louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06104462: Exploring the Cortical Hemodynamic Variability of Prefrontal ITBS: a Concurrent TBS/fNIRS Study
Official title: Exploring the Cortical Hemodynamic Variability of Prefrontal ITBS: a Concurrent TBS/fNIRS Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: An increasing number of studies have used the intermittent theta-burst stimulation (iTBS) protocol to investigate neural plasticity non-invasively in the prefontal cortex in healthy humans and in patients with psychiatric disorders. However, the variability in the neurophysiological response to iTBS stimulation is high. The cause of this variability is multifactorial and to some degree still unknown. Therefore, the current study explores inter- and intra-individual factors that are potentially moderating iTBS-induced excitability changes. A greater understanding of these determinants would be highly valuable for optimizing the therapeutic application of iTBS.

Detailed description: The investigators will measure the cortical excitability induced by iTBS with concurrent TBS/fNIRS technique in the same healthy individuals on multiple testing days. Meanwhile, several potential inter- (age, gender, etc.) and intra-individual factors (daily mood, daily physical activity levels, etc.) recently identified in non-invasive transcranial brain stimulation studies will be assessed before applying iTBS to the same individual on each testing day.

Eligibility criteria: Inclusion Criteria:

* healthiness based on history and psychiatric assessment
* being able to hear and understand the verbal instructions
* completed at least 6 years of formal education

Exclusion Criteria:

* a current or past diagnosis of psychiatric, neurological disorders, or severe internal illness
* any conditions that will contraindicate to iTBS or fNIRS
* psychiatric disorders in their first-degree relatives
* pregnancy

Primary outcomes:
measure: Oxygenated hemoglobin (HbO) change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 3 months
Secondary outcomes:
measure: Deoxygenated hemoglobin (HbR) change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 3 months
measure: Oxygen saturation change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Georg Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05126862: Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Official title: Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Huntington Disease
Parkinson Disease
Keywords: Anxiety
Interpretation bias
Cognitive bias modification
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-11-19
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is conduct a pilot open trial of a web-based cognitive bias modification intervention to reduce anxiety symptoms in persons with Huntington's disease and persons with Parkinson's disease.

Detailed description: After being informed about the study and giving informed consent, participants will enroll in a pilot open trial of MindTrails, a web-based cognitive bias modification intervention. Participants will complete five, 20-minute MindTrails training sessions over five weeks. Additionally, assessments of anxiety, interpretation bias, and other related outcomes will be completed at baseline, week 3, week 5, and 2 months following the last training session. Participants will each complete a semi-structured interview to provide qualitative feedback about their experiences with MindTrails and anxiety.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Huntington's disease or Parkinson's disease
* Age 21 or older
* Has anxiety symptoms (NeuroQoL Anxiety short form \>12)

Exclusion Criteria:

* Unable to read and understand English
* Previously diagnosed with dementia
* Not located in the USA

Primary outcomes:
measure: Proportion of Participants Completing at Least 50% of the MindTrails Sessions
timeFrame: Between baseline and week 5
measure: Participant Perceptions of Perceived Benefits and Limitations of MindTrails
timeFrame: After completion of the intervention (week 5)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jessie S Gibson, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315562: Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis
Official title: Pilot Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Stroke
Carotid Stenosis
Keywords: stroke
carotid stenosis
carotid endarterectomy
timing
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-04-18
Enrollment: 0
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: Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Detailed description: Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older.
* New small to medium-sized ischemic stroke (defined as less than 1/3 of the MCA territory) in the territory of 70% or greater carotid stenosis.
* Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

Exclusion Criteria:

* Patients judged to be a poor surgical candidate by the treating physicians.
* Unstable neurological status.

Primary outcomes:
measure: modified Rankin Score
timeFrame: 90 days
Secondary outcomes:
measure: stroke incidence
timeFrame: 90 days
measure: transient ischemic attack incidence
timeFrame: 90 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD
name: Matt B Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00288262: Melatonin Effects on Luteinizing Hormone
Official title: Melatonin Effects on Luteinizing Hormone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hot Flashes
Keywords: hot flashes
melatonin
depression
sleep
luteinizing hormone
postmenopause
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2006-02-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes. Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and relieve hot flashes.

Detailed description: Twenty postmenopausal women troubled by hot flashes underwent one week of baseline observation followed by 4 weeks of a randomized controlled trial of melatonin or matched placebo. The three randomized treatments were melatonin 0.5 mg 2.5-3 hours before bedtime, melatonin 0.5 mg upon morning awakening, or placebo capsules. Twelve of the women were admitted to the GCRC at baseline and at the end of randomized treatment for 24-hour sampling of blood for LH. Morning urine samples were collected twice weekly to measure LH excretion. Subjective responses measured throughout baseline and treatment included sleep and hot flash logs, the CESD and QIDS depression self-ratings, and the SAFTEE physical symptom inventory.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman
* Troubled by hot flashes

Exclusion Criteria:

* Use of reproductive hormones other than continuous estrogen or progesterone hormone replacement
* Any acute illness
* Any anticipated changes of medication
* Anemia (hemoglobin \<12) or poor veins Recent trans-time-zone jet travel, shift work, or irregular sleep habits Any neurological or pituitary disease

Primary outcomes:
measure: Hot flashes log
measure: Sleep log
measure: QIDS
measure: CESD
measure: Luteinizing hormone (urine)
measure: Luteinizing hormone (blood)
Secondary outcomes:
measure: SAFTEE inventory of symptoms and adverse effects
measure: Other adverse events
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Sleep Center
state: California
Study officials:
affiliation: Scripps Clinic Sleep Center
name: Daniel F Kripke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201862: Non-Invasive Chromosomal Evaluation of Trisomy Study
Official title: Non-Invasive Chromosomal Evaluation of Trisomy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneuploidy
Trisomy 21
Trisomy 18
Trisomy 13
Down Syndrome
Keywords: Aneuploidy
Down Syndrome
amniocentesis
chronic villus sampling
Trisomy
non-invasive prenatal testing
Chromosome disorders
Lead sponsor: Roche Sequencing Solutions
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women planning to undergo chorionic villus sampling (CVS) and/or amniocentesis for the purpose of genetic evaluation of the fetus.

Brief summary: This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.


Eligibility criteria: Inclusion Criteria:

* 1. Subject is at least 18 years old and can provide informed consent;
* 2. Subject has a viable singleton or twin pregnancy;
* 3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
* 4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.

Exclusion Criteria:

* 1. Subject has known aneuploidy;
* 2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
* 3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
* 4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;

Primary outcomes:
measure: Detection of aneuploidy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University California San Diego
state: California
city: Oaks
country: United States
facility: Women's Healthcare Group of PA
state: Pennsylvania
city: Chattanooga
country: United States
facility: Regional Obestrical Consultants
state: Tennessee
Study officials:
References:
citation: Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1.
Clinical trial NCT02038062: Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery
Official title: Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Oxygen Saturation
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.

Detailed description: Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.

Eligibility criteria: Inclusion Criteria:vascular surgery with clamping of a femoral artery. -

Exclusion Criteria:

-

Primary outcomes:
measure: Decrease of tissue oxygen saturation below 95 % of baseline
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Axel Fudickar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fudickar A, Kunath S, Voss D, Siggelkow M, Cavus E, Steinfath M, Bein B. Effect of ischemic and pharmacological preconditioning of lower limb muscle tissue on tissue oxygenation measured by near-infrared spectroscopy--a pilot study. BMC Anesthesiol. 2014 Jul 15;14:54. doi: 10.1186/1471-2253-14-54. eCollection 2014.
Clinical trial NCT00480662: A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)
Official title: A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paget's Disease of Bone
Keywords: Paget's bone disease
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.


Eligibility criteria: Inclusion Criteria:

* Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

Exclusion Criteria:

* Patient cannot stand or sit upright for at least 30 minutes
* Patient has difficulty swallowing or problems with digestive system

Primary outcomes:
measure: Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary outcomes:
measure: MK0217 will be safely tolerated
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hooper M, Faustino A, Reid IR, Hosking D, Gilchrist NL, Selby P, Wu M, Salzmann G, West J, Leung A. Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease. Osteoporos Int. 2009 Jan;20(1):141-50. doi: 10.1007/s00198-008-0639-6. Epub 2008 Jun 7.
Clinical trial NCT03930862: Ball and Socket Versus Locator Attachment Retained Implant Overdentures
Official title: Comparison of Muscle Activity and Patients Satisfaction on Implants Supported Overdenture Using Ball and Socket Versus Locator Attachment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Edentulism
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture? '

Detailed description: In this study we will use a two different types of attachments in implants overdenture in mandibular completely edentulous patients to increase the retention and stability of the denture and this can be recognized by record the masticatory function of the muscles of the mandibular jaw.

Eligibility criteria: Inclusion Criteria:

- Upper and lower completely edentulous patients. Acceptance of the existing denture if it is good, or constructing a new one if it is defected.

Patients with adequate bone quality and quantity. Tooth extracted not less than 6 month.

Exclusion Criteria:

1. Young patients.
2. Diseases affecting neuromuscular coordination.
3. TMJ diseases.
4. Soft tissue abnormalities.
5. Bony exostosis.
6. Parathyroid dysfunction
7. uncontrolled Diabetes
8. Radiotherapy to the neck or head
9. Pregnancy.
10. Drug and alcohol dependency.
11. Smokers.

Primary outcomes:
measure: Muscle Activity
timeFrame: 6 month
Secondary outcomes:
measure: Patient Satisfaction: questionnaire
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer of Prosthdontics
name: Nada Sherine, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02924662: The Investigation of the Depression in Osteoarthritis
Official title: The Investigation of the Depression in Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Lead sponsor: Dalian Municipal Central Hospital
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will be taken from a single centre. The patient population will be patients who are diagnosed with osteoarthritis. Participants will have a comprehensive and detailed assessment by a qualified doctor. After the assessment，the participants who are diagnosed with osteoarthritis and conformed to fit the eligibility criteria will be invited to join the investigation.

Brief summary: Studies have reported that the patient's psychological state such as anxiety, depression and other emotion affect the therapeutic effect of osteoarthritis, also may be the important reason for the poor knee joint osteoarthritis efficacy.

The aim of this study are firstly to investigate the depression status of patients with osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression will affect depression status, ultimately, provide reference for clinical.


Eligibility criteria: Inclusion Criteria:

Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis and the 2010 Chinese Medical Association clinical criteria for knee osteoarthritis.

Exclusion Criteria:

Patients with rheumatoid arthritis patients with a history of depression before osteoarthritis pathogenesis patients who can't cooperate with related inspection and assessment Patients with mental illness

Primary outcomes:
measure: Western Ontario and McMaster OA index (WOMAC)
timeFrame: Day 1
measure: American knee society knee score
timeFrame: Day 1
measure: Hamilton Depression Scale-17（HAMD-17）
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: