louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06282289: Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
Official title: Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Speech
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut de l'Audition
First posted: 2024-02-28
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to investigate the preferential responses of speech neural systems in infants.

The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).

Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz.


Eligibility criteria: Inclusion Criteria:

* be 6 or 10 months old (+/- 2 weeks)
* have received age-appropriate information on the experiment
* their legal guardians have received appropriate information and given their oral consent.

Exclusion Criteria:

* A neurological disorder (visual, auditory, motor, executive)
* Developmental delay

Primary outcomes:
measure: Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age.
timeFrame: at 10-months, 6-months and 18-months of age
Secondary outcomes:
measure: The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs
timeFrame: at 10- and 6-months of age
measure: The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs
timeFrame: at 10- and 6-months of age
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03417089: Suspension of Falciform Ligament During Mini Gastric Bypass
Official title: Suspension of Falciform Ligament During Mini Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper GIT Surgery
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension

Detailed description: The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension

Eligibility criteria: Inclusion Criteria:

* Morbidly obese patient with BMI more than 40 with or without co-morbidity
* Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria:

* Unfit patients for laparoscopic sleeve gastrectomy
* Patients refuse to share in the study
* Patients that already on PPI due to any indications
* Revisional surgery for obesity
* Previous upper abdominal surgery

Primary outcomes:
measure: the difficulty of working during mini gastric bypass
timeFrame: 5 hours
Secondary outcomes:
measure: operative time
timeFrame: 6 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Minia University
name: Alaa M Sewefy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860989: A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Official title: An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cure Rate
Keywords: parasitemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

Detailed description: the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.

cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 20 to 60 years
* Presence of mono-infection of P. falciparum
* Weight between 40 kg to 90 kg

Exclusion Criteria:

* Patients with signs and symptoms of severe/complicated malaria
* Mixed Plasmodium infection
* Presence of other serious or chronic clinical condition requiring hospitalization.
* Severe malnutrition
* Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Primary outcomes:
measure: 28-day Cure Rate
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchabari
country: Thailand
facility: Novartis Investigative Site
city: Srisaket
country: Thailand
facility: Novartis Investigative Site
city: Tak
country: Thailand
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05467189: Antineoplastic Drugs in Elderly Patients
Official title: Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Population Pharmacokinetics
Effectiveness
Safety
Antineoplastic Drugs
Elderly Patients
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
name: The Second Hospital of Shandong University
name: The Affiliated Hospital of Qingdao University
First posted: 2022-07-20
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with cancer (≥65years)

Brief summary: The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be enrolled in the study:

1. Age ≥65 years old;
2. Diagnosed with cancer;
3. Using antineoplastic drugs for treatment.

Exclusion Criteria:

Subjects with any of the following criteria will not be enrolled in this study:

1. Patients who are expected to die within 48 hours;
2. Patients with allergy to antineoplastic drugs;
3. Patients receiving other investigational drugs;
4. Other factors that the researcher considers unsuitable for inclusion.

Primary outcomes:
measure: The peak plasma drug concentration of antineoplastic drugs.
timeFrame: at (0-4) hours after administration
measure: The random plasma drug concentration of antineoplastic drugs.
timeFrame: at (4-10) hours after administration
measure: The trough plasma drug concentration of antineoplastic drugs.
timeFrame: at (1-2) hours before the next administration
Secondary outcomes:
measure: Objective ResponseRate ,ORR
timeFrame: Enrollment to end of treatment up to 5 years
measure: Overall Survival ,OS
timeFrame: First day of study treatment to the date of death due to any cause, assessed up to 5 years
measure: Progression-free Survival ,PFS
timeFrame: First day of study treatment to the date of disease progression or death due to any cause, assessed up to 5 years
measure: Time to Progression ,TTP
timeFrame: Enrollment to end of treatment up to 5 years
measure: The incidence of adverse drug reaction
timeFrame: Enrollment to end of treatment up to 5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Zhao Wei, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT04013789: Comparison of Two Daily Disposable Lenses
Official title: Comparison of Two Daily Disposable Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Myopia
Keywords: eye strain
eye fatigue
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Detailed description: Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Eligibility criteria: Inclusion Criteria:

* At least 3 months of soft contact lens wearing experience;
* Wears habitual lenses at least 5 days per week and at least 8 hours per day;
* Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
* Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
* Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Routinely sleeps in contact lenses;
* Known pregnancy at time of enrollment;
* Binocular vision issues or issues of eye alignment;
* Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
* Use of medications as specified in the protocol;
* Ocular surgery within the past 12 months;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Distance Visual Acuity (VA) With Study Lenses
timeFrame: Week 1, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Indiana
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Project Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT04172389: Treatment of Vesico-vaginal Fistula by a Robot Assisted Laparoscopy : Results of a Multicentric Series (FFVLARO)
Official title: Multicentric Retrospective Evaluation of the Vesico-vaginal Fistula Repair by Robot Assisted Laparoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vesico-vaginal Fistula
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a robotic vesico-vaginal fistula repair

Brief summary: Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.


Eligibility criteria: Inclusion Criteria:

* presence of a vesico-vaginal fistula

Exclusion Criteria:

-

Primary outcomes:
measure: Presence of urinary leakage through the vagina post surgery after the removal of the urinary tube
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: centralHNF
state: Grand EST
Study officials:
affiliation: Central Hospital, Nancy, France
name: pierre lecoanet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03937089: Analysis of Endocavitary Electrical Signal and Surface Electrocardiogram to Predict Ablation Outcome in Persistent Atrial Fibrillation
Official title: Analysis of the Endocavitary Electrical Signal and Surface Electrocardiogram to Determine Relevant Features for an Accurate Prediction of Ablation Outcome for Patients in Persistent Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent AF, who underwent a CA procedure in the Nancy hospital between January 2011 and April 2017, will be included in this retrospective study.

Brief summary: Background :

Despite recent progress in the management of patients with Atrial Fibrillation (AF), AF remains one of the main risk factor of stroke, heart failure and cardiovascular mortality in the world. AF is the most common cardiac arrhythmia, and its prevalence is expected to grow in the coming years.

Catheter ablation (CA) of AF can be successful in restoring and maintaining Sinus rhythm (SR) in patients with paroxysmal, and persistent AF. Haissaguerre et al. have shown that AF ablation of the heart by isolating the Pulmonary Vein is usually sufficient. However, when ablating persistent AF patients ablating pathological regions in the atria is also required. CA is still a challenging procedure, and reported success rate for persistent AF patients remains relatively low (around 60%). This procedure is associated with risks inherent to any invasive cardiac procedures.

A better identification of good responders would reduce the risks associated with ablation, especially for patients with low odds of favorable outcome, while also increasing the success rate of the procedure. It has been shown in the literature the long-term CA outcome can be predicted non-invasively by atrial fibrillatory wave (f-wave) amplitudes.

Hypothesis :

We assume that a morphological analysis of the f-waves on standard twelve ECG will allow for a better CA outcome prediction.

Objectives :

The aim of this study is to automatically analyse the morphology of the ECG signal before a CA procedure, extract relevant features for an accurate prediction of long-term CA outcome for patients in persistent AF.


Eligibility criteria: Inclusion Criteria:

* Patients for which clinical data, along with the ECG signals before and during the CA procedure are available,
* Patients who underwent a first ablation procedure for persistent AF

Exclusion Criteria:

* ECG data is not interpretable
* Patients who underwent a second or umpteenth ablation procedure for persistent AF

Primary outcomes:
measure: Analysis of the f-waves on ECG
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT03621189: The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder
Official title: The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator would like to investigate the impact of theta-burst stimulation over posterior superior temporal sulcus in children and adolescents with autism spectrum disorder


Eligibility criteria: Inclusion Criteria:

* autism spectrum disorder, confirmed by ADOS

Exclusion Criteria:

* current and past systemic disease
* current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
* current and past brain injuries
* intelligence \< 70
* seizure history
* pregnant

Primary outcomes:
measure: Changes of Total Scores of Social Responsiveness Scale
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes of Total Scores of Repetitive Behavior Scale-Revised
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary outcomes:
measure: Changes in Accuracy of Frith-Happe Animation
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes in Accuracy of Eyes Task
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Functional MRI (Biological Motion Task)
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
measure: Resting State fMRI
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
measure: Diffusion Tensor Imaging
timeFrame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT03220789: Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group C ) A Randomized Controlled Clinical Trial
Official title: Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: 20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)

* for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
* In the study group: implant will be inserted in the low speed osteotomy site.
* In the control group: implants will be inserted in the conventional prepared osteotomy site.
* For both groups there is no surgical guide used.
* The flap will then be copiously irrigated with saline in preparation for closure.
* The flap will then be closed using interrupted 4/0 resorbable sutures.


Eligibility criteria: Inclusion Criteria:

* Patients restoring missing maxillary teeth with implant placement.
* Both sexes.
* Age: 25-45
* Mesio-distal dimensions: Not less than 6 mm
* Bone Height: Not less than 12 mm
* Bucco-lingual dimensions: Not less than 8mm
* All measures will be assessed using CBCT.

Exclusion Criteria:

* Sites needing bone grafting or augmentation.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.

Primary outcomes:
measure: crestal bone loss
timeFrame: 6 months
Secondary outcomes:
measure: patient morbidity after procedure
timeFrame: 1 day
measure: Implant stability value
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: