louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06531044: Relationship Between Gross Motor Coordination and Balance in Children With Spastic Cerebral Palsy
Official title: Relationship Between Gross Motor Coordination and Balance in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Balance
Gross Motor Coordination
Lead sponsor: Sinai University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with spastic cerebral palsy

Brief summary: This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities.

Detailed description: PURPOSE:

To examine the relationship between the gross motor coordination and balance in children with spastic cerebral palsy.

BACKGROUND:

Motor coordination is required for the effective acquisition of movements and effortless performance. Gross motor coordination involves numerous skills, including balance, bilateral movement, agility, and speed. Children with cerebral palsy exhibit a deterioration in gross motor coordination ability.

The lack of postural control in children with cerebral palsy impairs functional balance. According to studies, children with cerebral palsy have poorer static and dynamic balance responses than typically developing children.

HYPOTHESES:

- There is no relationship between gross motor coordination and balance in children with spastic cerebral palsy.

RESEARCH QUESTION:

- Is there a relationship between gross motor coordination and balance in children with spastic cerebral palsy.

Eligibility criteria: Inclusion Criteria:

1. They were scored Level I on the Gross Motor Function Classification System (GMFCS).
2. The subjects' age was from five to eleven years.
3. They were at least 1-meter-tall and not less 20 Kg.
4. They had to comprehend verbal commands.
5. They were score 1 to 1+ based on Modified Ashworth' Scale.

Exclusion Criteria:

1. Contracture, deformity and/or tightness in upper or lower limbs.
2. Botulinum toxin in the last year.
3. Recent fracture.
4. Vertigo or dizziness.
5. Epilepsy.
6. Osteoporosis.
7. Recent operation in the six months at least (according to the type of operation).

Primary outcomes:
measure: balance.
timeFrame: 1 day - one session
measure: gross motor coordination.
timeFrame: 1 day - one session
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Sinai University
Study officials:
References:
Clinical trial NCT03390244: Foldable Capsular Vitreous Body Implantation Study
Official title: Foldable Capsular Vitreous Body Implantation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreoretinal Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 2
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: This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18
* Axial length between 16 and 28 mm (according the guidelines from the manufacturer)
* Loss of functional vision in study eye
* Visual acuity of 0.4 or better in fellow eye
* Requirement of (repeated) long-term silicone oil tamponade to maintain eye pressure and keep the retina attached

Exclusion Criteria:

* Visual acuity beyond 0.4 in non-study eye
* Severe general disease that is evaluated to impact live expectancy beyond the duration of the study follow-up (3 years)
* Retinal detachment under silicone oil fill
* Patients with a silica gel allergy or scar diathesis
* Patients with serious heart, lung, liver, or kidney dysfunction
* Patients with proliferative diabetic retinopathy, endophthalmia, uveitis and other uncontrollable eye diseases, or a contralateral eye that had intraocular retinal surgery
* Patients with history of drug abuse or alcoholism
* Patients are had participating in other drug or medical device clinical trials before screening for this trial
* Pregnancy, preparation for pregnancy during clinical trial, or breast-feeding
* Belief by any of the research doctors that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

Primary outcomes:
measure: Intra-ocular pressure
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven (UZLeuven)
state: Vl-Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Stalmans, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06286644: Hop Compounds on the Immune System (VH)
Official title: Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Response
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours.

Detailed description: In this placebo-controlled crossover study a study drink enriched with either a placebo, Xanthohumol, Iso-alpha Acids or a combination of latter is given to the participants. A washout phase before intervention and between each intervention is introduced. On day one of each intervention blood is drawn in fasted state from each participant. Subsequently the study drink combined with a standardized breakfast is given to the participants followed by blood draws 1, 2, 3, 4 and 6 hours after the consumption of the study drink. To assess the effect of Xanthohumol and Iso-alpha acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* healthy
* BMI: \>18,5 kg/m² or \<30 kg/m²

Exclusion Criteria:

* food intolerances
* food allergies
* chronic inflammatory diseases
* metabolic diseases
* viral or bacterial infections within the last 3 weeks of inclusion
* intake of immunosuppressive medication

Primary outcomes:
measure: Changes in parameters of immune response
timeFrame: 6 hours
measure: Changes in parameters of immune response
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
Clinical trial NCT02108444: Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients
Official title: Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients With Hepatitis B Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Hepatitis B
Lymphoma
Hematologic Diseases
Keywords: hepatitis
hepatitis B
lymphoma
Hematologic Diseases
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lymphoma patients with hepatitis B virus infection diagnosed in Peking University Cancer Hospita

Brief summary: This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.

Detailed description: All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.

Eligibility criteria: Inclusion Criteria:

* treatment-naive patients with lymphoma
* patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive

Exclusion Criteria:

* HBsAg and HBcAb negative

Primary outcomes:
measure: the incidence of hepatitis B virus delayed reactivation
timeFrame: within one year after withdrawal of prophylactic antiviral therapy
Secondary outcomes:
measure: the incidence of hepatitis B virus related hepatitis flare
timeFrame: within one year after withdrawal of prophylactic antiviral therapy
measure: Number of patients that achieve a tumor response
timeFrame: within one year after withdrawal of prophylactic antiviral therapy
measure: overall survival rate
timeFrame: within one year after withdrawal of prophylactic antiviral therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT05595044: Effect of Vitamin D Therapy in Autism Spectrum Disorder
Official title: Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Effect of Drug
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups. One group receiving vitamin D plus habilitation and the other group receiving habilitation only
Primary purpose: TREATMENT

Brief summary: The aim of this work is to study the adjuvant effect of vitamin D supplementation on inflammatory marker (IL4) and habilitation outcome in children with Autism Spectrum Disorder in order to evaluate its efficiency as a treatment option based on correction of immune dysfunction.

Detailed description: Vitamin D is one of environmental factors potentially modulating brain development and functioning. Vitamin D3 deﬁciency during pregnancy and early childhood is suggested to be one of several risk factors for development of ASD in genetically predisposed individuals (Cies´lin´ska et al., 2017). Many studies e.g (Eyles et al., 2013; Grant and Sole, 2009; Noriega and Savelkoul, 2014) suggested that vitamin D has an important role as a neuroactive steroid, which can affect neuronal differentiation, axonal connectivity and brain structure and function. Vitamin D has been increasingly recognized for its immunomodulatory role and has been implicated in the pathogenesis of autoimmune disorders. Also it has numerous and dynamic effects on the immune system, ranging from altering T cell responses and regulating cytokine pathways (Kocˇovská et al., 2017). So from this point of view, this study will be conducted to show adjuvant effect of vitamin D supplementation on ASD children at clinical level and inflammatory marker (IL4).

Eligibility criteria: Inclusion Criteria:

1. Delayed language development due to ASD.
2. Good nutritional status (Normal weight and height using growth charts, no Anemia and no clinical evidence of vitamin deficiency).
3. Normal hearing and vision.

Exclusion Criteria:

1. History of vitamin D supplementation, drugs modulating immune system as steroid and drug formula containing vitamin D as cod liver oil.
2. Known chronic disease.
3. Known neurological disorders or psychiatric disorders.
4. Known autoimmune or gastrointestinal disorders.

Primary outcomes:
measure: language ability test
timeFrame: 4 months
measure: CARS questionnaire for assessment of ASD severity
timeFrame: 4 months
measure: Inflammatory marker
timeFrame: 4 months
measure: Serum vitamin D
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
Study officials:
affiliation: Phoniatric unit, ORL department, faculty of medicine, Mansoura university
name: Amira M. Mansour, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724744: Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women
Official title: Effect of Manual Diaphragmatic Release on Ventilatory Functions and Functional Capacity in Elderly Diabetic Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Elderly
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.

Detailed description: Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups.

The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed:

1. Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second).
2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic for more than 5 years.
* Well controlled diabetes with glycated hemoglobin≤7%.
* Normal to mild ventilatory functions impairment.
* Their ages ranges from 65 to 70 years old.
* Their body mass index are less than 30 Kg/m2.

Exclusion Criteria:

* Other types of diabetes.
* Patients with any other chronic chest diseases .
* Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
* Smokers.
* Rheumatoid arthritis.
* Musculoskeletal/ neurological limitations to exercise.

Primary outcomes:
measure: Ventilatory functions
timeFrame: At baseline and after 12 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: At baseline and after 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Endocrinology outpatient clinic at Mansoura University
state: Dakahlya
Study officials:
affiliation: Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University Amman Jordan
name: Saher Lotfy Elgayar, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04018144: Running Title: PPAR-γ, RXR-α, and VDR Expressions in Periodontitis
Official title: PPAR-γ, RXR-α, and VDR Expressions in Periodontitis Patients With Different Stage and Grade Involvement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Keywords: Periodontitis, PPAR-γ, RXR-α, VDR
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Three study groups were created, and 45 participants were enrolled in the present study.

The study groups were; Group-1; healthy individuals (mean age 42.34±3.89, nine women, six men) Group-2; periodontitis patients-stage 3 grade B, (GradeB) (mean age 43.12±3.16, 10 women, 5 men) Group-3; periodontitis patients-stage 3 grade C, (GradeC) (mean age 42.78±2.99, 10 women, 5 men)

Brief summary: Objective: The present study aimed to determine the expressions of nuclear receptors PPAR (Peroxisome proliferative activator receptor)-γ, RXR (Retinoid X receptor)-α, and vitamin D receptor (VDR) in healthy volunteers and periodontitis patients with different grade involvement.

Methods: Group-1; healthy individuals, Group-2; periodontitis patients-stage 3 grade B, (H-GradeB), Group-3; periodontitis patients-stage 3 grade C, (D-GradeC). Clinical parameters as plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were measured. Fibroblast and inflammatory cells, PPAR-γ, RXR-α, and VDR levels were determined in histological slides.


Eligibility criteria: Inclusion Criteria:

* systemic health
* no drug use
* no previous periodontal treatment within six months
* no tobacco use

Exclusion Criteria:

* pregnant or lactating women
* patients used antibiotics in the last 6 months

Primary outcomes:
measure: Inflammatory cell counts
timeFrame: During histological tissue processing
measure: Fibroblasts counts
timeFrame: During histological tissue processing
measure: PPAR (Peroxisome proliferative activator receptor)-γ
timeFrame: During histological tissue processing
measure: RXR (Retinoid X receptor)-α
timeFrame: During histological tissue processing
measure: Vitamin D receptor (VDR)
timeFrame: During histological tissue processing
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT01812044: Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Official title: Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.


Eligibility criteria: Inclusion Criteria:

* Age 1 year to \< 8 years
* Undergoing strabismus surgery under general anesthesia
* No previous surgery on muscle to be operated
* No known allergy to lidocaine or bupivacaine
* Investigator willing to inject subtenons NS or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or Hypromellose 0.3% gel (GenTeal Severe Dry Eye Relief) to all surgical wounds at the end of strabismus surgery.

Primary outcomes:
measure: Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
timeFrame: 0-30 minutes post-operative
Secondary outcomes:
measure: Peak Pain Score
timeFrame: 0-150 minutes post-operative
measure: Total Narcotic Use During Post-operative Recovery
timeFrame: Total time in post-operative recovery - up to 6 hours
measure: Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)
timeFrame: 1 week (+/- 3 days) post operatively
measure: Average Time to Discharge
timeFrame: 0-150 minutes post-operative
measure: Number of Participants With Post Operative Nausea and Vomiting
timeFrame: 0-150 minutes post-operative
measure: Number of Participants Who Required Anti-emetic Medication Post-operatively
timeFrame: Total time in post-operative recovery - up to 6 hours
measure: Peak Pain Score During First 30 Minutes
timeFrame: 0-30 minutes post-operative
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke Eye Center
name: Laura Enyedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368444: A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
Official title: A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Posttraumatic Stress
Sleep
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms.

Detailed description: The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms. The total length of the program will be 8 weeks. The sessions will be held 3 hours per week with 1.5 hours of group cognitive behavioral therapy and 1.5 hours of yoga. Changes in PTSD symptoms and sleep quality will be measured at baseline, immediately following the program, and at 2 month follow-up.

Eligibility criteria: Inclusion Criteria:

* clinically diagnosed posttraumatic stress disorder (PTSD) or subthreshold PTSD symptoms

Exclusion Criteria:

* current uncontrolled psychotic or bipolar disorder, significant cognitive impairment, substance dependence, non-English speaking, or a significant medical condition that would interfere with participation in the yoga portion of the program

Primary outcomes:
measure: Changes in Posttraumatic Stress Symptoms will be measured using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (PCL-5)
timeFrame: Baseline and 8 weeks and 16 weeks
Secondary outcomes:
measure: Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Yoga Studio
state: New Mexico
Study officials:
affiliation: Georgetown University
name: Julie K Staples, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: