louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05145530: Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease
Official title: Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Selective Nerve Root Block
Selective Discectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Disc degeneration is a natural part of growing older. Up to 60% of asymptomatic people have MRI findings that are positive. As a result, MRI only provides morphological information and may not be able to determine the clinical significance of the findings.

Detailed description: Many authors believe that patients who suffer from cervical radiculopathy as a result of degenerative disease and have multilevel pathology on imaging studies still have moderate surgical outcomes. This occurs due to a misdiagnosis or the need to perform surgery on multiple levels despite a single painful lesion.

Although the complication rate for 1- and 2-level ACDF is so low that it is considered one of the safest procedures in spine surgery. There is concern that increasing levels of fusion will lead to more complications, such as a higher incidence of persistent axial neck pain, dysphagia, and vertebral artery injury, as well as more postoperative pain and higher narcotic dosages.

Eligibility criteria: Inclusion Criteria:

* all patients presented with unilateral brachialgia due to multilevel cervical disc disease

Exclusion Criteria:

* multilevel cervical disc disease who had bilateral brachialgia,
* myelopathy, double crush syndrome,
* ossified posterior longitudinal ligament (OPLL),
* combined anterior and posterior pathology requiring posterior decompression

Primary outcomes:
measure: pain intensity
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
citation: Kreitz TM, Hollern DA, Padegimas EM, Schroeder GD, Kepler CK, Vaccaro AR, Hilibrand AS. Clinical Outcomes After Four-Level Anterior Cervical Discectomy and Fusion. Global Spine J. 2018 Dec;8(8):776-783. doi: 10.1177/2192568218770763. Epub 2018 Apr 24.
citation: McClure JJ, Desai BD, Shabo LM, Buell TJ, Yen CP, Smith JS, Shaffrey CI, Shaffrey ME, Buchholz AL. A single-center retrospective analysis of 3- or 4-level anterior cervical discectomy and fusion: surgical outcomes in 66 patients. J Neurosurg Spine. 2020 Oct 9;34(1):45-51. doi: 10.3171/2020.6.SPINE20171. Print 2021 Jan 1.
citation: Ross DA, Ross MN. Diagnosis and Treatment of C4 Radiculopathy. Spine (Phila Pa 1976). 2016 Dec 1;41(23):1790-1794. doi: 10.1097/BRS.0000000000001620.
Clinical trial NCT02158130: Effects of Aerobic Exercise Detraining
Official title: Effects of Aerobic Exercise Detraining on Energy Balance in Overweight Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Activity
Body Weight
Obesity
Keywords: Physical Inactivity
Aerobic Exercise Detraining
Body Weight
Energy Expenditure
Metabolic Syndrome
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants that successfully enrolled and completed the E-Mechanic study and are not past 88 weeks study randomization.

Brief summary: The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.

Detailed description: Eligibility criteria include having successfully completed the main E-Mechanic study, be willing to archive blood samples and not being currently enrolled in another study that may effect body, energy intake or energy expenditure. The investigators will measure body weight, waist/hip circumference, blood pressure, body composition, physical activity, questionnaire about appetite/food intake and physical fitness.

Eligibility criteria: Inclusion Criteria:

* Completed the E-Mechanic study
* Be willing to archive blood samples
* Not participating in a study that would alter body weight, energy intake, or energy expenditure.

Primary outcomes:
measure: Body Weight
timeFrame: Week 64 - 88 post study randomization
Secondary outcomes:
measure: Energy Expenditure
timeFrame: Week 64 - 90 since study randomization
measure: Energy Intake
timeFrame: Week 64 - 90 post study randomization
Other outcomes:
measure: Circumferences
timeFrame: Week 64-88 post study randomization
measure: Blood Pressure
timeFrame: Week 64-88 post study randomization
measure: Body Composition
timeFrame: Week 64 - 88 post study randomization
measure: Triglycerides
timeFrame: Week 64 - 88 post study randomization
measure: Cholesterol
timeFrame: Week 64 - 88 post study randomization
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: PBRC
name: John W Apolzan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001230: Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter
Official title: Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lesions of the Anal Sphincter
Keywords: Lesions of the anal sphincter
Anal sphincter
Sexual health
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019

Brief summary: Lesions of the anal sphincter complicate 0.8% of childbirth in France. The sexual health of patients following this type of lesion is little studied, there are only about twenty articles on the subject.

The objective of this search is to study of the obstetric lesions of the anal sphincter


Eligibility criteria: Inclusion criteria:

* Adult woman (≥18 years old)
* Patient who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019
* Single pregnancy
* 3rd degree or 4th degree perineal tear
* Intact perineum (control group)
* Good understanding of French orally
* Patient accepting to participate in the satisfaction telephone interview and not having expressed her opposition to the reuse of her data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Cesarean delivery
* Multiple pregnancy
* Premature delivery
* stillborn child
* impossibility of providing the subject with enlightened information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or guardianship
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Retrospective study of obstetric lesions of the anal sphincter
timeFrame: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
name: Solène PETRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680130: Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
Official title: Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: PSP
CBD
PCA
LPA
Semantic Dementia
Semantic Aphasia
Behavioral Variant of Frontotemporal Dementia
FTD
PPA
Apraxia of Speech
MSA - Multiple System Atrophy
Parkinson Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptoms of neurodegenerative disease

Brief summary: The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

Detailed description: The investigators will recruit participants with symptoms suggestive of a neurodegenerative and/or related disease. Participants could be evaluated on a yearly basis, undergoing a baseline visit and possible follow-up evaluations with an interval of one year. At each visit, participants could undergo any combination of the following based on their symptoms and complaints: a neurological assessment, a speech/language assessment, a neuropsychometric assessment, an MRI, an FDG PET/CT scan, a PiB PET/CT scan, a Tau PET/CT scan and/or a C-11 ER176 PET/CT scan. All participants will be asked to provide a blood sample to allow for future genetic studies.

Eligibility criteria: Inclusion Criteria:

* All participants will be over the age of 21
* Have symptoms suggestive of a neurodegenerative and/or related disorder

Exclusion Criteria:

* Participants will be excluded if they have any concurrent illnesses that could account for all of their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes
* Women that are pregnant or post-partum and breast-feeding will be excluded
* Participants will be excluded if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, Hypogammaglobulinemia, Wiskott-Aldrich syndrome and Down's syndrome
* Participants will be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts)
* Participants will be excluded if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy)

Primary outcomes:
measure: Imaging analysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT04278430: Transcranial Direct Current Stimulation for Attention Deficit
Official title: Does Transcranial Direct Current Stimulation Affect Selective Visual Attention in Children With Left-sided Infantile Hemiplegia? A Preliminary Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Hemiplegia
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infantile hemiplegia due to brain injury is associated with poor attention. Left-sided infantile hemiplegia affects the learning and acquisition of new skills. This study is aiming to improve the Selective visual attention (SVA) through transcranial direct current stimulation (tDCS) in children with Left-sided infantile hemiplegia .

Detailed description: Infantile hemiplegia (IH) refers to brain injuries that occur before or at birth and lead to hemiplegia/ total paralysis of one side of the body, including the face, arm and leg. The IH is quit rare condition and occurs in 1 in 1000 live births. however, the condition is reported to cause functional and cognitive disability. Children with IH suffer from poor attention particularly visual attention, that is essential to be understand the written language. A focused reading is essential in learning and children with IH possess moderate intelligence and attend school.

Transcranial direct current stimulation(tTCS) is a novel intervention that use small amplitude electrical currents to stimulate the essential areas of the brain through surface electrodes placed on the corresponding areas of the brain.

The eligible children were divided into two groups. one group received tDCS with visual attention activities and the second group received sham tDCS with similar activities. The effect will be assessed before and after with Strops-color testing and a academic reading test.

The experiment intends to explore the affect of tTCS on visual attention span among children with Left-sided infantile hemiplegia.

Eligibility criteria: Inclusion Criteria:

* Age between 8-15 years
* Left-sided infantile hemiplegia
* lesion to non-dominant hemisphere

Exclusion Criteria:

* History of epilepsy
* second stroke
* color blind
* under medication for psychiatric illness

Primary outcomes:
measure: The Computerized Stroop Color-Word Test
timeFrame: 3 weeks
Secondary outcomes:
measure: academic practical test
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03641430: The Effects of Over-the-Counter Products on the Skin
Official title: The Effects of Over-the-Counter Products on the Skin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this study is to investigate the safety and tolerability of commonly used over-the-counter products and the effects of the products on skin health.

Detailed description: Participant will apply commonly used skin product on skin for a period of time with or without light challenge. The investigators will perform clinical assessments of the skin associated with product application as well as assess these changes with and without light challenge. Skin biopsies will be obtained following standard medical practice and will be used to analyze skin markers related to photoaging, pigmentation, oxidative stress, and other dermatologic conditions.

Eligibility criteria: Inclusion Criteria:

* Participants must be over the age of 18 years old with healthy skin;
* Participant must be willing and comply with the requirements of the protocol;
* Participant must have the ability to understand and communicate with the investigator;
* Participant must provide informed consent.

Exclusion Criteria:

* Subjects who are unable to provide informed consent;
* Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
* Subjects who self-report that they are pregnant or nursing;
* Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
* Subjects with known bleeding disorders or diathesis;
* Subjects with a history of keloids or excessive scarring;
* Subjects with known allergy to lidocaine, epinephrine, or any of the tested products;
* Subjects who foresee intensive UV exposure during the study (e.g. sunbathing, tanning beds).

Primary outcomes:
measure: Photoaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anna Chien
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naylor EC, Watson RE, Sherratt MJ. Molecular aspects of skin ageing. Maturitas. 2011 Jul;69(3):249-56. doi: 10.1016/j.maturitas.2011.04.011. Epub 2011 May 25.
Clinical trial NCT04621630: Pharmacokinetics of PN-235 in Healthy Volunteers
Official title: A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Protagonist Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-09
Enrollment: 107
Sex: ALL
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 Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect of food study.

Detailed description: Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses.

Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days.

Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion.

In total, approximately 102 subjects will participate.

Eligibility criteria: Key Inclusion Criteria:

* Subjects must have BMI between 18 and 32
* Subjects must be non-smokers or social smokers
* Subjects must comply with contraception requirements
* Subjects must be willing to consume meals provided by the clinical center

Key Exclusion Criteria:

* Subject must not have history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
* Subjects must not have history of surgical resection of the stomach, small or large intestine
* Subjects must not have fever or symptomatic viral or bacterial infection within 2 weeks of screening
* Subjects must not have corrected QT greater than 450 msec in males and 470 msec in females
* Subjects must not test positive for Hepatitis C or B at Screening
* Subjects must refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study

Primary outcomes:
measure: Safety of PN-235
timeFrame: 10 days
Secondary outcomes:
measure: Pharmacokinetics (PK) of PN-235 in plasma
timeFrame: 10 days
measure: Area Under the Concentration (AUC) of PN-235
timeFrame: 10 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Melbourne Clinic
Study officials:
References:
Clinical trial NCT03512730: A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL
Official title: BENEFITS OF A NEW MECHANICAL DECONTAMINATION METHOD, TI-BRUSH, ON THE ADJUNCT TREATMENT OF REGENERATIVE THERAPY OF PERI-IMPLANTITIS LESIONS: 12-MONTH OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peri-Implantitis
Keywords: regenera
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective:

The objective of this study was to evaluate a new mechanical method (Ti-Brush, Straumann, AG, Basel, Switzerland) of implant surface decontamination.

Material and methods:

A randomized double-blinded controlled clinical trial with a 1-year follow-up it is being carried out. After a hygienic phase, defects were randomly assigned to a control (n=18) or to a test group (n=18). In control group, implant surface was decontaminated both mechanically and chemically with 3% H2O2 and plastic ultrasonic scalers, respectively, while in test group Ti-Brush was added. Infrabony defects in both groups were regenerated with BoneCeramic (Straumann, AG, Basel Switzerland) and collagen barrier membrane Cytoplast (Osteogenics, Lubbock, United States). Clinical and radiographic parameters were measured at baseline, 6, and 12 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Healthy or treated periodontal patients
* A good level of oral hygiene (Plaque Index ≤ 25%) (O'Leary et al., 1972).
* Presence of at least one titanium implant exhibiting peri-implantitis (peri-implant bone loss \> 30% and Implant PPD ≥ 6 mm with bleeding and/or pus suppuration on probing)
* Osseous defect had to be circumferential, or present at least two walls and 3mm depth.
* Presence of \>1 mm of keratinized peri-implant mucosa
* Absence of systemic diseases that could influence the outcome of the therapy.

Exclusion Criteria:

* Pregnant or lactating women
* Esthetically compromised patients
* Patients who received systemic antibiotics in the past 3 months or treatment of peri-implantitis in the last 12 months.
* Smokers of more than 10 cigarettes a day

Primary outcomes:
measure: Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: