louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05199233: Mindfulness Intervention for Post-Covid Symptoms
Official title: The Benefit of Mindfulness-Based Intervention Using A Wearable Wellness Brain Sensing Device (Muse-S&#8482;) in the Treatment of Post-Covid Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Post Acute Sequelae of SARS-CoV-2
Keywords: Covid-19
PASC
Pandemic
Meditation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive and use the Muse S™ Headband system
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of using a wearable brain-sensing wellness device (Muse-S) to potentially reduce stress and anxiety during Post-Covid, which is characterized by increased stress and anxiety.

Detailed description: This study will answer the following questions: 1) will patients experiencing Long-Covid Syndrome utilize a wearable brain-sensing wellness device to potentially reduce stress and anxiety 2) does using this wearable brain-sensing wellness device help decrease stress and anxiety in patients who are experiencing Long-Covid Syndrome.

Eligibility criteria: Inclusion Criteria:

* Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester.
* Not pregnant by subject self-report at time of consent.
* Have the ability to provide informed consent.
* Have the ability to complete all aspects of this trial.
* Have access to an iPhone, iPad, or Android device.
* Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-SÔ system, as determined by the clinical investigators.

Exclusion Criteria:

* Used an investigational drug within the past 30 days.
* Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
* Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients' QOL, or stress.
* An unstable medical or mental health condition as determined by the physician investigator.

Primary outcomes:
measure: Change in Stress
timeFrame: 3 months post-baseline
measure: Change in Anxiety
timeFrame: 3 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ivana Croghan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Ryan Hurt, MD, PhD
role: STUDY_CHAIR
References:
citation: Hurt RT, Ganesh R, Schroeder DR, Hanson JL, Fokken SC, Overgaard JD, Bauer BA, Thilagar BP, Aakre CA, Pruthi S, Croghan IT. Using a Wearable Brain Activity Sensing Device in the Treatment of Long COVID Symptoms in an Open-Label Clinical Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251325639. doi: 10.1177/21501319251325639. Epub 2025 Mar 12.
Clinical trial NCT06105333: Fidgety Movements of Preterm Neonates Included in COSGOD III
Official title: Fidgety Movements of Preterm Neonates Included in COSGOD III - Ancillary Retrospective Observational Study to COSGOD III Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm
General Movements
Fidgety Movements
Near Infrared Spectroscopy
Neurological Outcome
Keywords: near-infrared spectroscopy
preterm neonates
preterm birth
cerebral injury
cerebral oxygenation
resuscitation
neurological outcome
fidgety movements
general movements
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 183
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm neonates \< 32 weeks of gestational age included in COSGOD III trial in Graz and Innsbruck are eligible to be included in this ancillary study.

Brief summary: The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain.

Two centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements).

Aim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge.

The investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.


Eligibility criteria: Inclusion Criteria:

* Preterm neonates included in the COSGOD III trial
* Death
* Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term

Exclusion Criteria:

* Neonates without FM analysis between six to 20 weeks post term

Primary outcomes:
measure: Short-term outcome
timeFrame: Between six to 20 weeks post term in surviving preterm neonates
Secondary outcomes:
measure: Interventions during resuscitation
timeFrame: First 15 minutes after birth
measure: Interventions during the first 24 hours after birth
timeFrame: First 24 hours after birth
measure: Neonatal morbidity at term age
timeFrame: Between birth and term age
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
Study officials:
affiliation: Division of Neonatology, Medical University of Graz, Austria
name: Gerhard Pichler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02467933: The Effect of Informative Letters on the Prescription and Receipt of Seroquel
Official title: The Effect of Informative Letters on the Prescription and Receipt of Seroquel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Economics
Fraud
Delivery of Health Care
Health Expenditures
Centers for Medicare and Medicaid Services (U.S.)
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: General Services Administration (GSA)
First posted: 2015-06-10
Enrollment: 5055
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the investigators will assess the effect of the letters on prescribing of Seroquel, receipt of Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes of patients.


Eligibility criteria: Inclusion Criteria:

* General care practitioner
* Outlier with respect to the count of Seroquel prescription drug treatments relative to peer group of prescribers in 2013 and 2014
* Outlier with respect to the count of Seroquel 30-day equivalent prescription drug treatments relative to peer group of prescribers in 2013 and 2014

Exclusion Criteria:

* Deceased

Primary outcomes:
measure: 30-day equivalent prescribing of Seroquel treatments
timeFrame: 9 months
Secondary outcomes:
measure: 30-day equivalent prescribing of Seroquel treatments
timeFrame: 3 months
measure: 30-day equivalent prescribing of Seroquel treatments
timeFrame: 6 months
measure: 30-day equivalent prescribing of Seroquel treatments
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Adam Sacarny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacarny A, Barnett ML, Le J, Tetkoski F, Yokum D, Agrawal S. Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):1003-1011. doi: 10.1001/jamapsychiatry.2018.1867.
Clinical trial NCT01232933: Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
Official title: Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Any Condition Requiring a PICC Placement
Keywords: PICC
Lead sponsor: VasoNova, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 83
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: Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.


Eligibility criteria: Inclusion Criteria:

* Adult with a PICC placement order

Exclusion Criteria:

* Pregnant or nursing
* Abnormal ECG
* Anatomic irregularities or history that would prevent proper placement
* Subject does not consent to photography, release of data and x-ray confirmation
* Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release

Primary outcomes:
measure: Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time
timeFrame: participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation
Secondary outcomes:
measure: The VPS will provide a blue bullseye indicator 80-90% of the time
timeFrame: participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT01396733: Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer
Official title: Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Thyroid
Cancer
Keywords: thyroid
cancer
redifferentiation
lipoic acid
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or metastatic of DTC with defective I-131 uptake.


Eligibility criteria: Inclusion Criteria:

1. aged 20 to 75 years
2. under birth control, if fertile women
3. Groups

   * who received radioactive iodine treatment for recurrent and metastatic thyroid cancer, and did not showed any uptake at post-therapeutic whole body scan
   * who planned to receive empirical radioactive treatment due to high expected recurrence

Exclusion Criteria:

* allergic to alpha-lipoic acid
* severe heart failure, lung disease, or end-stage renal disease
* liver function abnormalities (x2.5 above normal limits)
* neuropsychologically unstable patients
* previous history of drug medication such as oral steroid, digoxin, theophylline, carbamazepine, valproic acid, phenobarbital, methotrexate, cyclosporin, tacrolimus within 3 months before this recruitment.
* who is already taking alpha-lipoic acid for other purpose.

Primary outcomes:
measure: Increment of radioactive iodine uptake
timeFrame: 3months after alpha-lipoic acid treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01035333: A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
Official title: A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: gastric bypass surgery
Lead sponsor: Albany College of Pharmacy and Health Sciences
Sponsor class: OTHER
Collaborators: name: Albany Medical College
First posted: 2009-12-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.


Eligibility criteria: Inclusion Criteria:

* adult patients preparing for gastric bypass surgery

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Weight Loss
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany College of Pharmacy and Health Sciences
state: New York
Study officials:
affiliation: Albany College of Pharmacy and Health Sciences
name: Margaret Malone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05509933: Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Official title: Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Engraftment Syndrome
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 110
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: PREVENTION

Brief summary: The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.


Eligibility criteria: Inclusion Criteria:

* • Patients 18-80 years of age with a diagnosis of a hematological malignancy

  * Meet the BMT program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies

Exclusion Criteria:

* • Patients enrolled in investigational clinical trials

  * Sct for non hematologic malignancies

Primary outcomes:
measure: non-infectious fever
timeFrame: 30 days post stem cell transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT00300833: Treating Acute MI Patients With Aggrastat on Their Way to Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2006-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treating an AMI patient with ST elevation with Aggrastat in the ambulance on his or her way to the hospital.


Eligibility criteria: Inclusion Criteria:

patients with acute Myocardial infarction with ST elevation , and moving by ambulance to Poriya hospital

Exclusion Criteria:

* women less than 50 years old and 80 years old, bleeding tendency, stroke in the past

Primary outcomes:
measure: mortality
timeFrame: immidiately
Secondary outcomes:
measure: TIMI flow
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Cardiovascular Division, The Baruch Padeh Medical Center, Poriya,
city: Tiberias
country: Israel
facility: Magen David ,
Study officials:
affiliation: The Baruch Padeh Medicel Center, Poriya, Tiberias, Israel
name: Menachem Naheer
role: STUDY_CHAIR
References:
Clinical trial NCT04008433: Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides
Official title: Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lidocaine
Injection Pain
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 31
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: PREVENTION

Brief summary: Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. It is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.


Eligibility criteria: Inclusion Criteria:

* Ages ranged from 18 to 65.
* ASA Ⅰ or Ⅱ level.

Exclusion Criteria:

* Allergy or contraindication to lidocaine or propofol; required for Central venipuncture catheterization;
* Abnormal liver or kidney function;
* Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
* Hearing and language impairment;
* Peripheral vascular disease;
* Severe cardiovascular disease or neurological disorders;
* Failure of one-time peripheral venipuncture;
* Infection of hand or wrist skin.

Primary outcomes:
measure: The appearance of intravenous injection pain
timeFrame: through study completion, an average of 2 minutes
Secondary outcomes:
measure: The levels of intravenous injection pain
timeFrame: through study completion, an average of 2 minutes
measure: If any adverse memory or pain during the induction of general anesthesia
timeFrame: Before patients left the postanesthetic care unit (PACU)
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT03827733: Gut Microbiota and Alzheimer's Diseases
Official title: Gut Microbiota and Alzheimer's Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Keywords: Gut Microbiota
Alzheimer's Diseases
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly participants with normal congition will be collected from community. Alzheimer's disease participants and their spouse will be collected from Shanghai Tenth People's Hopital.

Brief summary: The investigator will perform clinical studies to test a hypothesis that participants who have Alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have Alzheimer's disease. The investigators will also check the microbiome of their partners in this study. The investigators plan to perform the studies in 150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai city. Investigators will also measure the beta-amyloid in the feces of the participants. Finally, the investigators will determine cognitive function in these participants.

Detailed description: Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with Alzheimer's disease (AD) neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of AD patients are different from those of the participants without AD and their partners. The investigators plan to recruit 150 subjects, including three groups of normal elders, AD patients and the partners of the AD patients. The cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations.

Eligibility criteria: Inclusion Criteria:

* aged 60 and older

Exclusion Criteria:

* with other acute gastrointestinal diseases
* with other severe neuropsychiatric disorders

Primary outcomes:
measure: Gut beta-amyloid 42
timeFrame: Through study completion, an average of 4 year
Secondary outcomes:
measure: Gut microbiota
timeFrame: Through study completion, an average of 4 year
measure: Oral microbiota
timeFrame: Through study completion, an average of 4 year
measure: Cognitive function by Mini-mental State Examination (MMSE)
timeFrame: through study completion, an average of 4 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yuan Shen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: