louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04568707: Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)
Official title: Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Neurologic Manifestations
Psychiatric Manifestations
Keywords: COVID-19
neurological disease
Multiple Sclerosis
psychiatric disease
biology,
biocollection,
biomarkers,
DNA,
Parkinson's Disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Paris Brain Institute (ICM)
First posted: 2020-09-29
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.


Eligibility criteria: 1. Age over 18 yo
2. Patient having presented or presenting a Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
3. And patient with:

   1. a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or
   2. either a chronic neurological or psychiatric pathology

Primary outcomes:
measure: dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients
timeFrame: 12 months
Secondary outcomes:
measure: Serum neurofilaments
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
Study officials:
References:
citation: Louapre C, Ibrahim M, Maillart E, Abdi B, Papeix C, Stankoff B, Dubessy AL, Bensa-Koscher C, Creange A, Chamekh Z, Lubetzki C, Marcelin AG, Corvol JC, Pourcher V; COVISEP and Bio-coco-neuroscience study group. Anti-CD20 therapies decrease humoral immune response to SARS-CoV-2 in patients with multiple sclerosis or neuromyelitis optica spectrum disorders. J Neurol Neurosurg Psychiatry. 2022 Jan;93(1):24-31. doi: 10.1136/jnnp-2021-326904. Epub 2021 Aug 2.
Clinical trial NCT00746707: Biologic Glue for First Degree Perineal Tears
Official title: Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grade 1 Perineal Tears
Keywords: adhesive glue, perineal tear, suture
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair

Detailed description: This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.

Eligibility criteria: Inclusion Criteria:

* women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears

Exclusion Criteria:

* excessive bleeding,
* chronic steroid treatment,
* immunosuppressive treatment,
* active infection,
* allergy to Dermabond or Histoacryl

Primary outcomes:
measure: Functional and cosmetic evaluation of perineal tear area.
timeFrame: At least six weeks after birth
Secondary outcomes:
measure: Assessment of pain at least six weeks after delivery
timeFrame: At least six weeks after delivery
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: hadassha medical organization, jerusalem israel
name: yosef ezra, M.D.
role: STUDY_DIRECTOR
References:
citation: Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.
Clinical trial NCT01582607: Subarachnoid Administration of Levobupivacaine for Cesarean Section
Official title: Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stillborn Caesarean Section
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in doses achieving approximately an ED 50.

Detailed description: Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date .

Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed.

Eligibility criteria: Inclusion Criteria:

* Parturients scheduled for elective c section
* Stillborn
* Normal cardiotocogram

Exclusion Criteria:

* BMI\>35kg/m2
* Height \<150cm or \>185cm
* Age (\<18, \>40)
* ASA \> II
* Multiple gestation
* Pregnancy complications (eclampsia, GDP, placenta previa, \>2 previous c section)
* Contraindication to spinal anaesthesia
* Failure to educate the patient, language barrier
* Patient preferred GA

Primary outcomes:
measure: Sensory block
timeFrame: up to 150 minutes average
measure: Motor block
timeFrame: up to 150 minutes
Secondary outcomes:
measure: Hemodynamics profile (arterial pressure. heart rate)
timeFrame: up to 150 minutes average
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras, Department of Anesthesiology
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Nikolaos G Flaris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Kriton S Filos, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06752707: MiGo Tracker Remote Monitoring of Home Exercise After Stroke
Official title: MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subacute Stroke
Keywords: Remote Therapeutic Monitoring
Stroke
Home Exercise Therapy
MiGo Tracker
Lead sponsor: Flint Rehabilitation Devices, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Rancho Research Institute, Inc.
First posted: 2024-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomized controlled trial with individuals with subacute stroke (N=50). Participants will be randomly assigned to either the MiGo Tracker RTM program (intervention group) or prescription of home exercises with no monitoring (usual care/control group). All participants will still receive usual post-stroke care, including outpatient rehabilitation. The main question this study aims to answer is: Does a MiGo Tracker RTM program lead to significantly greater motor recovery at three-months post stroke than the usual care group. If successful, MiGo Tracker will lead to increased home exercise adherence and improved health outcomes for thousands of individuals following stroke.


Eligibility criteria: Inclusion Criteria:

* Experienced one or more strokes less than one month (30 days) prior
* Upper Extremity Fugl-Meyer Score \> 5 and \<= 55 out of 66
* Absence of moderate to severe pain (\<= 4 on the 10 point visual-analog pain scale)

Exclusion Criteria:

* age \<18 years old
* Unable to follow 2-step commands
* Other neurological diagnosis (e.g. Parkinson's Disease)
* Other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

Primary outcomes:
measure: Change in Upper Extremity Fugl-Meyer from Baseline
timeFrame: Baseline and 3 months post stroke
Secondary outcomes:
measure: Change in Action Research Arm Test from Baseline
timeFrame: Baseline and 3 months post stroke
measure: Change in Box and Blocks from Baseline
timeFrame: Baseline and 3 months post stroke
measure: Change in Motor Activity Log from Baseline
timeFrame: Baseline and 3 months post stroke
measure: Change in Modified Ashworth Spasticity Scale from Baseline
timeFrame: Baseline and 3 months post stroke
measure: Change in Visual Analog Pain Scale from Baseline
timeFrame: Baseline and 3 months post stroke
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute, Inc
state: California
Study officials:
References:
Clinical trial NCT01629407: A Study of the Rate of Progression of Glaucoma During a Follow-up Period of Two Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary open angle glaucoma in one or both eyes

Brief summary: This is an epidemiological, non-interventional, prospective study to collect data on glaucoma progression in a routine setting. Patients may receive treatment at the discretion of their physician per local standard of care.


Eligibility criteria: Inclusion Criteria:

* Glaucoma in one or both eyes

Exclusion Criteria:

* Participation in a glaucoma therapeutic clinical trial

Primary outcomes:
measure: Change from Baseline in Visual Field
timeFrame: Baseline, 24 Months
Secondary outcomes:
measure: Change from Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, 24 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00933907: Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal
Official title: Study Title: Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd PH_DESILSTY_FR (Lactic Acid) .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.


Eligibility criteria: Inclusion criteria:

* Phototype Skin I,II, III e IV Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reactive
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: From the treatment start to the end of the study( treatment period 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT01877707: Near Patient Microbial Testing in Cystic Fibrosis
Official title: A Home-based, Rapid and Quantitative Test for Bacterial Respiratory Infections in Patients With Cystic Fibrosis, to Reduce Admissions and Hospital Stay Length and to Improve Healthcare Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2013-06-14
Enrollment: 16
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms.

Detailed description: 1. To determine if longitudinal profiling of sputum from Cystic Fibrosis patients allow accurate prediction of exacerbations in a study of a larger group and can we confirm the 7+ day early warning system works in this larger group.
2. Is one biomarker sufficient to predict exacerbations - what is the accuracy? Are two or more biomarkers required to achieve an accuracy of greater than 95%?
3. Can we now accurately determine how many hospital bed days a home testing/wellness monitoring device would save? What is the business case for healthcare providers to adopt our future test for home use? We estimate a 50% saving. Can this be confirmed?
4. When used in the clinic, how many hospital days would our test save through faster determination of treatment efficacy? What is the business case for adopting our future test as a point of care test on the ward in Cystic Fibrosis centres? Could this be the new revolutionary tool that we anticipate?
5. We forecast a 50% reduction in costs to treat Cystic Fibrosis patients in disease severity bands 2-A to 5. Can we provide evidence for this to support further investment?

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels.
* Chronic infection with Pseudomonas aeruginosa.
* Patients able to produce daily sputum samples.
* Current history of at least two pulmonary infective exacerbations in the past 12 months.
* Able to give written informed consent

Exclusion Criteria:

* Unable to provide written informed consent
* Patients unable to produce daily sputum samples
* Fewer than two infective pulmonary exacerbations in 12 months

Primary outcomes:
measure: Advance warning of an infective exacerbation
timeFrame: one year
Secondary outcomes:
measure: home monitoring of multiple physiological parameters
timeFrame: one year
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Trust
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Andres Floto, MA, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664507: The Effect and Safety of Low Dose Nebulized Epinephrine in Croup
Official title: The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Croup
Epinephrine, Administration, Inhalation
Keywords: croup, dose, epinephrine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Croup is common illness presenting emergency department with dyspnea. The main treatment for croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized L-epinephrine is restricted that the study of comparision between racemic epinephrine and L-epinephrine.

The investigators conducted this study to compare the effectiveness of low dose L-epinephrine with conventional dose L-epinephrine.


Eligibility criteria: Inclusion Criteria:

* croup children between 6 month and 5 years old
* Westley croup score between 3 and 11

Exclusion Criteria:

* underlying lung or heart disase
* contra indication to dexamethasone
* immune deficient state
* preterm birth
* previous intubation or apnea history

Primary outcomes:
measure: the difference of Westley croup score between baseline and 30 minutes after neublized treatment
timeFrame: 30 minutes
Secondary outcomes:
measure: the incidence of use of additional neublized treatment
timeFrame: 30 minutes
measure: Westley croup score
timeFrame: 30, 60, 90, 120, 180, 240 minutes
measure: the side effect of epinephrine
timeFrame: participants will be followed for the duration of ED stay
measure: respiratory rate, oxygen saturation
timeFrame: 30, 60, 90, 120, 180, 240 minutes
measure: health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom
timeFrame: within 7 days
measure: treatment failure
timeFrame: 30min after 2nd epinephrine nebulizer
measure: rebound effect
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee JH, Jung JY, Lee HJ, Kim DK, Kwak YH, Chang I, Kwon H, Choi YJ, Park JW, Paek SH, Cho JH. Efficacy of low-dose nebulized epinephrine as treatment for croup: A randomized, placebo-controlled, double-blind trial. Am J Emerg Med. 2019 Dec;37(12):2171-2176. doi: 10.1016/j.ajem.2019.03.012. Epub 2019 Mar 8.
Clinical trial NCT00452907: ACT MALI: Treatment of Malaria Based on Combination Therapies
Official title: Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 780
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia


Eligibility criteria: Inclusion Criteria:

* Body weight \> 5kg
* Residence in the investigator site area for the duration of the trial
* Axillary temperature ≥ 37,5°C at Day 0
* Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood

Exclusion Criteria:

* Danger signs or signs of severe malaria
* Other severe illnesses
* Allergy to one of the drugs
* Pregnant women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Clinical and parasitological cure rate
timeFrame: at day 28
measure: Clinical and biological tolerability
timeFrame: During the study period
Secondary outcomes:
Other outcomes:
Locations:
city: Bougoula
country: Mali
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Valérie Lameyre
role: STUDY_DIRECTOR
References:
Clinical trial NCT01547507: Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
Official title: Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Tube
Mechanical Ventilation
Keywords: hemodynamics
respiratory
Lead sponsor: Biovo Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes:

1. AirWay Medix Closed Suction System
2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).


Eligibility criteria: Inclusion Criteria:

1. Aged greater than 18 years
2. Mechanically ventilated for more than 6 hours
3. Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
4. Signed informed consent
5. Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -

Exclusion Criteria:

1. Gross / massive hemoptysis
2. Received lung transplantation in the past
3. Admitted from other hospital already mechanically ventilated
4. Previously received mechanical ventilation
5. Active bronchial bleeding
6. Pregnant women, women who plan to become pregnant and breastfeeding women.
7. Substance or alcohol abuse
8. Participation in concurrent trials
9. Any reasons making the patient a poor candidate in the opinion of the investigator -

Primary outcomes:
measure: hemodynamic and respiratory data
timeFrame: Patients will be followed until extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplaan MC
Study officials:
affiliation: Kaplan Medical Center
name: Nimrod Adi, MD
role: PRINCIPAL_INVESTIGATOR
References: