclerosis Right Leg
Atherosclerosis Left Leg
Keywords: ankle brachial index
color duplex ultrasound
pulsed doppler
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient referred to the Vascular Medicine Department for a vascular examination with ABI measurement. In most cases, these patients present with symptoms suggestive of PAD, most often with vascular risk factors for atherosclerosis.

Brief summary: Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical practice.

The recommended measurement was gradually replaced by colour or pulsed Doppler without validation of these techniques.

The objective of our study is to compare these two techniques (color Doppler and pulsed Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI measurement.


Eligibility criteria: Inclusion Criteria:

Patient referred to the Vascular Medicine Department of Caen University Hospital for a vascular examination with ABI measurement having been informed and not objecting to participation in the study and benefiting from a social protection system.

Exclusion Criteria:

* Patient with arrhythmia
* Patient with trans-tibial or more proximal amputation
* Patient with extensive trophic disorder not allowing measurement
* Patient with subgonal bypass
* Known bilateral sub-clavian stenoses
* Patient deprived of liberty or under a measure of legal protection
* Interned patient for the treatment of a psychiatric or physical illness
* Patients who are legally incompetent, under the protection of justice, under guardianship or trusteeship.

Primary outcomes:
measure: Concordance on the IPS value measured with pulsed Doppler compared to gold standard
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
Study officials:
References:
Clinical trial NCT00230672: Investigation of Plasma Proteins in Patients With Hereditary Haemorrhagic Telangiectasia and PAVMs
Official title: Studies of Plasma Proteins Derived From Pulmonary Arteriovenous Malformation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telangiectasia, Hereditary Hemorrhagic
Keywords: Hereditary Hemorrhagic
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-10-03
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations

Brief summary: Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an disease that leads to the development of dilated and fragile blood vessels, including arteriovenous malformations in the lungs (PAVMs). We hypothesize that the genetically-determined abnormality in the blood vessels of HHT patients leads to alteration in the concentrations or activity of several proteins in the blood stream. We propose to take blood samples from patients at defined times in order to study changes in blood protein levels and activity


Eligibility criteria: Inclusion Criteria:Patients with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations -

Exclusion Criteria:Unable to provide informed consent

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Hammersmith Campus
Study officials:
affiliation: Imperial College London
name: Claire Shovlin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howard LSGE, Santhirapala V, Murphy K, Mukherjee B, Busbridge M, Tighe HC, Jackson JE, Hughes JMB, Shovlin CL. Cardiopulmonary exercise testing demonstrates maintenance of exercise capacity in patients with hypoxemia and pulmonary arteriovenous malformations. Chest. 2014 Sep;146(3):709-718. doi: 10.1378/chest.13-2988.