louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05353764: Effect of Scalp Nerve Block on the Recovery Quality of Parkinson's Patients After Deep Brain Stimulation
Official title: Effect of Scalp Nerve Block Combined With Intercostal Nerve Block on Quality of Recovery After Deep Brain Stimulation in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients diagnosed with Parkinson's disease (PD) undergoing deep Brain Stimulation (DBS) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (QoR) resulting in longer hospitalization time and higher hospital costs. Scalp nerve block (SNB) combined with intercostal nerve block (ICNB)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with PD was unclear. Therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after DBS surgery.


Eligibility criteria: Inclusion Criteria:

* patients with PD who receive elective deep brain stimulation (DBS) surgery
* Aged ≥ 18
* American Society of Anesthesiologists (ASA) physical status of I-III
* Able to communicate normally

Exclusion Criteria:

* Allergy to local anesthetics
* Pre-existing infection at block site
* Severe coagulopathy
* Pre-existing neuropathic pain condition
* Previous history of DBS surgery
* unwilling to provide informed consent or poor compliance

Primary outcomes:
measure: The 15-item QoR score
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: The 15-item QoR score
timeFrame: 72 hour and 1 month after surgery
measure: The NRS score
timeFrame: before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery
measure: The patients with PONV
timeFrame: 24 hour after surgery
measure: Consumption of opioid
timeFrame: during operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai hospital, Shanghai, China
name: Xiya Yu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheng Y, Wang H, Chang X, Jin P, Lin S, Qian S, Xie J, Lu W, Yu X. Effect of Scalp Nerve Block Combined with Intercostal Nerve Block on the Quality of Recovery in Patients with Parkinson's Disease after Deep Brain Stimulation: Protocol for a Randomized Controlled Trial. Brain Sci. 2022 Jul 29;12(8):1007. doi: 10.3390/brainsci12081007.
Clinical trial NCT06856564: Tongue Mobility in Patients with Ankyloglossia Following Frenectomy
Official title: Evaluation of Tongue Mobility in Patients with Ankyloglossia Following Frenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankyloglossia
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 33
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Hanoi National Hospital of Odonto-stomatology and Hanoi Medical University from December 2022 to December 2024

Brief summary: This study aimed to evaluate the improvement in tongue mobility in patients with ankyloglossia (tongue-tie) following frenectomy. Ankyloglossia restricts tongue movement, potentially causing issues with speech, swallowing, and dental malocclusion.


Eligibility criteria: Inclusion Criteria:

* (1) at least four years of age, (2) report a limitation in tongue mobility at least at the moderate class (class II) according to Kotlow criteria and did not response to tongue lengthening exercise.

Exclusion Criteria:

* Patients who have limited mouth openings that interfere with tongue mobility measurements and patients who have bad compliances due to mental problems or uncooperative children were excluded.

Primary outcomes:
measure: Kotlow index
timeFrame: 3 months
measure: Tongue-Incisive Papilla Distance
timeFrame: 3 months
measure: Comfortable Mouth Opening
timeFrame: 3 months
measure: Lingual - Palatal Suction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi National Hospital of Odonto-Stomatology
Study officials:
References:
Clinical trial NCT06502964: Study of ALTO-101 in Patients With Schizophrenia
Official title: Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Schizophrenia
Cognitive Impairment
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive both placebo and active study drug: 10-day administration each of placebo TDS and ALTO-101T TDS (in random order), with a 6- to 14-day washout period between conditions.
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.

Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia diagnosis for at least one year
* Cognitive impairment
* Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
* Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
* Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
* Willing to comply with all study assessments and procedures

Exclusion Criteria:

* Evidence of unstable medical condition
* Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
* Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
* Current episode of major depressive disorder (MDD)
* Use of mood stabilizer, clozapine, and/or daily benzodiazepine
* Current moderate or severe substance use disorder

Primary outcomes:
measure: Theta band activity
timeFrame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
timeFrame: Treatment Period Day 1 through study completion (an average of 36 days)
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Site 5038
state: California
city: Los Angeles
country: United States
facility: Site 5063
state: California
city: Hollywood
country: United States
facility: Site 5060
state: Florida
city: Chicago
country: United States
facility: Site 5056
state: Illinois
city: Gaithersburg
country: United States
facility: Site 5062
state: Maryland
city: New York
country: United States
facility: Site 5077
state: New York
Study officials:
References:
Clinical trial NCT05058664: Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit
Official title: Developing Text-based Support for Parents of Suicidal Adolescents After Emergency Department Visits: A Multi-component Intervention Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Emergency Department
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-09-28
Enrollment: 240
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 3 arms: control and 2 intervention arms. One of the intervention arms includes further twice daily (within-person) randomizations.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.

Detailed description: Participants in the trial included 120 youth-parent dyads (120 youths and 120 parents). As the ultimate focus of the intervention is on improving youth outcomes, participant-related descriptives are provided for youth participants, except where noted specifically to be parent-related data.

Eligibility criteria: Parent eligibility:

Inclusion Criteria:

* Parent of eligible teen

Exclusion Criteria:

* Not owning a cell phone with text messaging capability.

Teen eligibility:

Inclusion Criteria:

* Recent suicidal ideation (within last 2 weeks) and/or suicide attempt within the last month.

Exclusion Criteria:

* Youth with severe cognitive impairment or altered mental status (e.g., psychosis, manic state)
* Youth with severe aggression/agitation
* No availability of a legal guardian

Primary outcomes:
measure: Percentage of Eligible Youth-Parent Dyads Who Agree to Participate in the Study,
timeFrame: At the time of youth Emergency Department visit
measure: Participant Dyads Who Completed Follow-up Assessments
timeFrame: Up to 12 weeks
measure: Percentage of Participants Randomized to the Intervention Who Remained Active (Texting Arms Only)
timeFrame: Up to 6 weeks
measure: Participating Parents' Satisfaction With the Intervention (Texting Arms Only)
timeFrame: Up to 6 weeks
measure: Number of and Reasons for Active Withdrawals
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ewa Czyz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02452164: Family MobilePhone Otoscopy in Diagnostics of Otitis Media
Official title: Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: otoscopy
otitis media
cellphone
family
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-05-22
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.


Eligibility criteria: Inclusion Criteria:

* Age 6 - 35 mo
* Parents have iPhone 5, 5s or 6
* Child is in daycare
* Child has had at least one acute otitis media within 90 days preceding the enrollment
* Family agrees to give a mortgage of 40 euros from the CellScopeOTO

Exclusion Criteria:

* Tympastonomy tube present in tympanic membrane
* Chronic perforation of the tympanic membrane
* Condition of head/neck anomaly to affect middle ear or ear canal anatomy
* One child from the family already participating

Primary outcomes:
measure: diagnostic quality of tympanic membrane imagines
timeFrame: first study week
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: consultant
name: Aino Ruohola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872764: Acute Kidney Injury in Patients With CoVID-19
Official title: The Effect of Acute Kidney Injury on Prognosis in Patients Hospitalised for COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Acute Kidney Injury
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised for COVID-19 with and without acute kidney injury

Brief summary: We aimed to investigate the effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19.

Detailed description: The effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19. Patients hospitalised for COVID-19 and acute kidney injury will be enrolled. The duration of hospitalisation, mortality rates will be compared in COVID-19 patients with and without acute kidney injury.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalised with COVID-19.
* Patients hospitalised with COVID-19 with Acute Kidney Injury

Exclusion Criteria:

-

Primary outcomes:
measure: mortality rate
timeFrame: 6 months
measure: duration of hospitalisation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University
Study officials:
affiliation: Uşak University
name: Zelal Adibelli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00100464: Serotonin and the Upper Airway in Obstructive Sleep Apnea
Official title: Serotonin and the Upper Airway in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Serotonin
Sleep Apnea Syndrome
Pharyngeal Muscles
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2004-12-31
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a certain medication, alone or combined with another medication, will increase muscle activity in the upper airway in people who do and people who do not have sleep apnea. The medications being studied are paroxetine, a commonly used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary supplement without a prescription. Because the effects of paroxetine in previous studies were not very large, we will also study it combined with 5HTP to see if the effect on the upper airway muscles is greater.


Eligibility criteria: Group A: 20 Adult patients with mild to severe sleep apnea. If patients are being treated with nasal CPAP, they will continue treatment except on study nights.

Group B: 20 normal adult non-snoring subjects.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcolm Randall VA Medical Center
state: Florida
Study officials:
References:
Clinical trial NCT02515864: Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)
Official title: A Crossover Study to Assess the Effects of FYU-981 on the QT/QTc Interval in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Male and Female Volunteers
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.


Eligibility criteria: Inclusion Criteria:

* Japanese adult subjects
* Body mass index: \>=18.5 and \<27.5

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: QT/QTc Interval
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Japan
country: Japan
state: Kanagawa
Study officials:
References:
Clinical trial NCT02523664: Neural Correlates of Stress Hormones
Official title: Why Does Cortisol Enhance Memory Retrieval in Patients With Borderline Personality Disorder and Posttraumatic Stress Disorder? Investigating the Neuronal Correlates of Cortisol Administration and the Effects of Stress Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
PTSD
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate which neuronal correlates underlie cortisol-induced enhancement of memory retrieval in PTSD and BPD.

Detailed description: The investigators have recently shown that hydrocortisone enhances rather than impairs memory retrieval in patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD). In contrast, in healthy participants memory retrieval was impaired after hydrocortisone compared to placebo.

The proposed studies aim to further investigate these findings and to understand the underlying neuronal correlates. Thus, the mechanisms of enhanced memory retrieval after hydrocortisone in patients with BPD and PTSD will be investigated by fMRI.

In a placebo-controlled study, the effects of 10mg hydrocortisone on brain activity, in particular the hippocampus, will be investigated in patients with PTSD and BPD and will be compared with those in healthy control participants. During the fMRI session, a declarative memory task (retrieval of a previous learned word list) and an autobiographical memory test will be performed. Effects of hydrocortisone on resting state brain activity and the neuronal correlates of memory retrieval will be analysed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Borderline Personality Disorder
* Clinical diagnosis of PTSD
* females without psychiatric disorders as control group
* right handed

Exclusion Criteria:

* fMRI exclusion criteria e.g. metal implants, pregnancy, left-handedness, and claustrophobia.

Primary outcomes:
measure: brain activation after hydrocortisone
timeFrame: 20 min
Secondary outcomes:
measure: memory retrieval after hydrocortisone
timeFrame: 10 minutes
measure: memory retrieval after hydrocortisone
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT00285064: Assessment of Myocardial Viability Using Multidetector Computed Tomography
Official title: Non-Invasive Assessment of Myocardial Viability Using Multidetector Computed Tomography Post Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: MDCT
viability
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
First posted: 2006-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in patients with an acute ST elevation MI. In particular we plan to assess the relationship between regions with early hypoperfusion and/or late hyperenhancement, and myocardial viability.

Detailed description: 20 patients admitted to ICCU with ST elevation MI, and treated with primary angioplasty on admission, will undergo between day 2 and 7 post-MI the following exams: a) multidetector CT: regular scan plus late scan at 10 minutes, to evaluate coronary arteries, regional function and myocardial enhancement, b) echocardiography with echo-contrast to evaluate function and size of abnormally contracting region and remodeling, c) nuclear studies: rest early and late Thallium SPECT, to evaluate perfusion and viability. At 3 months a second echo will be performed to assess recovery of abnormal segments. The perfusion defects on MSCT will be compared with the other modalities and at 3 months will be used to evaluate recovery of myocardial function i.e. viability. Parameters that will be evaluated include opacity of hypoenhanced segments, ratio of normal to abnormal segments, change in opacity between early and late scans, size and transmurality of hypoenhanced segments, and their relation to regional contraction.

Eligibility criteria: Inclusion Criteria:

* acute ST elevation myocardial infarction
* after primary angioplasty

Exclusion Criteria:

* iodine allergy
* renal failure
* old MI
* arrhythmia
* inability to perform 20 second breath-hold

Primary outcomes:
measure: Prediction of viability from myocardial enhancement patterns
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Jonathan Lessick, MD DSc
role: PRINCIPAL_INVESTIGATOR
References: