louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06889233: MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS
Official title: MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: AUTISM
ASD
RAVEN
CARS
BOT2
FINE MOTOR SKILLS
Gross motor skills
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: autistic children age ranged from 5 to 12 years

Brief summary: To investigate the relationship between cognitive function, the severity of autism spectrum disorder (ASD), and the development of fine and gross motor skills in children with ASD

Detailed description: A sample of 64 children with autism aged from 5 to 12 years recruited from centres and schools of special needs for intellectual and developmental disabilities to measure cognitive function using the Raven's Progressive Matrices and measure the severity of autism using the Childhood Autism Rating Scale (CARS). These assessments will then be compared with the children's fine and gross motor abilities

Eligibility criteria: Inclusion criteria:

1. Children had been diagnosed with ASD.
2. Their chronological age ranged from 5 years to 12 years.
3. Intelligence quotient (IQ) ranged from 55 to 85.

Exclusion criteria:

Any child with the following criteria would be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:

1. The child with ASD and other motor disabilities.
2. Visual or hearing impairment.

Primary outcomes:
measure: measuring motor proficiency (gross & fine motor skills ) by using BOT2 scale
timeFrame: 12 weeks
Secondary outcomes:
measure: measuring cognitive functions by RAVEN Progressive matrices
timeFrame: 12 weeks
Other outcomes:
measure: measuring severity of autism by using CARS scale
timeFrame: 12 weeks
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy cairo university
state: Dokki
Study officials:
affiliation: Cairo University
name: Heba Kamal professor, professor of physical therapy
role: STUDY_CHAIR
affiliation: Cairo University
name: Alaa fahmy hassan El Nemer, lecturer of physical therapy
role: STUDY_DIRECTOR
References:
Clinical trial NCT03406533: Sedation Strategies for Diagnostic Bronchoscopy
Official title: The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchoscopy
Sedation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2018-01-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Scheduled for flexible diagnostic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts

Primary outcomes:
measure: Cough score
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
Secondary outcomes:
measure: Body movement
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
measure: Satisfaction score of the patients and bronchoscopists
timeFrame: Across the procedure, assessed up to 2 hours
measure: Amount of the rescue use of propofol
timeFrame: After sedation induction, assessed up to 2 hours
measure: Recovery time
timeFrame: After termination of the sedation medication, assessed up to 2 hours
measure: Prevalence of the side effects of respiratory and circulatory system
timeFrame: Across the sedation duration, assessed up to 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Faculty of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06143033: A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area
Official title: A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Area
Lead sponsor: Dime Beauty Co.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-22
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the efficacy of the DIME Beauty Luminosity Eye Serum in improving the appearance of skin in the periorbital eye area. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 30, and Day 60, photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.


Eligibility criteria: Inclusion Criteria:

* Females age 18-65.
* Have visible dark circles under the eyes.
* Have puffy eyes.
* Have bags under the eyes.
* Have visible fine lines and wrinkles around the eyes.
* Have a smartphone or camera to take before-and-after selfies.

Exclusion Criteria:

* Anyone not in good health.
* Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
* Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
* Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
* Anyone who cannot/ will not commit to the study protocol.
* Anyone with a history of substance abuse.

Primary outcomes:
measure: Change in appearance of periorbital puffiness. [Baseline to Day 60]
timeFrame: 60 days
measure: Change in appearance of dark circles underneath eyes. [Baseline to Day 60]
timeFrame: 60 days
measure: Change in participants' perception of the appearance of periorbital puffiness. [Baseline to Day 60]
timeFrame: 60 days
measure: Change in participants' perception of the appearance of dark circles underneath eyes. [Baseline to Day 60]
timeFrame: 60 days
Secondary outcomes:
measure: Change in appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
timeFrame: 60 days
measure: Change in participants' perception of the appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
timeFrame: 60 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT02362633: Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Official title: Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Chungbuk National University
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the long-term effect of Transcranial Direct Current Stimulation (tDCS) on appetite control related brain regions.

Detailed description: Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a variety of clinical conditions. In addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity.

The investigators aim to assess whether long-term modulation of the dorsolateral prefrontal cortex (DLFPC) using tDCS, modifies behavioral response and brain activity while watching visually presented food cues and taste cues in obese subjects.

Subjects will be randomly divided into sham and real tDCS arms. Subjects will receive sham or real tDCS ten times. Subjects will be investigated before and after sham or real tDCS interventions. Subjects will perform functional MRI experiments with visual and taste food cues. Questionnaire with behavior measures, body compositions, blood tests will be performed.

Eligibility criteria: Inclusion Criteria:

* BMI \> 26 kg/m2

Exclusion Criteria:

* History of brain trauma, epilepsy, or other neurological problems

Primary outcomes:
measure: Regional brain activity measured by blood-oxygen-level dependent (BOLD) signal of functional MRI
timeFrame: Day 14 (After ten interventions)
Secondary outcomes:
measure: Behavior outcomes on the visual analog scale
timeFrame: Day 14 (After ten interventions)
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University
state: Chungcheongbuk-Do
Study officials:
References:
Clinical trial NCT05715333: Study of CM326 Injection in Healthy Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.

Detailed description: The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years and ≤ 65 years, healthy male.
* With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
* Subjects can communicate well with investigators and comply with protocol requirements.

Exclusion Criteria:

* Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
* Major surgery is planned during the study period.
* The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
* Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
* There are any reasons that the investigator believes will prevent the subject from participating in the study.

Primary outcomes:
measure: Emergency adverse events during treatment
timeFrame: Up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
Study officials:
affiliation: Peking University Care Luzhong Hospital
name: Jie Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Care Luzhong Hospital
name: Hong Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01331733: Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
Official title: Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sterility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring SAU
First posted: 2011-04-08
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females affected by sterility able to undergo intrauterine insemination

Brief summary: To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.

Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-36 years
* Body mass index (BMI) between 18 and 26
* Prolactin within the laboratory normal range
* Couples affected by sterility able to treat by IUI (intrauterine insemination)
* Patients undergoing Menopur® treatment
* Normal thyroid function
* Regular menses (21-35 days)
* Couples willing to participate in the study that have signed the informed consent form
* Seminal sample REM\>3 million

Exclusion Criteria:

* Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
* Policystic ovarian syndrome
* Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 30 days
Secondary outcomes:
measure: Live birth rate
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Investigational site
state: Tarragona
city: Barcelona
country: Spain
facility: Investigational site
city: Ciudad Real
country: Spain
facility: Investigational site
city: Gerona
country: Spain
facility: Investigational site
city: La Rioja
country: Spain
facility: Investigational site
city: Navarra
country: Spain
facility: Investigational site
city: Valladolid
country: Spain
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT04326933: Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes
Official title: Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes in Relation to Hematologic Response in Patients With Chronic Phase Chronic Meyloid Leukemia: Assiut University Hospital Insight
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Diagnosed as Chronic Meyloid Leukemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with chronic phase chronic meyloid leukemia.

Brief summary: Determine the effects of tyrosine kinase Inhibitors on liver enzymes and electrolytes in relation to hematologic response in patients with chronic phase chronic meyloid leukemia.. Assiut University Hospital insight..

Detailed description: CML is a myeloproliferative neoplasm with unique biological and clinical features.

CML accounts for 15_20% of newly diagnosed cases of leukemias among adults. CML can present in three clinical phases : chronic phase, accelerated phase and blast phase.

CML is characterized by prodction of a breakpoint cluster region abelson(BCR-ABL) fusion protein with ABL kinase activity. This is due to reciprocal translocation between chromosome 9 and 22.

Imatinib \& Nilotinib, an ABL kinase inhibitors, which has revolutionized the CML therapy, are a selective tyrosine kinase inhibitors.

The aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with CML
* Chronic phase CML
* Normal hepatic and renal functions

Exclusion Criteria:

* Blastic phase CML
* Accelerated phase CML
* Hepatic \& renal impairment

Primary outcomes:
measure: Follow up liver enzymes as AST, ALT, ALP and GGT before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib).
timeFrame: 6 months
measure: Follow up electrolytes as Na, K, Ca and P before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Not affiliated
name: Howaida A Nafady, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671133: Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
Official title: Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide, Attempted
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ED with a psychiatric concern. Our first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. We hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Presentation to emergency psychiatry service

Exclusion Criteria:

* Inability to understand study procedures and provide informed consent, such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication
* Presence of violent or extremely agitated behavior

Primary outcomes:
measure: Suicide attempt
timeFrame: 6-months
Secondary outcomes:
measure: Suicide attempt
timeFrame: 1-month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01457833: Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema
Official title: Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Emphysema
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Detailed description: Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility criteria: Inclusion Criteria:

* pulmonary function: FEV1 \< 45 %, RV \> 150 %, TLC \> 100 %
* heterogeneous emphysema

Exclusion Criteria:

* homogeneous emphysema
* significant bronchiectasis
* severe concomitant diseases
* pregnancy

Primary outcomes:
measure: Improvement in pulmonary function (FEV1 and RV/TLC)
timeFrame: 6 months
Secondary outcomes:
measure: Number of severe adverse events
timeFrame: 6 months
measure: Evaluation of valve migration rate
timeFrame: 6 months
measure: Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
timeFrame: 6 months
measure: Average changes in 6-minute-walk-distance
timeFrame: 6 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
Study officials:
References: