louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06470711: Mapping of Electrical Properties in the Brain
Official title: Mapping of Electrical Properties in the Brain.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Glioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and clinical neuro-oncology subjects with high grade glioma

Brief summary: This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.

Detailed description: PRIMARY OBJECTIVES:

I. Optimize pulse sequence acquisitions for diffusion imaging on clinical MRI vendor systems.

II. Develop image-based MRI models (including diffusion-based MRI) that accurately depict the multi-regional electrical properties in the brain (e.g., resistivity, current) to inform of neural integrity and function (including white matter tract integrity) in diseased and non-diseased states.

III. Compare/correlate image-based MRI models (e.g., diffusion) with existing structural, physiologic, and functional MRI methods (e.g., tensor imaging, fMRI, DSC-MRI, etc).

IV. Further train image-based models/measurements with loco-regional benchmarks including (but not exclusive to) electrophysiologic monitoring, functional and structural tissue assays (from available biopsies), and correlative clinical features (e.g., histology, outcomes, treatment, etc).

OUTLINE: This is an observational study.

Participants complete a survey and undergo MRI on study.

Eligibility criteria: Inclusion Criteria:

* Aim 1: normal healthy volunteers
* Aim 2, 3, 4: participants included in IRB 16-002424, including those that have undergone surgical biopsy/resection for suspected or known glioma

Exclusion Criteria:

* Healthy volunteer unable to have an MRI

Primary outcomes:
measure: Identify diffusion MRI metrics [using conductivity tensor imaging (CTI)] that inform of regional electrical properties in the brain
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Leland S. Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02391311: A Novel Neurorehabilitation Approach for Cognitive Aging With HIV
Official title: Speed of Processing Training With Transcranial Direct Current Stimulation in Older HIV+ Adults (HtDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Aging
Keywords: tDCS
Cognitive remediation therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to conduct a small, self-contained project to test the hypothesis that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tDCS condition.


Eligibility criteria: Inclusion Criteria:

* HIV+
* Aged 50 and older
* Patient at University HIV/AIDS Clinic

Exclusion Criteria:

* Not homeless
* Not blind or deaf
* No significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures)
* No pacemaker or other biomedical devices or metal implants
* No untreated hypertension
* Not undergoing chemo or radiation
* No head injury with LOC greater than 30 mins

Primary outcomes:
measure: Change in the Processing of Speed
timeFrame: baseline, 6 week posttest
Secondary outcomes:
measure: Change in Driving Simulator Performance
timeFrame: baseline, 6 week posttest
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB 1917 Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Pariya L Fazeli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705211: A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)
Official title: Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Familial Hypercholesterolemia
Homozygous Sitosterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2008-06-25
Enrollment: 1794
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be selected from 200 institutions in Japan.

Brief summary: This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed description: The population will be selected from 200 institutions in Japan.

Eligibility criteria: Inclusion Criteria:

* Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.

Zetia monotherapy patients must be treated with Zetia alone.

Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.

Exclusion Criteria:

* Patients with a history of hypersensitivity to any ingredient in Zetia
* Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.

Primary outcomes:
measure: A primary endpoint is the incidence of adverse events.
timeFrame: Adverse events will be monitored throughout the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
measure: A primary endpoint is change in LDL-C
timeFrame: LDL-C at start of 52 weeks will be compared to LDL-C at the end of the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04169893: A Phase I Study of TS-142 in Healthy Participants (Single Doses)
Official title: A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection

Exclusion Criteria:

* History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
* History of drug and food allergy

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
timeFrame: Day 1 up to Day 8
measure: Area under the concentration-time curve AUC (tau)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: The medical facility selected by Taisho Pharmaceutical Co., Ltd
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
citation: Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.
Clinical trial NCT04718493: Endoscopic Stenting in Crohn Related Strictures
Official title: Endoscopic Stenting in Crohn Related Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Strictures Related to Crohn´s Disease
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 13
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: Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.


Eligibility criteria: Inclusion Criteria:

* Benign high-grade Crohn stricture

Exclusion Criteria:

* Unwillingness to participate
* Planned surgery
* High risk for bleeding

Primary outcomes:
measure: Technical success rate
timeFrame: Peroperative
measure: Adverse event rate
timeFrame: Within 7 days
Secondary outcomes:
measure: Clinical success rate
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Sahlgrenska University Hospital
name: Per-Ove Stotzer, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.
Clinical trial NCT02486393: Complications in Parotid Surgery
Official title: Complications in Parotid Surgery - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Palsy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled

Brief summary: The investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. Their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. Also other complications occurring within 12 months of operation were recorded.

Detailed description: Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled. Exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.

Eligibility criteria: Inclusion Criteria:

* parotid gland tumour surgery

Exclusion Criteria:

* age under 18
* suspicion of malignancy or facial schwannoma
* a tumor extending into the parapharyngeal space
* previous parotid surgery exposing facial nerve

Primary outcomes:
measure: facial palsy
timeFrame: post op 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04724993: Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever
Official title: Comparison the Effectiveness of Online Aerobic Dance Exercises Versus Physical Activity Counseling in Patients With Juvenile Familial Mediterranean Fever
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Familial Mediterranean Fever
Exercise
Physical Activity
Keywords: Familial Mediterranean Fever
Online Exercise
Physical Activity Counseling
Aerobic Dance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate comparison the effectiveness of online aerobic dance exercises versus physical activity counselling in patients with Juvenile Familial Mediterranean Fever.


Eligibility criteria: Inclusion Criteria:

* To be under colchicine treatment for at least 3 months
* Being in an attack-free period

Exclusion Criteria:

* Attack in the last 2 weeks
* Having any systemic chronic disease except Familial Mediterranean Fever
* Presence of amyloidosis
* Having arthritis that may prevent participation in exercise

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Progressive Aerobic Cardiovascular Endurance Run (PACER)
timeFrame: Change from baseline to 8 weeks
measure: Skinfold Thickness Measurement and Bioelectrical Impedance Analysis
timeFrame: Change from baseline to 8 weeks
measure: Curl Up Test
timeFrame: Change from baseline to 8 weeks
measure: Trunk Lift Test
timeFrame: Change from baseline to 8 weeks
measure: Push Up Test
timeFrame: Change from baseline to 8 weeks
measure: Back saver Sit and Reach Test
timeFrame: Change from baseline to 8 weeks
measure: Physical Activity Questionnaire for Older Children (PAQ-C)
timeFrame: Change from baseline to 8 weeks
measure: Physical Activity Questionnaire for Adolescents (PAQ-A)
timeFrame: Change from baseline to 8 weeks
measure: PedsQL™ Multidimensional Fatigue Scale
timeFrame: Change from baseline to 8 weeks
measure: Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
timeFrame: Change from baseline to 8 weeks
measure: Visual Analogue Scale for Fatigue
timeFrame: Change from baseline to 8 weeks
measure: Visual Analogue Scale
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Saime Nilay ARMAN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01317693: Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Official title: Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: LI-ESWT
Erectile Dysfunction
ED
Shock waves
Therapy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.


Eligibility criteria: Inclusion Criteria:

* ED of more than 6 months
* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
* Positive response to PDE-5 inhibitors
* IIEF-5 domain score of 12-20 denoting mild to severe ED
* Non-Neurological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* NPT - normal/flat
* Prior prostatectomy surgery
* Any cause of ED other than vascular related
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Cardiovascular conditions that prevent sexual activity
* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
* Cancer within the past 5 years.
* Anti-androgens, oral or injectable androgens
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories

Primary outcomes:
measure: Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success
timeFrame: 13 weeks
Secondary outcomes:
measure: Rigidity Score Questionaire- an increase by at least 1 point is considered success
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ilan Gruenwald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Yoram Vardi, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05377593: Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation
Official title: Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Dislocation of Temporomandibular Joint (Disorder)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial A Trial will be carried out in hospital of Oral and Maxillofacial Surgery department- Faculty of dentistry Cairo University.

Equal Randomization: Participants receiving treatment. Positive Controlled: Both groups receiving treatment. Parallel group study: each group of patients receives single treatment simultaneously.
Primary purpose: TREATMENT

Brief summary: Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patient with recurrent dislocation with maximum inter incisal opening over 55mm
* Long-standing dislocation of the TMJ involving both fixation for more than 3 weeks and the failure of manual reduction
* Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage
* Both sexes
* Age between 18 and 48 years.
* Highly motivated patients.

Exclusion Criteria:

* Post-menopausal females with osteoporosis
* Patient with uncontrolled systemic disease
* pregnancy
* psychological disorders, drug or alcohol dependency
* Known allergies or sensitivities to dental materials, including Zirconia, Titanium or general anesthetic agents
* Inability to return for follow up visits.
* Refusal of participation from the patient

Primary outcomes:
measure: Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)
timeFrame: 6 months
Secondary outcomes:
measure: Patient's Pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Adham Zakaria
Study officials:
affiliation: Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University
name: Mohammed Kadry Nasr, Doctorate
role: STUDY_DIRECTOR
References:
Clinical trial NCT00180193: F-18-OMFD-PET for Radiotherapy Treatment Planning and Evaluation of Early Therapy Response
Official title: F-18-OMFD-PET for Radiotherapy Treatment Planning and Evaluation of Early Therapy Response
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Tumor
Keywords: Radiotherapy
F-18-OMFD
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Advanced Biochemical Compounds GmbH
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OMFD-PET of all patients after subtotal resection or biopsy of malignant glioma was evaluated.

Brief summary: The purpose of this study is to monitor the amino acid uptake of brain tumors, before and during radiotherapy, with positron emission tomography.


Eligibility criteria: Inclusion Criteria:

* Brain tumor
* Radiation therapy indicated
* Written consent

Exclusion Criteria:

* Pregnancy
* Mental impairment
* Drug/alcohol abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Nuclear Medicine
Study officials:
affiliation: Department of Nuclear Medicine
name: Joerg Kotzerke, MD
role: PRINCIPAL_INVESTIGATOR
References: