louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06676332: Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia
Official title: Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spastic Diplegia
Motor Imagery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE:

The current study aims to:

* Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia.
* Determine the effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia.

BACKGROUND: Multisensory motor imagery training has an effect on muscle performance and coordination in children with spastic diplegia

HYPOTHESES: There will be no effect of multisensory motor imagery training on muscle performance, coordination and strength and agility in children with spastic diplegic CP.

RESEARCH QUESTION: Is there an effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia?


Eligibility criteria: Inclusion Criteria:

* Their age will be ranged from 8-12 years.
* Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale
* Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
* They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

* - Cardiovascular or respiratory disorders.
* Botulinium muscular injection in the last 6 months
* Surgical interference in lower limbs and/or spine.
* Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
* Seizures.
* Visual or hearing impairment

Primary outcomes:
measure: muscle performance
timeFrame: through study completion average 3 months
measure: coordination
timeFrame: through study completion average 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mayada Elshahawy
Study officials:
References:
Clinical trial NCT01229332: A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
Official title: A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: Motor fluctuations levodopa pharmacokinetics carbidopa solution continuous
Lead sponsor: NeuroDerm Ltd.
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.


Eligibility criteria: Inclusion Criteria:

1. Men and women with idiopathic Parkinson's disease
2. Subjects must experience motor fluctuations associated with LD/CD dosing
3. Modified Hoehn and Yahr stage \< 5
4. Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
5. Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
6. Subjects must be age 30 or older.
7. Subjects must be willing and able to give informed consent.

Exclusion Criteria:

1. Subjects with a clinically significant or unstable medical or surgical condition
2. Subjects with clinically significant psychiatric illness.
3. Pre-menopausal women, not using birth control method.
4. Subjects who have taken experimental medications within 60 days prior to baseline.
5. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).

Primary outcomes:
measure: Incidence and frequency of adverse events, withdrawal rate
timeFrame: Up to 2 days
Secondary outcomes:
measure: Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
timeFrame: Up to 2 days
measure: Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT04215432: Propolis Extract, Nanovitamin C and Nanovitamin E in Peri-implant Mucositis
Official title: Effect of Propolis Extract, Nanovitamin C and Nanovitamin E in Clinical and Microbiological Parameters of Peri-implant Mucositis: A Double-blind, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: dental implants
peri-implant mucosits
toothpaste
propolis
nanovitamin
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Bio Nature Essences S.L
First posted: 2020-01-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to perform the first clinical trial to evaluate the effectiveness of propolis extract, nanovitamin C and nanovitamin E gel as adjuvant to mechanical debridement in clinical and microbiological parameters of implants with peri-implant mucositis


Eligibility criteria: Inclusion Criteria:

* cooperative adult patients,
* with one or more implants with peri-implant mucositis, and
* presenting at least 18 months of functional loading.

Exclusion Criteria:

* refuse to participate in the study,
* patients who had implants with peri-implantitis (BOP and/or suppuration together with progressive radiographic marginal bone loss),
* patients with uncontrolled periodontitis (presence of nine or more sites with PD ≥ 5 mm and with full-mouth bleeding score (FMBS) \> 25%),
* systemic diseases or conditions that could alter the results of the study (diabetes mellitus, immunosuppression, infectious diseases, rheumatoid disease, history of bisphosphonate treatment, radiotherapy, chemotherapy, etc.),
* patients who had taken local and/or systemic antibiotics less than 2 months ago,
* pregnant or breastfeeding women, and
* patients with history of allergies to the test and/or placebo components administered.

Primary outcomes:
measure: Changes in bleeding on probing
timeFrame: baseline and 1-month follow-up
Secondary outcomes:
measure: Changes in probing depth
timeFrame: baseline and 1-month follow-up
measure: Changes in plaque index
timeFrame: baseline and 1-month follow-up
measure: Changes in microbilogical sample
timeFrame: baseline and 1-month follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References:
Clinical trial NCT02689232: TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
Official title: TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Variceal Bleed
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 96
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: DIAGNOSTIC

Brief summary: All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.


Eligibility criteria: Inclusion Criteria:

* Age more than 18
* All patient with Non Variceal bleed (INR\>1.8 and platelets\<50000)
* Hist logical or imaging proven liver cirrhosis.

Exclusion Criteria:

1. Variceal Bleed,
2. Pregnancy.,
3. Patients on anticoagulation
4. Patients who refused to participate in the study
5. Post EVL ulcer bleed

Primary outcomes:
measure: Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
timeFrame: 42 days
Secondary outcomes:
measure: Number of patients with bleed in both groups
timeFrame: 5 days
measure: Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
timeFrame: 42 days
measure: Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
timeFrame: 42 days
measure: Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
timeFrame: 42 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Juned Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.
Clinical trial NCT00444132: Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Official title: Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clopidogrel Non-Responsiveness
Keywords: clopidogrel
platelets
acute coronary syndrome
percutaneous coronary intervention
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease. In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients who demonstrate non-responsiveness to clopidogrel.

Detailed description: Prior studies have demonstrated significant variability in platelet response to clopidogrel in patients with coronary artery disease (CAD). Up to 25% of patients have been shown to be non-responders to a conventional dose of clopidogrel. This phenomenon has been associated with higher incidence of recurrent cardiovascular (CVS) adverse events in patients with acute coronary syndrome (ACS), and higher incidence of peri-procedural myocardial damage, thrombotic complications, and ischemic events in patients undergoing elective percutaneous coronary intervention (PCI). Both the ex-vivo anti-platelet effect and the clinical benefit of clopidogrel are dose related. Moreover, in patients sustaining ACS while on maintenance clopidogrel treatment, reloading with 600 mg clopidogrel, resulted in further reduction in platelet aggregation, although the patients were not non-responders. Despite this, the effect of dose escalation has never been examined in patients resistant to clopidogrel. In the present study we wish to assess prospectively the effect of reloading with 600 mg clopidogrel, and double dose maintenance treatment (150 mg/day) for one month in acute myocardial infarction (AMI) patients who demonstrate non-respondese to clopidogrel.

Eligibility criteria: Inclusion Criteria:

* age equal or over 18 years
* acute coronary syndrome
* Clopidogrel non-responsive
* signed an informed consent

Exclusion Criteria:

* Bleeding disorder
* hypersensitivity to aspirin or clopidogrel
* any contraindication to anti-thrombotic or anticoagulant therapy
* active neoplastic disorder

Primary outcomes:
measure: Platelet reactivity
Secondary outcomes:
measure: recurrent ACS
measure: stroke
measure: death
Other outcomes:
Locations:
city: Tel-hashomer, Ramat Gan
country: Israel
facility: ICCU, Sheba Medical Center
Study officials:
affiliation: Senior Physician, ICCU, Sheba Medical Center.
name: Shlomi Matetzky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233532: Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)
Official title: A Prospective, Open-Label Study to Evaluate the Effect of an Escalating Dose Regimen of Trandolapril on Blood Pressure in Treatment-Naïve and Concurrently Treated Hypertensive Patients (TRAIL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Trandolapril
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 2000
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: The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Stage 1 or 2 Hypertension

Exclusion Criteria:

* Uncontrolled diabetes
* Subject has a hypersensitivity to ACE inhibitor

Primary outcomes:
measure: Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure
timeFrame: 14 weeks
Secondary outcomes:
measure: Changes in blood pressure, safety.
timeFrame: 14 and 26 weeks
measure: BP mmHg incremental and absolute change
timeFrame: 14 and 26 weeks
measure: Adverse events
timeFrame: Throughout 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Global Medical Information 1-800-633-9110
role: STUDY_DIRECTOR
References:
Clinical trial NCT00719732: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Official title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: ReSTOR Aspheric +3 IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cataracts

Exclusion Criteria:

* Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
* \<1 diopter astigmatism by keratometry readings.

Primary outcomes:
measure: Uncorrected Visual Acuity (UCVA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT02466932: Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
Official title: Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Weight
Lead sponsor: Neon Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2015-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children aged between 3-6- preschoolers- born at term and have birth weight heavier than 2500g

Brief summary: This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were measured by GD-SA and relationships between all anterior segment parameters obtained by this device and birth weight were analyzed.

Detailed description: Preschoolers, who were born heavier, had thicker cornea and lens, longer axial length, and flatter corneal curve. The thicknesses and axial curves of central cornea within 7mm may be particularly associated with BW.

Eligibility criteria: Inclusion Criteria:

* ages 3- 6 years;
* birth weight \>2,500 g;
* gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) \>37 weeks;
* visual acuity \>0.8 (in decimals);
* no history of any systemic or ocular diseases;
* no history of previous ocular surgeries;
* no retinopathy of prematurity;
* no current medications; and
* no retinal or optic disc abnormalities on fundoscopy.

Exclusion Criteria:

* ages \<3 \>6 years;
* birth weight \<2,500 g;
* gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) \<37 weeks;
* visual acuity \<0.8 (in decimals);
* history of any systemic or ocular diseases;
* history of previous ocular surgeries;
* retinopathy of prematurity;
* current medications; and
* retinal or optic disc abnormalities on fundoscopy.

Primary outcomes:
measure: Measurements of anterior segment parameters in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06626932: Implications of Biological and Procedural Factors of 18-f FDG Uptake by Normal Organs and Neoplastic Lesions
Official title: Implications of Biological and Procedural Factors of 18-f FDG PET/CT Uptake by Normal Organs and Neoplastic Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oncologic Diseases
Keywords: 18-f FDG PET/CT
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 259
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all cancer patients

Brief summary: To evaluate implications of biological and procedural factors of 18-f FDG PET/CT uptake on normal organs and neoplastic lesions.

Detailed description: 18-f FDG is used on oncological patients undergoing PET/CT study at our nuclear medicine unit , its uptake by the tissues depends on glucose blood level and consumption then we evaluate the implications of biological and procedural factors on the uptake by normal organs and neoplastic lesions using standardized uptake values SUVmax , mean and peak.

Eligibility criteria: Inclusion Criteria:

* cancer patients referred to nuclear medicine unit

Exclusion Criteria:

* patients with increased FDG uptake associated with non malignant causes such as diffuse bone marrow FDG uptake or lung infection or patients with extensive metastasis in target organs

Primary outcomes:
measure: PET/CT scan on cancer patient will be performed to evaluate the biological and procedural factors of 18-f FDG uptake by multiple normal organs and neoplastic lesions using Standardized uptake values
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00042432: Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Official title: A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-08-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.


Eligibility criteria: Inclusion Criteria:

* Patients must have chronic renal insufficiency (pre-dialysis)
* Have below normal creatinine clearance
* Have elevated parathyroid hormone levels

Exclusion Criteria:

* Pregnant or nursing
* Heart attack in the last 3 months.

Primary outcomes:
measure: Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
timeFrame: Efficacy assessment phase (weeks 12-18)
Secondary outcomes:
measure: Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
timeFrame: Baseline, efficacy assessment phase (weeks 12-18)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. doi: 10.1053/j.ajkd.2005.04.013.