louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05192993: Effect of Oculomotor Exercise on Writing Capabilities on Autism
Official title: Effect of Oculomotor and Gaze Stability Exercise on Writing Capabilities on Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autism spectrum disorders (ASD)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (DSM-IV). In addition to these core deficits, ASD is associated with a high prevalence of fine motor difficulties and executive function impairments that contribute to acquisition and performance of skilled motor tasks. It is therefore not surprising that handwriting difficulties are frequently reported in children with ASD.

Detailed description: Handwriting is a functional skill that profoundly affects children's academic and psychosocial development. Difficulties in acquiring and applying these skills subsequently lead to problems such as slow writing and illegible written .Such difficulties may have implications on the child's successful participation in school and play activities, potentially leading to problems in academic performance and lowered self-esteem .Therefore, students with handwriting difficulties are especially prone to frustration, disappointment, and under achievement. The aim of our study is to improve handwriting quality of children with ASD.

Eligibility criteria: Inclusion Criteria:

* Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
* Intelligence quotient (IQ) score 70-100.
* Writing difficulties

Exclusion Criteria:

* Middle ear disorders
* Physical or mental conditions that may affect handwriting (e.g., seizures)
* Uncorrected visual or hearing impairments.

Primary outcomes:
measure: gaze stability
timeFrame: 6 weeks
Secondary outcomes:
measure: eye head coordination
timeFrame: 6 weeks
Other outcomes:
measure: saccadic eye movement
timeFrame: 6 weeks
Locations:
city: Cairo
country: Egypt
facility: Misr university for science and technology
Study officials:
affiliation: Misr University for Science and Technology
name: Samah M Sheha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Accardo AL, Finnegan EG, Kuder SJ, Bomgardner EM. Writing Interventions for Individuals with Autism Spectrum Disorder: A Research Synthesis. J Autism Dev Disord. 2020 Jun;50(6):1988-2006. doi: 10.1007/s10803-019-03955-9.
Clinical trial NCT01398293: A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
Official title: A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, 18 - 60 years of age
* Female subjects must be surgically sterile or post-menopausal
* Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
* Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)

Exclusion Criteria:

* History or evidence of any clinically significant disease or disorder
* Pregnant or lactating women
* Male partners of women who are lactating or trying to become pregnant
* Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
* Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug, biologic, or device study within three months before first study drug administration

Primary outcomes:
measure: Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose
timeFrame: approximately 9 weeks
Secondary outcomes:
measure: Pharmacokinetics: Plasma concentrations
timeFrame: approximately 9 weeks
measure: Safety: Incidence of adverse events
timeFrame: approximately 9 weeks
measure: Cardiac response: Electrocardiogram (ECG)
timeFrame: approximately 9 weeks
measure: Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes
timeFrame: approximately 9 weeks
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01489293: Inhibitory Receptors in Eosinophils of Atopic Subjects
Official title: Characterization of the Expression and Activity of Inhibitory Receptors Such as CLM-1 in Eosinophils of Atopic Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopy
Atopic Dermatitis
Asthma
Allergic Rhinitis
Food Allergy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: allergy clinic

Brief summary: The purpose of this study is to analyze the expression and activity of inhibitory molecules on eosinophils obtained from allergic subjects.


Eligibility criteria: Inclusion Criteria:

* age 20-60 years
* a physician-diagnosed atopic disease

Exclusion Criteria:

* atopic disease not active
* steroid treatment
* active non-atopic inflammatory disease, including infections
* pregnancy

Primary outcomes:
measure: Expression of surface molecules on eosinophils as assessed by flow cytometry
timeFrame: December 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center. Unit of Allergy and Clinical Immunology
Study officials:
affiliation: Meir Medical Center
name: Alon Y Hershko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731871: Parameters of Lung Maturity During Late Pregnancy
Official title: The Different Factors Involved in Fetal Maturity in Late Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-11-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant ladies from 28 weeks till term

Brief summary: - Lung maturity is one of the most important factors in perinatal medicine

Detailed description: * Fetal development passes in many stages till fetal maturation occurs
* We are trying to line out fetal maturation

Eligibility criteria: Inclusion Criteria:

* pregnant ladies from 28 weeks till term

Exclusion Criteria:

* pregnant ladies before 28 weeks

Primary outcomes:
measure: The number of fetuses who will be mature postnatally
timeFrame: within 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05840471: Tranexamic Acid as an Intervention in Abruptio Placenta
Official title: Tranexamic Acid in Pregnant Women With Abruptio Placenta: A Double-blind, Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Bleeding
Prolonged Pregnancy
Keywords: Abruptio placenta
Interventional study
Perinatal mortality
vaginal bleeding
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization for both groups will be done using the Randomization Allocation Software program. Blindness in each group will be confirmed by a pharmacist who is not involved in the study and will have the codes belonging to the type of intervention with him until the end of the research.

Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Primary purpose: TREATMENT

Brief summary: Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality

Detailed description: Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.

Eligibility criteria: Inclusion Criteria:

* 24 weeks gestation and more
* Stable hemodynamically
* Accepted to participate

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* Defective color vision
* History of venous thromboembolism
* Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease)
* Smoker
* Refused to participate in the trial

Primary outcomes:
measure: Vaginal blood loss
timeFrame: Up to time of delivery
measure: Gestational age
timeFrame: Up to time of delivery
measure: Favorable perinatal outcome
timeFrame: 7 days post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Shahla Kareem Alalaf
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: SHAHLA ALALAF, prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652193: The Effect of Obesity on Recovery Profile in Children
Official title: Does Obesity Effect the Recovery Profile in Children?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic discontinuation and LMA removal), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge will be also noted.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II
* Routine surgery under general anesthesia

Exclusion Criteria:

* Any known cerebrovascular disease
* Long- or short-term (within the previous 24 hours) intake of any drug acting in the central nervous system
* The patients bypassing the recovery room

Primary outcomes:
measure: Time to spontaneous ventilation
timeFrame: up to 20 minutes
measure: LMA removal time
timeFrame: up to 25 minutes
measure: Time to open eyes
timeFrame: up to 30 minutes
measure: PACU discharge time
timeFrame: up to 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty Hospital
Study officials:
References:
Clinical trial NCT02491593: Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
Official title: Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: fecal occult blood
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred from primary care for investigation of symptoms potentially caused by colorectal cancer

Brief summary: The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.

Detailed description: Consecutive patients referred from primary care for colonoscopy due to symptoms are eligible. Patients will receive written information of the study together with the time for colonoscopy. A specific research nurse will call them and for those accepting participation, history and current medication will be collected. Kits will be sent to patients and they will provide three faecal samples before examination. These will be analysed at one certified laboratory.

Hemoglobin concentration will be notified in the range of 50 - \< 1000 ng/mL, or as a negative outcome.

Macroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.

Eligibility criteria: Inclusion Criteria:

* Symptoms associated with colorectal cancer (anemia, change of bowel habits, diarrhoea, constipation, haematochezia, weight loss, anorexia)

Exclusion Criteria:

* Screening investigations
* High-risk patients

Primary outcomes:
measure: Number of patients with high fecal blood output in relation to colorectal cancer
timeFrame: Up to 36 months
Secondary outcomes:
measure: Number of patients with low fecal blood output in relation to colorectal polyps
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Unit of Endoscopy
Study officials:
affiliation: Centre for Clinical research, Eskilstuna, Uppsala universitet
name: Louise Olsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsapournas G, Hellstrom PM, Cao Y, Olsson LI. Diagnostic accuracy of a quantitative faecal immunochemical test vs. symptoms suspected for colorectal cancer in patients referred for colonoscopy. Scand J Gastroenterol. 2020 Feb;55(2):184-192. doi: 10.1080/00365521.2019.1708965. Epub 2020 Jan 6.
Clinical trial NCT00163371: Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
Official title: Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Child
Fluticasone propionate
HPA-axis
Pediatric
Linear growth rate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
* Prepubertal stage
* Good health with the exception of asthma
* History of asthma for at least 6 months
* Currently using rescue medication only

Main Exclusion Criteria:

* Childbearing potential (beyond menarche)
* Concurrent diseases or conditions which may subsequently affect growth
* COPD or relevant lung diseases causing alternating impairment in lung function
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* History of life-threatening asthma
* Current smoking

Primary outcomes:
measure: growth velocity of the right lower leg as measured by knemometry.
Secondary outcomes:
measure: HPA-axis function
measure: weight and height
measure: lung function from spirometry
measure: asthma symptom score, use of rescue medication from diary
measure: adverse events
measure: vital signs, including blood pressure, pulse rate
measure: physical examination
measure: laboratory investigation.
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT01810471: External Ankle Supports - 3D Motion Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ankle Instability
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means of different tests. The dynamic postural control is quantified. The hypothesis was that the devices would stabilize differently the foot segments.


Eligibility criteria: Inclusion Criteria:

* chronic ankle instability
* "giving way"
* repeated ankle sprains

Exclusion Criteria:

* other injuries of the lower extremities
* surgery on the lower extremities

Primary outcomes:
measure: change of the range of motion of the subtalar inversion/eversion in degree
timeFrame: baseline (=before) and immediately after applying the device
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital
Study officials:
affiliation: Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury
name: Benita Kuni, Dr. med., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuni B, Mussler J, Kalkum E, Schmitt H, Wolf SI. Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in healthy subjects and subjects with chronic ankle instability. Physiotherapy. 2016 Sep;102(3):287-93. doi: 10.1016/j.physio.2015.07.004. Epub 2015 Sep 3.
Clinical trial NCT06135493: Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
Official title: Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Neuropathy Due to Chemotherapy
Keywords: Paclitaxel
Breast Cancer
Peripheral Neuropathy
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect.

The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.


Eligibility criteria: Inclusion Criteria:

* Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.

Exclusion Criteria:

* Known hypersensitivity to Losartan.
* Not Known Hypertensive patients
* Not Known Diabetic patients
* Treatment with Losartan/ARBs/ACE-I prior to the study.
* Previous neuropathy
* Renal impairment (Serum creatinine \> 2 mg/dl)
* Significant liver disease: liver enzymes 2 folds the upper normal limit
* Metastatic breast cancer
* Pregnancy or lactation
* Taking other medication for neuropathic pain
* Significant Hypotension

Primary outcomes:
measure: Development of paclitaxel-induced peripheral neuropathy
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient QOL
timeFrame: 12 weeks
measure: Pain Severity
timeFrame: 12 Weeks
measure: Serum biomarker
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University
Study officials:
References: