louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05002764: Thalamic Nuclei Volumes in Multiple Sclerosis
Official title: Differential Vulnerability of Individual Thalamic Nuclei: Toward New Biomarkers in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Thalamus
Nuclei
Atrophy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-08-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple Sclerosis and at least one MRI that includes 3D T1 and FLAIR at 1.5T or 3T.

Brief summary: The thalamus is composed of several nuclei interlocked in a complex anatomy. In multiple sclerosis (MS), the thalamus can be altered due to disconnection by white matter lesions and due to direct damages that could be partly mediated by CSF. Due to such pathophysiology and complex anatomy, some nuclei could be more vulnerable to multiple sclerosis than others. We will test this hypothesis by using a new algorithm to automatically segment several nuclei that we will be applied to the French national MS database


Eligibility criteria: Inclusion Criteria :

* Patient older than 18 years old.
* With Multiple Sclerosis according to Mc Donald 2017 criteria or with clinically isolated syndrome and included with OFSEP cohort.
* Phenotype known (RR, SP, PP or CIS).
* Date of diagnosis known.
* With at least one MRI that includes 3D T1 and FLAIR at 1.5T or 3T.

Exclusion Criteria :

* Stroke
* Other causes of dementia not caused by Multiple Sclerosis (Alzheimer's disease, Parkinsonian syndromes...)

Primary outcomes:
measure: Volume of thalamic nuclei
timeFrame: At inclusion in the cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
Clinical trial NCT00169364: Clinical, Molecular and Metabolic Characteristics of Parkinson's Disease (PD) Patients With Parkin Mutation
Official title: Comparison of Clinical, Molecular and Metabolic Characteristics of PD Patients With and Without Parkin Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
parkin mutation
Juvenile parkinson's disease
positron emission tomography
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
First posted: 2005-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease have been recently identified. The monogenic form due to parkin mutation is responsible for many familial cases and sporadic forms. However, the relationship between the mutation and the genotype of patients is not fully established. The aim of this study is to compare clinical, metabolic and neuropsychological characteristics obtained in patients with parkin mutation with those of patients without parkin mutation.


Eligibility criteria: Inclusion Criteria:

* Juvenile Parkinson's disease (\< 45 years)
* Parkin mutation
* Normal brain magnetic resonance imaging (MRI)

Exclusion Criteria:

* Contraindication to brain MRI
* Women without effective contraception

Primary outcomes:
measure: Parkin mutation
measure: Motor disability
measure: Neuropsychological evaluation
measure: Psychiatric evaluation
Secondary outcomes:
measure: Positron emission tomography
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Alexis Brice, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00707564: Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
Official title: A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tooth Extractions
Keywords: hemostasis
tooth extractions
Lead sponsor: HemCon Medical Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications.

Detailed description: As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigate the safety and efficacy of hemostasis of the dressing for use in dental surgical procedures that do not require primary closure (suturing) such as tooth extractions. This protocol will specifically research the safety and efficacy of hemostasis within a population of subjects taking anticoagulant medications.

Eligibility criteria: Inclusion Criteria:

* Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
* Patients requiring a minimum of 2 tooth extraction procedures.
* Index pairing must reflect anatomically similar extraction locations
* 14 years of age or older
* Available for a minimum of one post operative evaluation approximately 7 days post surgery
* Extraction sites do not require primary closure or suturing
* Willingness and ability to provide informed consent/ assent

Exclusion Criteria:

* Scheduled to undergo a procedure other than tooth extractions
* In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
* Scheduled to undergo 2 extractions, anatomically dissimilar
* Extraction procedures are expected to require primary closure or suture
* Unwilling or unable to provide informed consent/ assent
* Patients undergoing bisphosphonate therapy
* Patients not under current treatment with an oral anticoagulant medication
* Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit

Primary outcomes:
measure: Time to hemostasis
timeFrame: minutes after application
Secondary outcomes:
measure: Incidence of post surgical sequela
timeFrame: 1 week post surgery
Other outcomes:
Locations:
city: Milwaukie
country: United States
facility: Rodney Nichols, DMD
state: Oregon
city: Portland
country: United States
facility: Jay P. Malmquist, DMD
state: Oregon
Study officials:
affiliation: Jay P. Malmquist, DMD, PC
name: Jay Malmquist, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122964: Multi Institutional Study in Patient Presenting With Hematuria
Official title: Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Hematuria
Lead sponsor: MDx Health
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 1148
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months

Brief summary: The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

Detailed description: The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

The secondary objective is to evaluate the predictive accuracy of a risk model including clinical factors such as age, gender, smoking history, and presence of gross versus microscopic hematuria compared to a model incorporating the same risk factors along with the methylation marker panel.

Eligibility criteria: Inclusion Criteria:

1. Subject is willing and able to give written informed consent
2. Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months

Exclusion Criteria:

1. Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days)
2. Subject has a current or past history of genitourinary or urologic cancer within 5 years
3. Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years

Primary outcomes:
measure: Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.
timeFrame: 1 year
Secondary outcomes:
measure: Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
References:
Clinical trial NCT00754364: Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients
Official title: A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 108
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone.

Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients.

A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.


Eligibility criteria: Inclusion Criteria:

* NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Female or male patients aged 70 years and over
* Measurable disease according to RECIST criteria, with at least one measurable lesion
* No prior chemotherapy, biological or immunological therapy
* Adeguate hepatic, renal and bone marrow function
* ECOG Performance Status ≤ 2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Newly diagnosed CNS metastases that have not been treated with surgery or radiation
* Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
* Any other experimental or anti-cancer therapy within 30 days before study drug administration
* Concurrent treatment with any other experimental or anti-cancer therapy

Primary outcomes:
measure: Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients.
timeFrame: Efficacy after the inclusion of the last patient
Secondary outcomes:
measure: Overall Survival Quality of life
timeFrame: After the follow up period
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinco Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05920564: Upper Trapezius Stretching in Patients With Cervical Spondylosis
Official title: Efficacy of Upper Trapezius Stretching on Neck Pain, Range of Motion and Disability in Patients With Cervical Spondylosis: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spondylosis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effectiveness of upper trapezius stretching exercises on pain intensity, neck range of motion, and disability in patients with cervical spondylosis. Patients with diagnosed cervical spondylosis will be randomly assigned to either a study group performing upper trapezius stretches or a control group. Both groups will receive heat treatment and strengthening exercises. The study group will additionally perform specific upper trapezius stretching exercises. Outcomes measures will be assessed before and after 4 weeks of intervention and will include neck pain intensity, range of motion, and disability using the Neck Disability Index. The study hypothesizes that the study group will demonstrate greater improvements in pain, range of motion, and disability compared to the control group. The study findings could provide data to guide physical therapy management of cervical spondylosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cervical spondylosis confirmed by orthopedic specialist
* Presence of neck pain for at least 3 months
* willingness to participate in the study and comply with the intervention

Exclusion Criteria:

* Recent neck trauma or fractures (within 6 months)
* Previous neck surgery
* Concurrent medical conditions that could affect neck pain and range of motion (e.g. rheumatoid arthritis)
* Concurrent physical therapy or rehabilitation for neck or shoulder
* Use of corticosteroids within past 3 months
* Pregnancy or serious circulatory conditions (due to use of heat pack)
* Known hypersensitivity to heat or cold
* Cognitive impairment that could interfere with ability to understand and complete self-report questionnaires and comply with interventions

Primary outcomes:
measure: Changes in Neck pain intensity
timeFrame: Changes in neck pain intensity at baseline and after 4 weeks of intervention and 3 months
measure: Changes in Neck range of motion
timeFrame: Changes in neck range of motion at baseline and after 4 weeks of intervention and 3 months
Secondary outcomes:
measure: Changes in Neck Disability Index
timeFrame: Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT02369302: Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers
Official title: An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 45 years
2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
2. A subject who shows the following result in clinical laboratory test

   * AST, ALT \> 1.25 times of the upper limit of normal range
   * PR ≥ 210 msec
   * QRS ≥ 120 msec
   * QT ≥ 500 msec
   * QTcF ≥ 500 msec
3. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Primary outcomes:
measure: Cmax,ss
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: AUCtau
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary outcomes:
measure: Cmin,ss
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Tmax
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: t1/2
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Metabolic Ratio
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University College of Medicine Busan Paik Hospital
state: Busanjin-gu
Study officials:
affiliation: BUSAN PAIK HOSPITAL
name: Eun-Young Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03085602: Neuroimaging Studies of Smoking and Treatment
Official title: Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.


Eligibility criteria: Inclusion Criteria:

* smoke \> 10 cigarettes per day
* vision is normal or corrected-to-normal

Exclusion Criteria:

* serious medical illness unsuitable for the MR scanner based on best clinical judgment
* any neurologic or psychiatric disorder
* diabetes
* known heart disease
* high blood pressure
* currently taking psychotropic or cardiovascular medication
* history of alcohol or other substance dependence or current abuse
* risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
* pregnancy

Primary outcomes:
measure: Change in activation in reward processing regions of the brain
timeFrame: Change from Baseline to Week 4
Secondary outcomes:
measure: Change in activation in cognitive control regions of the brain
timeFrame: Change from Baseline to Week 4
measure: Change in connectivity between reward and cognitive control regions of the brain
timeFrame: Change from Baseline to Week 4
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Hoglund Brain Imaging Center, University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Laura Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02795702: tDCS Effects on Associative Learning in Older Adults of Working Age
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: tDCS
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.


Eligibility criteria: Inclusion Criteria:

* Age: older in working age (50-65 years)
* Right handedness
* unobtrusive neuropsychological screening

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).

Primary outcomes:
measure: Performance in a verbal associative learning paradigm under anodal tDCS compared to sham
timeFrame: assessed immediately after training period (several learning blocks) compared to sham
Secondary outcomes:
measure: Functional connectivity predictors
timeFrame: assessed during baseline testing
measure: Structural predictors
timeFrame: assessed during baseline testing
measure: Genotyping of learning related polymorphisms
timeFrame: : assessed during baseline screening
measure: Other cognitive outcome: Attention
timeFrame: assessed directly before and immediately after tDCS + training compared to
measure: Other cognitive outcome: Working memory
timeFrame: assessed directly before and immediately after tDCS + training compared to
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.
citation: Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. doi: 10.1016/s0165-0270(01)00525-8.
citation: Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. doi: 10.1016/j.neuroimage.2004.12.019.