louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06809335: A Pilot of a Personalized Circadian MHealth to Improve Sleep in Night Shift Workers
Official title: A Pilot of a Personalized Circadian MHealth to Improve Sleep in Night Shift Workers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shift Work Sleep Disorder
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 300
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: The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.


Eligibility criteria: Inclusion Criteria:

* Inadequate sleep duration (habitual sleep less than 7 hours during the day)
* Willingness to download the SHIFT app and follow the lighting recommendations
* Ability to follow a set sleep schedule of 7 hours in bed after the night shifts
* Working at least 4 night shifts a month
* Shifts that must begin between 18:00 and 02:00 and last 8 to 12 hours
* Score of 8 or above on the Epworth Sleepiness scale and/or a score of 8 or above on the Insomnia Severity Index

Exclusion Criteria:

* Other independent sleep disorders (e.g., obstructive sleep apnea, narcolepsy, etc.)
* History of seizures or other significant neurological disorders
* Bipolar disorder
* Termination of shift schedule
* Pregnancy
* Current use of medications that impact sleep-wake functioning
* Alcohol and substance use disorder

Primary outcomes:
measure: Establish the effect of SHIFT on stakeholder-centered outcomes.
timeFrame: From enrollment to the 8 month point.
measure: Compare use experience and accuracy of SLEEP Android to the original iOS version.
timeFrame: From enrollment to the 8 month point.
Secondary outcomes:
measure: Assess facilitators and barriers to engagement and implementation.
timeFrame: Immediately following completion of 8-month treatment period.
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Columbus Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT01384435: A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official title: A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SCD
Keywords: Spinocerebellar degeneration (SCD)
Thyrotropin-Releasing Hormone (TRH)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).


Eligibility criteria: Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: Change from baseline in Scale for the assessment and rating of ataxia (SARA)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in patient improvement impression of activities of daily living
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Research Dept.
name: Katsumi Hontani
role: STUDY_DIRECTOR
References:
Clinical trial NCT02824835: Strigolactones and Dysplastic Colonic Lesions or Cancer
Official title: The Effect of the Plant Hormones Strigolactones on Cultures of Dysplastic Colonic Lesions and Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Neoplasms
Colonic Polyps
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure

Brief summary: The purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.

Detailed description: Strigolactones have been shown to anti-proliferative and pro-apoptotic effects in cell cultures of breast and prostate origin, partially by down-regulation of cyclin B1 and induction of cell cycle arrest. In this study the investigators intend to take biopsies from benign colonic polyps and cancer tissue, culture intestinal explants and generate immortalized primary cells as a platform to assess the effect of this plant hormone on cell viability, cell mobility, apoptosis and cytoskeleton modifications.

Eligibility criteria: Inclusion Criteria:

* Patients with positive findings during colonoscopy

Exclusion Criteria:

* Patients below 18 years old
* Patients who cannot sign a consent form

Primary outcomes:
measure: percentage of cells with reduced viability after dose-dependent exposure
timeFrame: 24 hours of exposure to strigolactone
measure: percentage of cells in G2/M arrest after dose-dependent exposure
timeFrame: 24 hours of exposure to strigolactone
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Ido Laish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayzlish-Gati E, Laufer D, Grivas CF, Shaknof J, Sananes A, Bier A, Ben-Harosh S, Belausov E, Johnson MD, Artuso E, Levi O, Genin O, Prandi C, Khalaila I, Pines M, Yarden RI, Kapulnik Y, Koltai H. Strigolactone analogs act as new anti-cancer agents in inhibition of breast cancer in xenograft model. Cancer Biol Ther. 2015;16(11):1682-8. doi: 10.1080/15384047.2015.1070982. Epub 2015 Jul 20.
citation: Pollock CB, Koltai H, Kapulnik Y, Prandi C, Yarden RI. Strigolactones: a novel class of phytohormones that inhibit the growth and survival of breast cancer cells and breast cancer stem-like enriched mammosphere cells. Breast Cancer Res Treat. 2012 Aug;134(3):1041-55. doi: 10.1007/s10549-012-1992-x. Epub 2012 Mar 29.
Clinical trial NCT00004335: Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Precocious Puberty
Keywords: endocrine disorders
growth hormone deficiency
hypogonadism
precocious puberty
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Michigan
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 7
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH) and sex steroid secretion in normal and hypogonadal children.

II. Examine the acute effects of sex steroids on the sleep-entrained patterns of GnRH secretion in pubertal children and normal adults, either by stimulation of endogenous production with pulsatile injection or by intravenous infusion of GnRH.

III. Examine the role of endogenous opioids by means of opioid receptor blockade in the sex steroid regulation of GnRH secretion in pubertal children and normal adults.

Detailed description: PROTOCOL OUTLINE: This project involves several clinical protocols that study the regulation and role of pulsatile gonadotropin-releasing hormone (GnRH) secretion.

Studies include dynamic and repeated stimulation tests of pulsatile GnRH; plasma luteinizing hormone, follicular-stimulating hormone, testosterone (T), estradiol (E2), and GnRH measurements at cyclic and episodic intervals; and evaluation of adrenal androgen patterns.

Circadian rhythms of GnRH secretion are monitored during sleep and awake hours. Growth hormone secretory patterns and responses to provocative stimuli are studied as clinically indicated.

Selected participants undergo an assessment of pituitary responsiveness following T, E2, and/or naloxone infusions. The suppressive effects of E2 are also studied during the early follicular phase of the menstrual cycle.

Endocrinologically normal children and normal adult men and women are also studied.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Suspected or proven hypothalamic-pituitary-gonadal dysfunction, i.e.: Significant short stature and possible hypopituitarism Delayed adolescence Precocious puberty Isolated growth hormone deficiency (IGHD)Primary hypogonadism
* Women are also studied, including those with the following disorders: Infertility Oligo- or amenorrhea Hirsutism

--Patient Characteristics--

* Age: 7 to 16 (18 to 35 for women and volunteers)
* Other: No pregnant or nursing women No prisoners Not in neuropsychiatric institute or other facility for mental illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: Carol M. Foster
role: STUDY_CHAIR
References:
Clinical trial NCT00826735: The Effect of Guided Imagery on the Third Stage of Labor
Official title: The Effect of Guided Imagery on the Third Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Stage of Labor
Bleeding
Guided Imagery
Childbirth
Keywords: third stage of labor
bleeding
guided imagery
childbirth
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International, Iota chapter
name: Sigma Theta Tau International, Delta Psi chapter
name: American College of Nurse-Midwive - ACNM Foundation
First posted: 2009-01-22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the effect of guided imagery on the third stage of labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is one of the leading causes of maternal mortality in the United States and the leading cause of maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would reduce the amount of bleeding during the third stage of labor.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older but less than 35 years
* English as her primary language
* fetus in a cephalic presentation
* singleton pregnancy
* 36 to 38 estimated gestational weeks
* no contraindications to vaginal delivery
* maternal weight less than 200 pounds prior to pregnancy

Exclusion Criteria:

* more than four previous children
* a history of postpartum hemorrhage
* bleeding disorder
* seizure disorder
* polyhydramnios
* diabetes (including gestational)
* hypertension
* cardiac disease
* uterine fibroids
* anemia (hematocrit less than 30)
* intrauterine fetal demise or tobacco use

Primary outcomes:
measure: Blood Loss
Secondary outcomes:
measure: Length of third stage of labor
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Nursing
name: Mavis N Schorn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04921735: An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.
Official title: An Observational Study of Cisatracurium 0.15 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (≥ 80 Years) Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Onset Time of Cisatracurium
Duration of Action of Cisatracurium
Intubation Conditions
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery

Brief summary: The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.

Detailed description: The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (\>80 years) has a longer onset time and duration of action compared to younger patients.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 80 or ≥18 - ≤40 years of age
2. Informed consent
3. Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia \> 1 hour) with intubation and use of cisatracurium
4. American Society of Anaesthesiologists (ASA) physical status classification I to III
5. Can read and understand Danish

Exclusion Criteria:

1. Known allergy to cisatracurium
2. Neuromuscular disease
3. Indication for rapid sequence induction
4. Surgery in the prone position

Primary outcomes:
measure: Onset time
timeFrame: within 10 minutes after administration
Secondary outcomes:
measure: Duration of action
timeFrame: within 120 minutes after administration of cisatracurium
measure: intubation conditions
timeFrame: within 10 minutes after administration of cistracurium
measure: intubation conditions
timeFrame: within 10 minutes after administration of cisatracurium
measure: Laryngeal morbidity
timeFrame: 24 hours after surgery
measure: Amount of ephedrine or metaoxedrine administered
timeFrame: within 10 minutes after administration of cisatracurium
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
citation: Vested M, Kristensen CM, Pape P, Vang M, Hartoft M, Hjelmdal C, Rasmussen LS. Comparison of onset time, duration of action, and intubating conditions after cisatracurium 0.15 mg/kg in young and elderly patients. BMC Anesthesiol. 2022 Nov 7;22(1):339. doi: 10.1186/s12871-022-01881-5.
Clinical trial NCT01515735: LOXL1 Polymorphism in Pseudoexfoliation Syndrome
Official title: Evaluation of LOXL1 Polymorphism in Pseudoexfoliation Syndrome in the Korean Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudoexfoliation Syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the groups or cohorts will be recruited from glaucoma clinic in Samsung medical center

Brief summary: To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene were analyzed by direct sequencing.

Detailed description: To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with pseudoexfoliation syndrome in the Korean population, peripheral blood sampling will be done from the patients with pseudoexfoliation.

And genotypes of the three single nucleotide polymorphisms of lysyl oxidase-like 1 gene , rs1048661, rs3825942, rs2165241 were analyzed by direct sequencing.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Pseudoexfoliation

Exclusion Criteria:

* medical condition that peripheral blood sampling cannot be done

Primary outcomes:
measure: Genotypes of the three single nucleotide polymorphisms of LOXL1 (rs1048661, rs3825942, rs2165241)
timeFrame: about 1 year (when all patients were recruited)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Changwon Kee, M.D., PhD
role: STUDY_CHAIR
References:
citation: Mori K, Imai K, Matsuda A, Ikeda Y, Naruse S, Hitora-Takeshita H, Nakano M, Taniguchi T, Omi N, Tashiro K, Kinoshita S. LOXL1 genetic polymorphisms are associated with exfoliation glaucoma in the Japanese population. Mol Vis. 2008 Jun 5;14:1037-40.
citation: Fuse N, Miyazawa A, Nakazawa T, Mengkegale M, Otomo T, Nishida K. Evaluation of LOXL1 polymorphisms in eyes with exfoliation glaucoma in Japanese. Mol Vis. 2008 Jul 21;14:1338-43.
Clinical trial NCT06016335: MRI-based Synthetic CT Images of the Head and Neck
Official title: Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Imaging of Bony Structures of the Head (Various Conditions)
Hearing Loss
Cholesteatoma
Sinusitis
Head and Neck Tumor
Keywords: MRI
Synthetic CT
Artificial Intelligence
Craniofacial
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: MRIguidance B.V.
First posted: 2023-08-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For all participants the same research activities will be performed (namely CT and MRI). The resulting paired MRI and CT scans will then be divided into a training set and a test set.
Primary purpose: DIAGNOSTIC

Brief summary: In case of surgical procedures in the head and neck region, MRI in combination with CT of the bone is often the standard modality to visualise bony landmarks for planning, navigation and risk assessment. An important downside of a CT scan is the associated radiation exposure, especially in children. An additional downside is the sedation or general anaesthesia needed for both the MRI and CT scan session in very young children. These downsides could be removed if the CT scan can be substituted by an MRI sequence that can provide the same information as CT. This project aims to determine the feasibility of recreating CT like images of the craniofacial bones from MRI images using machine learning techniques.


Eligibility criteria: Inclusion Criteria:

* Patients from the outpatient ENT (Ear, Nose, Throat)-clinic.
* Aged 18 years or older.
* Referred for CT scan of the mastoid, sinonasal complex or face.

Exclusion Criteria:

* Pregnancy.
* Contra-indications for MRI or CT.
* Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination.

Primary outcomes:
measure: Geometrical accuracy.
timeFrame: Within one year after scans have been obtained.
measure: Radiodensity accuracy.
timeFrame: Within one year after scans have been obtained.
measure: Visibility of landmarks.
timeFrame: Within one year after scans have been obtained.
Secondary outcomes:
measure: Usefulness.
timeFrame: Within one year after scans have been obtained.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Paul Merkus, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666535: Infliximab IBD Influenza Vaccine Study
Official title: Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: Influenza vaccine
Immune response
Remicade (infliximab)
Inflammatory bowel disease
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Janssen Inc.
First posted: 2012-08-16
Enrollment: 137
Sex: ALL
Minimum age (years): 9
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will compare the immunogenicity of influenza vaccine in adults and children with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab dosing. The primary objective is to compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase from pre to post-vaccination titer) to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBD established by accepted criteria
* On maintenance infliximab administered every 6 to 8 weeks (already received at least 6 weeks of infliximab)
* Between ages 9 and 60 years

Exclusion Criteria:

1. Pregnancy
2. Hypersensitivity reaction to previous dose of influenza vaccine
3. Known hypersensitivity to eggs or chicken or other components of influenza vaccine

Primary outcomes:
measure: Serologic protection
timeFrame: 28 days ± 3 days after influenza vaccination
Secondary outcomes:
measure: Immunogenic response
timeFrame: 28 days ± 3 days after influenza vaccination
Other outcomes:
measure: Number of participants with serious adverse events
timeFrame: 3 days post vaccination
measure: Change in disease activity from baseline
timeFrame: Four week post-vaccination
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jennifer deBruyn, MD
role: PRINCIPAL_INVESTIGATOR
References: