louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05427565: Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study
Official title: Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Theta-Burst stimulation (iTBS)
Functional near-infrared spectroscopy (fNIRS)
Concurrent TMS/fNIRS
Prefrontal hemodynamic response
Longitudinal effects
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One healthy participant will undergo four weeks of concurrent TBS/fNIRS to investigate the cortical hemodynamic variability
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. The investigators will recruit a healthy participant and conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or without caffeine consumption before the stimulation. Moreover, the experiment will be conducted at different times of the day (morning or afternoon)

Detailed description: One healthy participant will be recruited for this study. The participants will be subjected to concurrent TBS/fNIRS, to which the iTBS will be applied on the left DLPFC and the NIRS will measure the prefrontal hemodynamic response simultaneously.

Eligibility criteria: Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* history of epilepsy, seizures, or convulsions
* current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
* current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
* with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker

Primary outcomes:
measure: Oxygenated hemoglobin (HbO) change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 1 month
Secondary outcomes:
measure: Deoxygenated hemoglobin (HbR) change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 1 month
measure: Oxygen saturation change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 1 month
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 S Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05947565: Patient Position and Invasive Urodynamic Study Results in Males
Official title: Will Performing Invasive Urodynamic Study in Sitting or Standing Position Effect the Results in Males?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Diagnosis
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to learn whether the change or patient position might effect the results of invasive urodynamic study in males.

Detailed description: Males will be randomised as Group 1 and Group 2. In Group 1, invasive urodynamic study will be performed first in sitting then repeated in standing position. In Group 2, invasive urodynamic study will be performed first in standing then repeated in sitting position. Results will be compared.

Eligibility criteria: Inclusion Criteria:

* Males over 18 years old and capable of standing during test

Exclusion Criteria:

* Patients not able to stand up during the test

Primary outcomes:
measure: Invasive urodynamic study
timeFrame: 1 day
measure: Invasive urodynamic study
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02940665: A Comparison of Protein Intake Between ERAS and Conventional Care After Elective Colorectal Surgery
Official title: Higher Protein Intakes Are Associated With Reduced Length of Stay: A Comparison Between ERAS and Conventional Care After Elective Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Disorders
Surgery
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for Dietetic Research (CFDR)
First posted: 2016-10-21
Enrollment: 115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal surgery

Brief summary: The primary objective of this prospective cohort study is to compare protein intake and adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with patients receiving conventional care. The study will also compare energy intakes, gut function, and clinical outcomes between groups. The ability of nutritional parameters, including preoperative malnutrition risk and postoperative protein intake, to predict length of hospital stay will be evaluated.


Eligibility criteria: Inclusion Criteria:

* adult patients ≥18 years of age
* elective colorectal resection

Exclusion Criteria:

* co-morbidities that could have interfered with oral intake (e.g., dysphagia)
* concurrent enteral or parenteral nutrition prior to surgery were excluded since food intakes could be influenced by these conditions.

Primary outcomes:
measure: Total protein intake (grams) as assessed by food records.
timeFrame: Average in first three postoperative days
Secondary outcomes:
measure: Length of hospital stay (number of days)
timeFrame: Number of days spent in hospital during admission for surgery up to 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3.
Clinical trial NCT05535465: Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities
Official title: Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: Institut Pierre Richet
name: Expertise France
First posted: 2022-09-10
Enrollment: 7500
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster randomized - Step-wedged design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In the REACT 2 project, a consortium proposes to study in Burkina Faso and Côte d'Ivoire, the impact of a public health intervention in rural communities in order to improve access to malaria therapeutic and preventive arsenal for vulnerable populations (i.e. children, adolescents and pregnant women). The intervention relies on the implementation of mobile health workers to support community health workers.


Eligibility criteria: Inclusion Criteria:

* global population

Exclusion Criteria:

* absence of informed consent

Primary outcomes:
measure: Difference of malaria incidence between control and intervention arms
timeFrame: Day 0 (cross-sectional survey)
Secondary outcomes:
measure: Difference of malaria prevalence between control and intervention arms
timeFrame: Day 0 (cross-sectional survey)
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: IRSS
state: Houet
city: Bouaké
country: Côte D'Ivoire
facility: IPR
Study officials:
References:
Clinical trial NCT04401865: Safety and Effectiveness of the PXL-Platinum 330 System
Official title: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Corneal Ectasia
Keratoconus
Pellucid Marginal Corneal Degeneration
Lead sponsor: Colorado Eye Consultants/Cornea Consultants of Colorado
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Detailed description: Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and pachymetry.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
4. Must be at least 8 years of age.
5. Non-consenting/impaired individuals with a LAR's signature

Exclusion Criteria:

1. Corneal thickness \< 300 microns measured by ultrasound or Pentacam.
2. Contraindications or sensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of Herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Current enrollment in another ophthalmic clinical trial.

Primary outcomes:
measure: Corrected distance visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Uncorrected visual acuity
timeFrame: 6 months
measure: Keratometry
timeFrame: 12 months
Other outcomes:
Locations:
city: Littleton
country: United States
facility: Colorado Eye Consultants/Corneal Consultants of Colorado
state: Colorado
city: Highland Park
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
Study officials:
affiliation: Colorado Eye Consultants/Corneal Consultants of Colorado
name: S. Lance Forstot, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485065: Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
Official title: A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome


Eligibility criteria: Inclusion Criteria:

1. MDS subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0\~1;
4. Not suitable for or refuse to receive HSCT;
5. Newly diagnosed MDS subjects;
6. Adequate organ function;
7. Subjects should take effective contraceptive measures
8. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

1. Subject who has transformed from MDS to AML.
2. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
3. MDS subjects with lower risk.
4. Subjects who have received chemotherapy.
5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
6. Subjects participating in another interventional clinical study.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 24 months
measure: Complete response rate (CR) and duration of complete response (DoCR)
timeFrame: 24 months
Secondary outcomes:
measure: Complete response rate (CR) and duration of complete response (DoCR)
timeFrame: 24 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Blood Diseases Hospital Chinese Academy Of Medical Science
Study officials:
References:
Clinical trial NCT01272765: Anti-psychotic Medication (Stable Dose) Weight Loss Study
Official title: Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months in Combination With 500 mg IHBG-10 TID
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obesity
Keywords: obesity
weight loss
weight management
anti-psychotic medication
Zyprexa
Seroquel
Risperdal
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-01-10
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: This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months.

Detailed description: A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are on a stable dose of Zyprexa). The investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. Subjects will continue to take their prescribed anti-psychotic medications. Participation in this study involves four study visits.

Eligibility criteria: Inclusion Criteria:

* Men and women, age 18 and older
* Agree to keep diet, exercise and all current health habits stable during participation in the study
* Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three months

Exclusion Criteria:

* Current active acute psychotic episode
* Women who are pregnant, breastfeeding, or planning to become pregnant
* Prior bariatric surgery
* Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
* Obesity as a result of a clinically-diagnosed endocrine problem

Primary outcomes:
measure: Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Edward Zawada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935465: Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation
Official title: Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic, Non-neuropathic Back Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-10-17
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching aim of this project is to conduct a randomized controlled study to determine whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.


Eligibility criteria: Inclusion Criteria:

1. age 21-60 years of age
2. English fluency
3. 20/20 vision with corrective lenses
4. current chronic, non-neuropathic back pain diagnosis determined by physician assessment
5. reporting pain ≥3 on 0-10 scale with opioid medication
6. current use of prescription opioids for ≥3 consecutive months
7. ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

1. Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
2. psychosis
3. untreated, active suicidality in the past month
4. and severe non-opioid substance use disorder in the past year as assessed with the MINI
5. clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
6. pregnancy
7. inability or unwillingness of individual to give written informed consent
8. physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.

Primary outcomes:
measure: Changes in endogenous opioid system function in response to pain challenge
timeFrame: Change from week 0 to 8 weeks
measure: Changes in fMRI activity level during natural reward processing
timeFrame: Change from week 0 to 8 weeks
Secondary outcomes:
measure: Pain sensitivity as a measure of volume of hypertonic saline
timeFrame: Change from week 0 to 8 weeks
measure: Self-report affect ratings
timeFrame: Change from week 0 to 8 weeks
measure: Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use
timeFrame: Change from week 0 to 8 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: College of Social Work
state: Utah
Study officials:
affiliation: The University of Utah
name: Eric L Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873465: Cannabis Use on Sedation for Oral Surgery Procedures
Official title: Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cannabis Use
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age
* Class I or II according to the American Society of Anesthesiology (ASA)
* Need for dental extractions
* Extraction procedures with similar level of complexity

Exclusion Criteria:

* Surgical time lesser than 10 or greater than 30 minutes
* ASA status of III or greater
* BMI greater than 30 k/m2
* Pregnancy
* Use of anti-depressants, sedatives, or other mood-altering medications
* History of illicit substance abuse, alcoholism, or chronic opioid use

Primary outcomes:
measure: Propofol dose in milligrams
timeFrame: During the procedure
Secondary outcomes:
measure: Heart rate in beats per minute
timeFrame: During the procedure
measure: Blood pressure in millimeters of mercury
timeFrame: During the procedure
measure: Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale
timeFrame: During the procedure
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: College of Dentistry
state: Oklahoma
Study officials:
References:
Clinical trial NCT03122665: Effectiveness of Nefopam for Thermoregulation During Surgery
Official title: Effectiveness of Nefopam for Thermoregulation During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: Nefopam
Pharmacokinetics
Shivering,
Thermoregulation
Anesthesia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Laboratoires Biocodex (Montrouge, France)
First posted: 2017-04-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Volunteers given two doses of nefopam in a crossover protocol.
Primary purpose: TREATMENT

Brief summary: Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

Detailed description: Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering.

Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.

Eligibility criteria: Inclusion Criteria:

* Normal healthy volunteers ages 18-40

Exclusion Criteria:

* history of alcohol or drug abuse

Primary outcomes:
measure: V1
timeFrame: three hours of infusion
measure: V2
timeFrame: three hours of infusion
measure: CLel
timeFrame: three hours of infusion
measure: CLdist
timeFrame: three hours of infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anesthesiology, University of Bern
state: Freiburgstrasses
Study officials:
References: