louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00476671: Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1
Official title: Prevalence and Risk Factors of HIV-associated Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1 Infected Thai Individuals With Undetectable Viral Load in the HAART Era.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: neuropsychiatric
neurocognitive
psychiatric
HIV related dementia
MCMD
HIV-1
Prevalence, risk factors of neurocognitive impairment and psychiatric comorbidities in HIV-1 infected patients with undetectable viral load in the HAART era.
Treatment Experienced
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: University of Hawaii
name: SEARCH Research Foundation
name: Chulalongkorn University
name: University of Missouri, Department of Psychology, Division of Neuroscience
First posted: 2007-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected adults with viral \< 50 copies/ml on NNRTI based HAART

Brief summary: To assess the prevalence and risk factors of neurocognitive impairment and psychiatric comorbidities in HIV infected patients who have undetectable viral load, have been on HAART for at least 1 year and have no history of CNS infection.

Detailed description: To understand how to prevent and treat HIV-associated neurocognitive impairment and psychiatric comorbidities in HIV-infected Thai individuals who don't have current AIDS related illness or current and prior central nervous system (CNS) infection, and have been well treated with HAART with undetectable HIV RNA.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Evidence of HIV infection (confirmed positive ELISA and documented history of measurable HIV RNA)
* Age \> 18 years old
* Plasma HIV RNA of \< 50 copies/ml within 3 months prior to screening
* Have been on only NNRTI-based HAART regimen for the entire duration and for at least1 year.

Exclusion Criteria:

* Current AIDS defining illnesses
* Current or history of previous CNS infection.
* Head injury with loss of consciousness greater than 1 hour
* Acute illness within 30 days prior to entry that, in the opinion of investigators, would prevent patients from completing the protocol required procedures.
* Known learning disability including dyslexia

Primary outcomes:
measure: Neuropsychological testing score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Jintanat Ananworanich, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05035771: The IMPACT PAD Study
Official title: A Safety and Feasibility Study of Intraprocedural Physiology Measurements During Peripheral Endovascular Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 20
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: Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Detailed description: Endovascular treatment for peripheral arterial disease is commonly performed for claudication or critical limb threatening ischaemia (ischaemic rest pain, foot ulcer or gangrene). Disease is generally identified using Ankle Brachial Pressure Index or Toe Brachial Pressure Index and then lesions delineated using Doppler ultrasound or CT angiography. Clinical severity is staged using absolute walking distance (metres) in claudicants or the Society for Vascular Surgery wIfI (wound, ischaemia, foot infection) score in critical limb threatening ischaemia patients.

Intra-procedural lesion assessment and quality control is currently performed anatomically using angiography alone, with a few centres using pullback pressures across a lesion to give supplementary trans-lesional gradients or intravascular ultrasound (IVUS) to give pre and post intervention diameter and vessel area measurements. No direct or quantitative assessment of flow, or pressure normalisation across lesions is currently performed during interventions to improve blood flow to the leg.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Peripheral arterial stenosis scheduled for endovascular treatment

Exclusion Criteria:

* \< 18 year of age
* Unable to give informed consent
* Estimated GFR ≤30 mL/min
* Dialysis dependent
* Unable to receive antiplatelets or periprocedural anticoagulation
* Pregnancy or breastfeeding
* Contraindication to adenosine (severe asthma or COPD)
* WIfI ulcer score \<2 (no exposed bone)
* WIfI infection score \<2 (skin and subcutaneous tissues only)
* WIfI gangrene score \<3 (limited to digits)
* COVID-19 positive
* NYHA IV heart failure
* Contra-indication to adenosine including arrhythmia, asthma or allergy

Primary outcomes:
measure: Pressure wire measurements
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre
state: Essex
Study officials:
affiliation: Mid and South Essex NHS Foundation Trust
name: Ankur Thapar, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03302871: Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A
Official title: Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Palsy
Keywords: cerebral palsy
botulinum toxin A
constraint induced movement therapy
transcranial direct current stimulation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.

In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.

Detailed description: Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.

Eligibility criteria: Inclusion Criteria:

* diagnosis of unilateral cerebral palsy
* able to activate wrist and finger extensors
* being scheduled for BoNT-A treatment for upper limb

Exclusion Criteria:

* significant loss of wrist and or fingers
* history of orthopedic surgery to plegic upper limb

Primary outcomes:
measure: Assisting Hand Assesment
timeFrame: 6 weeks
Secondary outcomes:
measure: Jebsen Taylor Hand Function Test
timeFrame: 6 weeks
Other outcomes:
measure: Modifed Ashworth Scale
timeFrame: 6 weeks
measure: Active ROM of wrist dorsiflexion
timeFrame: 6 weeks
measure: Modified Tardieu Scale
timeFrame: 6 weeks
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Nigar Dursun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02577471: The Function of Gastrointestinal Tract During Pregnancy
Official title: The Function of Gastrointestinal Tract During Pregnancy and After Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: Constipation
pregnancy
delivery
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400 pregnant ladies, 400 ladies who had delivered within three weeks and 200 control ladies who were not pregnant

Brief summary: In this prospective study the function of gastrointestinal tract was assessed using constipation questionnaire (Rome criteria and bowel function index).


Eligibility criteria: Inclusion Criteria:

* informed consent obtained
* pregnancy, delivery
* female non pregnant

Exclusion Criteria:

* no informed consent
* male

Primary outcomes:
measure: Bowel function
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern savo
Study officials:
References:
Clinical trial NCT01424371: Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)
Official title: A Case-Control Study to Evaluate the Effectiveness of Adjuvanted Trivalent Inactivated Influenza Vaccine in the Elderly Aged ≥65 Years.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-08-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All elderly over 65 years in the lower mainland of British Columbia presenting with an influenza-like-illness

Brief summary: This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the elderly will produce greater vaccine effectiveness in their group.

Detailed description: To evaluate the effectiveness of adjuvanted trivalent inactivated influenza vaccine in the elderly (aged ≥ 65 years) through the reduction in relative risk of microbiologically confirmed influenza illness

Eligibility criteria: Inclusion Criteria:

1.Elderly tested for influenza as part of routine clinical care in the Lower Mainland and on Vancouver Island during the influenza season.

Cases: Proven influenza diagnosed on naso-pharyngeal swab via PCR Controls: Elderly with influenza-like-illness testing negative for influenza during the influenza season.

Exclusion Criteria:

1. Known immunodeficiency disorders (including HIV)
2. Current or recent (within 90 days prior to first dose of influenza vaccine) immunosuppressive treatment including chronic oral steroids (1mg/kg for \> 4 weeks), cytotoxic chemotherapy, radiation therapy, other immunosuppressive drug and biologic agents Note: Use of topical or inhalant corticosteroids is acceptable.
3. Administration of immunoglobulins during the study period;

Primary outcomes:
measure: Vaccine effectiveness against laboratory confirmed influenza illness
timeFrame: Influenza season 2011/12 and 2012/13
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Fraser Health Authority
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: PAUL G VAN BUYNDER, MBBS MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02879071: Long Term Follow-up After Embolization of Brain Arteriovenous Malformations
Official title: Long Term Follow-up After Embolization of Brain Arteriovenous Malformations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arteriovenous Malformations
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing embolization for an arteriovenous malformation

Brief summary: The time-frame and the follow-up elements after embolization of brain arteriovenous malformations are not standardized. Therefore, few reliable follow-up data are available for these patients. This study aims at collecting standardized long term data for these patients.


Eligibility criteria: Inclusion Criteria:

* arteriovenous malformation
* age \> 18 years old

Exclusion Criteria:

* none

Primary outcomes:
measure: angiographic evaluation of the arteriovenous malformation occlusion
timeFrame: 5 years after embolization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
citation: Baharvahdat H, Blanc R, Fahed R, Pooyan A, Mowla A, Escalard S, Delvoye F, Desilles JP, Redjem H, Ciccio G, Smajda S, Hamdani M, Mazighi M, Piotin M. Endovascular treatment as the main approach for Spetzler-Martin grade III brain arteriovenous malformations. J Neurointerv Surg. 2021 Mar;13(3):241-246. doi: 10.1136/neurintsurg-2020-016450. Epub 2020 Sep 28.
citation: Baharvahdat H, Blanc R, Fahed R, Smajda S, Ciccio G, Desilles JP, Redjem H, Escalard S, Mazighi M, Chauvet D, Robert T, Sasannejad P, Piotin M. Endovascular Treatment for Low-Grade (Spetzler-Martin I-II) Brain Arteriovenous Malformations. AJNR Am J Neuroradiol. 2019 Apr;40(4):668-672. doi: 10.3174/ajnr.A5988. Epub 2019 Feb 21.
Clinical trial NCT05581771: Factors Associated With Success of NIPPV in ALS Patients
Official title: Factors Associated With Success of Non-invasive Positive Pressure Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALS
Keywords: Noninvasive positive pressure ventilation
Amyotrophic lateral sclerosis
Adherence
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS patients who were admitted for applying non-invasive positive pressure ventilation initially.

Brief summary: This is a retrospective cohort study to assess the factor associated with success of non-invasive positive ventilation in ALS patients.

Detailed description: Patients with ALS who were admitted to a tertiary hospital for initially applying non-invasive positive pressure ventilation (NIPPV). The objective of this study was to investigate factors associated with optimal NIPPV initiation and adherence, and to assess the long-term effects of NIPPV adherence in ALS patients.

Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the El Escorial World Federation criteria for probable, or definite ALS
* Aged ≥ 19 years
* Patients who performed blood gas analysis including venous blood gas and arterial blood gas before NIPPV application.

Exclusion Criteria:

* Patients who had experience in applying the NIPPV or currently using NIPPV
* Patients who applied in outpatient settings
* Patients who did not perform blood gas analysis before NIPPV application
* Patietns who had a history of asthma or COPD,
* Patients who didn't have any record of NIPPV application time

Primary outcomes:
measure: Success of NIPPV
timeFrame: through intervention completion, with an average of 10 days
Secondary outcomes:
measure: Lenght of stay
timeFrame: through intervention completion, with an average of 10 days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
name: Jaewon Beom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06330571: The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial.
Official title: The Accuracy of Clear Aligners in Maxillary Molar Distalization With and Without Attachments: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontic Aligners
Keywords: Orthodontic, aligner, molar
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.


Eligibility criteria: Inclusion Criteria:

1. Age more than15 years.
2. Gender; male or female.
3. Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
4. Mild crowding in the upper arch (≤ 4 mm).
5. Absence or previous extraction of the upper third molars.
6. Good compliance during the treatment

Exclusion Criteria:

1. Transversal dental or skeletal discrepancies.
2. Extraction treatment (except for the third molar).
3. Periodontal disease. .
4. Prosthodontics rehabilitation of the maxillary molars.

Primary outcomes:
measure: Efficiency of aligners in molar distalization
timeFrame: 6 months
Secondary outcomes:
measure: Amount of anchorage loss
timeFrame: 6 months
measure: Amount of molar tipping
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university
Study officials:
affiliation: Ain Shams University
name: Noha E Sabet, Prof
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Marwa s Abdelatef, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01798771: Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Official title: Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Malignant Neoplasm of Nervous System
Glioma
Glioblastoma
Metastasis
Keywords: primary brain tumor
malignant glioma
intraoperative MRI
5-ALA
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.


Eligibility criteria: Inclusion Criteria:

* adult patient (\> 18 years) able to give informed consent
* primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
* tumor must be deemed completely resectable by neurosurgeon
* diagnostic MRI

Exclusion Criteria:

* patient unable or unwilling to give informed consent
* infratentorial tumor location
* tumor location in or near eloquent areas
* multifocal tumor
* existance of contraindications to undergo MRI examination
* previous surgical treatment for an intraaxial brain tumor

Primary outcomes:
measure: Extent of Resection
timeFrame: Early postoperative MRI within 72 hrs
Secondary outcomes:
measure: Volumetric extent of resection
timeFrame: Early postoperative MRI within 72hrs
measure: PFS 6
timeFrame: 6 months following surgery
measure: PFS 12
timeFrame: 12 months following surgery
measure: Quality of life
timeFrame: 6 months/12 months
Other outcomes:
measure: NIHSS
timeFrame: 5 days following surgery
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinik für Neurochirurgie Johann Wolfgang Goethe University
state: Hessen
Study officials:
affiliation: Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
name: Christian Senft, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01260571: Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)
Official title: Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Treatment of Acne Vulgaris Grade II in a Short Period of Time.
Keywords: blackheads and pimples
Acne vulgaris grade II
Lead sponsor: Zurita Laboratorio Farmaceutico Ltda.
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sixty two subjects will take part in this study. The study is unic arm. The subjects used the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24 hours after application.

A follow-up visit will be made 24 hours after initiation of treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects of both sexes aged to 12 years to 35 years
* Oily skin prone to acne
* Presence of at least three inflammatory lesions, diagnosed as grade II acne vulgaris.
* Sign the informed Consent Form
* Comply the requirements and attend to study visits

Exclusion Criteria:

* Pregnancy (need for urinary pregnancy test for women of childbearing age)
* Lactation
* Presence of acne conglobata and nodulocystic
* Pathologies associated hormonal (thyroid diseases, ovaries micropolycystic)
* Drug use systemic corticosteroids, anticonvulsants and / or new drugs for up to one month before to selection.
* History of atopy or allergic cutaneous
* History of hypersensitivity to benzoyl peroxide and sulfur
* Beginning or ending the use of contraceptives (for females)
* Intense sun exposure until one month before the evaluation

Primary outcomes:
measure: Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples).
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele
state: São Paulo
Study officials:
References: