louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01591551: NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
Official title: NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Cornerstone Health Care, PA
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2012-05-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients receiving Natalizumab for 6 months relative to baseline.

Detailed description: Natalizumab has been shown to positively impact fatigue and cognition. The mechanism by which this occurs is unknown. Change in quality of sleep is one possible etiology of these findings. This study will help to elucidate the mechanisms that lead to reduced fatigue/sleepiness and less cognitive dysfunction in MS patients who go on Natalizumab therapy. Understanding these factors may help neurologists better differentiate between the different therapeutic options for MS and how they may impact symptoms that negatively affect quality of life.

Eligibility criteria: Inclusion Criteria:

* Relapsing form of multiple sclerosis
* Able to give informed consent and committed to follow the protocol
* EDSS from 0 to 6.0
* Epworth Sleepiness Scale \> 9 or Modified Fatigue Impact Scale \> 30 or Fatigue Severity Scale \> 4
* Age range of 18 - 65 years of age
* Naïve to Natalizumab
* Enrolled in the TOUCH program

Exclusion Criteria:

* Severe cognitive impairment
* Coexisting severe medical condition
* Inability to speak English or read
* Inability to give valid informed consent.

Primary outcomes:
measure: Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
timeFrame: Baseline and 6 months
measure: Change in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Patchogue
country: United States
facility: South Shore Neurologic Associates
state: New York
city: High Point
country: United States
facility: Cornerstone Neurology
state: North Carolina
city: Portland
country: United States
facility: Providence Brain Institute
state: Oregon
Study officials:
affiliation: Cornerstone Healthcare
name: Richard A Sater, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024251: BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
Official title: BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral and Maxillofacial Conditions
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After informed consent, eligible patients undergoing routine exams or elective oral and maxillofacial surgery will be enrolled for biological waste collection.

Brief summary: The BIO-MAX (BIOlogical waste sample collection for progress in oral and MAXillofacial research) study, led by IRCCS Ospedale Galeazzi-Sant'Ambrogio, is a five-year observational research project aimed at improving the understanding and treatment of oral and maxillofacial conditions.

Researchers are collecting and analyzing biological samples-such as saliva, blood, and tissues typically discarded during dental and surgical procedures-from adult patients visiting the hospital for oral exams or surgery. A key focus is the study of salivary irisin, a promising biomarker linked to diseases like diabetes and heart disease. By examining how irisin levels vary with age, gender, lifestyle, and oral health, the team hopes to establish baseline values and better understand its diagnostic potential.

In addition to irisin analysis, the study will explore other waste tissues to uncover disease mechanisms, identify new biomarkers, and test future therapies using patient-derived laboratory models. Overall, BIO-MAX seeks to enhance diagnostics, improve patient care, and pave the way for innovative treatments in oral and maxillofacial medicine.


Eligibility criteria: Inclusion Criteria:

* males and females
* ≥18 years old
* patients undergoing either routine oral clinical examination or elective oral and maxillofacial surgery at IRCCS Ospedale Galeazzi - Sant'Ambrogio

Exclusion Criteria:

* \<18 years old
* inability to sign the Informed Consent
* positivity to virological tests (HIV, HCV, HBV, TPHA), if serological analysis is required
* pregnancy and breast feeding with declaration of patient

Primary outcomes:
measure: Salivary Irisin Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
timeFrame: 5 years from first patient enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
References:
Clinical trial NCT00860951: P300 Brain Computer Interface Keyboard to Operate Assistive Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Amyotrophic Lateral Sclerosis
Neuromuscular Disease
Spinal Cord Injury
Cerebral Palsy
Keywords: Normal
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: U.S. Department of Education
First posted: 2009-03-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to develop tools enable people who are paralyzed to operate technology and access computers. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology.

Detailed description: The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology. The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a keyboard to let people operate these technologies without moving. However, the investigators need people to test the BCI so that the investigators can see how well it can replace a keyboard. The investigators want to understand how well it can work so that the investigators can make it useful for people who are paralyzed. The investigators will ask people to use the BCI to do things like make a communication system speak or type words on a computer.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation

Exclusion Criteria:

* Unable give informed consent.
* Unable to understand and follow instructions.
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
* Known to have photosensitive epilepsy.
* Open head lesions or sores

Primary outcomes:
measure: Accuracy of Typing With BCI Keyboard.
timeFrame: mean score from 3 sessions over 29 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Direct Brain Interface Project
state: Michigan
city: Albany
country: United States
facility: Wadsworth Center
state: New York
Study officials:
affiliation: University of Michigan
name: Jane Huggins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02016651: Positioning and Gastric Aspiration in Ventilated Premature Infants
Official title: Positioning and Gastric Aspiration in Ventilated Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Aspiration of Gastric Contents
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific marker for aspiration. The objective of this study is to examine if TA pepsin will change when ventilated premature infants are positioned in two different positions; on their back vs. on their right side.


Eligibility criteria: Inclusion Criteria:

* Infants born between 28 and 32 weeks gestational age
* postnatal age \> 72 hours
* tracheally intubated and receiving conventional mechanical ventilation
* feeding enterally more than 20 ml per day.

Exclusion Criteria:

* neurological insult in the form of perinatal asphyxia (pH \<7, base deficit more than 12, Apgar score at \< 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia
* major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis ,
* receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation

Primary outcomes:
measure: Pepsin concentration in tracheal aspirate
timeFrame: 6 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Children's Hospital
Study officials:
affiliation: Cairo University Children's Hospital
name: Reem Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farhath S, He Z, Nakhla T, Saslow J, Soundar S, Camacho J, Stahl G, Shaffer S, Mehta DI, Aghai ZH. Pepsin, a marker of gastric contents, is increased in tracheal aspirates from preterm infants who develop bronchopulmonary dysplasia. Pediatrics. 2008 Feb;121(2):e253-9. doi: 10.1542/peds.2007-0056.
citation: Aly H, Badawy M, El-Kholy A, Nabil R, Mohamed A. Randomized, controlled trial on tracheal colonization of ventilated infants: can gravity prevent ventilator-associated pneumonia? Pediatrics. 2008 Oct;122(4):770-4. doi: 10.1542/peds.2007-1826.
Clinical trial NCT05087251: The Transitions Project: Efficacy Trial
Official title: Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Supportive Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2021-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.

Detailed description: This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance.

In this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program.

It is expected that about 100 people will take part in this research study.

The American Lung Association is supporting this research by providing funding for the research study.

Eligibility criteria: Inclusion Criteria:

* Age 21 or older
* Able to read and respond in English
* Diagnosis of non-small cell lung cancer or small cell lung cancer
* Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery
* Completed cancer treatment within past 3 weeks

  * If final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete
  * If final treatment is surgery: within 3 weeks after hospital discharge following surgery

Exclusion Criteria:

* Comorbid health condition that would interfere with study participation
* Current participation in cognitive behavioral therapy treatment

Primary outcomes:
measure: Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
timeFrame: Up to 12 weeks
measure: Symptom burden: Edmonton Symptom Assessment Scale
timeFrame: Up to 12 weeks
measure: Psychological symptom burden: Hospital Anxiety and Depression Scale
timeFrame: Up to 12 weeks
measure: Social support: Multidimensional Scale of Perceived Social Support
timeFrame: Up to 12 weeks
measure: Social isolaton: Campaign to End Loneliness Measurement Tool
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lara Traeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05261451: Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
Official title: Effectiveness of Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: occupational therapy
trauma informed care
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will utilize a pre/post mix method design

Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops.

Qualitative data will be obtained through interviews post- workshop and consultations.


Eligibility criteria: Inclusion Criteria:

* Home Visitors or Teaching Staff at Head Start within San Bernardino County
* Between 18-65 years of age
* All genders
* English Speaking

Exclusion Criteria:

* NA

Primary outcomes:
measure: Post-Survey
timeFrame: Within 1 week after the consultations
Secondary outcomes:
measure: Interview
timeFrame: Within 2 weeks after the consultations
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
References:
Clinical trial NCT02790151: Memory Rehabilitation by Means of Working Memory Training in Combination With a Recollection Training
Official title: Memory Rehabilitation by Means of Working Memory Training in Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Deficits
Keywords: working memory, recollection training, transfer
Lead sponsor: University of Oldenburg
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Memory deficits after brain damage are common and there is still a need for evaluated therapy methods. In this study we compare two therapeutic interventions and investigate whether therapy effects can be found on neuropsychological tests and on a test measuring memory in everyday life.

Detailed description: In the interventiongroup a computerbased working memory training is combined with a recollection training (repitition-lag procedure). The patients in the active control group undergo the standard memory therapy that is normally provided in the rehabilitation centre (with a focus on the acquisition and execution of different memory strategies, e.g. the spaced retrieval method). The patients in both groups are tested on different neuropsychological tests before and after nine hours of therapy. Additionally, a test is conducted that assesses memory in everyday life.

Eligibility criteria: Inclusion Criteria:

* brain injury
* memory deficits (performance below average in the California Verbal Learning Test in learning trial 1 or 5, sfr or lfr)

Exclusion Criteria:

* severe amnesia (less than 2 words in sfr of the CVLT), dementia, sensory or motor aphasia, impaired vision, insufficient German language skills, lack of patient's consent

Primary outcomes:
measure: Test to assess change in memory performance in everyday life
timeFrame: baseline and 9 hours
Secondary outcomes:
measure: Outcome change in different neuropsychological tests
timeFrame: baseline and 9 hours
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Rehabilitationszentrum GmbH
state: Deutschland
Study officials:
affiliation: Universität Oldenburg
name: Helmut Hildebrandt, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Richter KM, Modden C, Eling P, Hildebrandt H. Improving everyday memory performance after acquired brain injury: An RCT on recollection and working memory training. Neuropsychology. 2018 Jul;32(5):586-596. doi: 10.1037/neu0000445. Epub 2018 Apr 26.
Clinical trial NCT04294251: Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
Official title: A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase Ⅲ Study to Evaluate the Efficacy and Safety of NABOTA® in Subjects With Benign Masseteric Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Masseteric Hypertrophy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 180
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: This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy


Eligibility criteria: Inclusion Criteria:

1. Male or female subject over 18 years of age and written informed consent is obtained.
2. Subject with Benign Masseter Hypertrophy.
3. Subject who has Bisymmetry of masseter at visual assessment.
4. Subjects who meets thickness of Masseter muscle by ultrasonography.
5. Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

1. Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
2. Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
3. Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
4. Subject with known hypersensitivity to botulinum toxin.
5. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
6. Subjects who are not eligible for this study at the discretion of the investigator.

Primary outcomes:
measure: Change from baseline in masseter muscle thickness
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in masseter muscle thickness
timeFrame: 24 weeks
measure: Change from baseline in lower face volume
timeFrame: 24 weeks
measure: Overall satisfaction of subject: questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
Study officials:
References:
Clinical trial NCT06961851: Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)
Official title: Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Major Depressive Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist.

The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years old
* Current patient of SLP Clinic
* Diagnosis of Unipolar Depression
* Have tried at least 1 antidepressant
* Ability to maintain stable medication regimen for duration of study

Exclusion Criteria:

* Has received TMS in the last 3 months
* Diagnosis of Bipolar Depression
* Any lifetime psychosis or mania
* Recent suicide attempt within 90 days of study visit
* Use of Benzodiazepines in past 4 weeks
* Presence of any contraindication to TMS assessed by the TMS Adult Safety Screen including individual history of uncontrolled seizures
* Current or history of alcohol abuse

Primary outcomes:
measure: Reduction in depressive symptoms
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Durability data of aTMS
timeFrame: 0, 1, 2, 4, and 6 weeks post treatment
measure: Dropout rate
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References: