louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03194672: Healthy Adolescent Transitions (HAT)
Official title: Healthy Adolescent Transitions (HAT): A Comprehensive Approach to Targeting Adolescent Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy Prevention
Life Skill Development
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: OhioHealth Research and Innovation Institute
First posted: 2017-06-21
Enrollment: 331
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized trial of a rapid repeat pregnancy prevention program for adolescent mothers.

Five hundred adolescent mothers from central Ohio will be enrolled--half will be assigned to an intervention that features nurses and social workers providing extra assistance during late pregnancy and the early postnatal period and half will be assigned to a standard of care intervention.

OhioHealth is the lead entity. Nationwide Children's Hospital serves as the local independent evaluator.

This federally funded contract is supported by the Family and Youth Services Bureau.


Eligibility criteria: Inclusion Criteria (at baseline)

1. Age 14-19 years
2. 24-35 weeks gestation
3. Medicaid insurance
4. Central Ohio resident
5. English speaking
6. Ability to provide informed consent (18-19 years of age) or minor assent and parental consent (\<18 years of age)
7. Willingness to complete study-related surveys and coaching sessions
8. Patient must have her own smartphone, capable of running the study-related mobile application
9. Patient must have regular access to cellular or WiFi service

Exclusion Criteria

1. Patients \< 13 years or \>19 years
2. Non-English speaking
3. \<24 or \>35 weeks of gestation
4. Primary residence is located outside of central Ohio
5. Another adolescent from the household has already been enrolled in the program

Primary outcomes:
measure: Long acting reversible contraception
timeFrame: 12 months post enrollment
measure: Repeat pregnancy
timeFrame: 21 months post enrollment
Secondary outcomes:
measure: Nicotine use
timeFrame: 21 months post enrollment
measure: Financial literacy
timeFrame: 21 months post enrollment
measure: School completion
timeFrame: 21 months post enrollment
measure: Medical home
timeFrame: 21 months post enrollment
measure: Healthy eating behaviors
timeFrame: 21 months post enrollment
measure: Employment
timeFrame: 21 months post enrollment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Innovation Institute
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jack Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stevens J, Rausch J, Osuagwu N, Lutz R. Efficacy of Behavioral Economic Nudges to Assist Teen Mothers: the Healthy Adolescent Transitions Randomized Controlled Trial. Prev Sci. 2024 Apr;25(3):509-520. doi: 10.1007/s11121-024-01660-3. Epub 2024 Mar 2.
Clinical trial NCT00603772: Clinical Evaluation of the Photoallergy Potential of Atralin Gel
Official title: Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Tretinoin
exposure to UV light
phototoxicity
Safety when exposed to sunlight
Lead sponsor: Coria Laboratories, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.


Eligibility criteria: Inclusion Criteria:

* Normal, healthy volunteers
* 18 years of age and older

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: UV Induced skin irritation
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Suncare Research Laboratories
state: North Carolina
Study officials:
affiliation: Suncare Research Laboratories
name: Joseph W Stanfield, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04162704: EpiCheck and Short-term Intensive Chemoresection in NMIBC
Official title: EpiCheck and Short-term Intensive Chemoresection in NMIBC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection

Brief summary: The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.

Detailed description: The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.

Eligibility criteria: Inclusion Criteria:

* Patients with a known history of Ta HG with recurrent disease
* Patients referred to short-term, intensive chemoresection
* Patients older than 18 years

Exclusion Criteria:

* Known allergy or intolerance to Mitomycin
* Incontinence or small bladder capacity (\< 100 mL)
* Previous pelvic radiation therapy

Primary outcomes:
measure: EpiCheck result
timeFrame: One to two months after short-term, intensive chemoresection
Secondary outcomes:
measure: EpiCheck result 2
timeFrame: One to two months after short-term, intensive chemoresection
measure: EpiCheck result 3
timeFrame: One to two months after short-term, intensive chemoresection
measure: Urine cytology
timeFrame: One to two months after short-term, intensive chemoresection
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT04010604: A Registered Cohort Study on SMA
Official title: A Registered Cohort Study on Spinal Muscular Atrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Muscular Atrophy
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SMA patients are diagnosed with SMN1 gene deletion or mutation.

Brief summary: Spinal muscular atrophy (SMA) is an autosomal recessive disease that causes progressive muscle wasting and weakness due to loss of motor neurons in the spinal cord. This is a registered cohort of spinal muscular atrophy (SMA) type I，II and III in China. This study will provide further insights into the clinical course of SMA including overall survival, demographic characteristics, motor function, respiratory support, feeding and nutritional support, growth and development. The correlation of genotype and phenotype will be conducted.


Eligibility criteria: Inclusion Criteria:

* Patients with SMA types I, II and III
* Asymptomatic SMA carriers
* Relatives of SMA patients or carriers
* Unrelated healthy controls
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

\* Participants are unable to comply with trial procedures and visit schedule

Primary outcomes:
measure: The time to death
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 20years
measure: The correlation of genotype and phenotype
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 20years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology, First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT06142604: Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery
Official title: Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Surgery
Keywords: Flecainide
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2023-11-21
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: Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.

Detailed description: FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Noncardiac surgery in the last 30 days requiring an overnight hospital admission;
* Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;
* In AF at the time of randomization; AND,
* Provided written informed consent.

Exclusion Criteria:

* History of AF without normal sinus rhythm documented within 90 days prior to randomization;
* Hemodynamic instability;
* Have any one of the following contraindications to flecainide:

  1. known left ventricular ejection fraction ≤ 40%;
  2. myocardial infarction within the last 30 days;
  3. QRS interval \>140ms;
  4. allergy to flecainide;
  5. severe uncorrected hypokalemia (\<2.5 mEq/L) or hyperkalemia (\>6.5 mEq/L) at the time of randomization;
  6. severe acute liver dysfunction or history of advanced cirrhosis;
  7. severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
  8. second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;
* Unable to take oral medication;
* Previously enrolled in the trial.

Primary outcomes:
measure: Recruitment rate
timeFrame: through study completion, an average of six months
measure: Follow-up completion rate
timeFrame: through study completion, an average of six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06411704: Remote Exercise Video Adaptations to Maximize Physical Activity in Childhood Cancer
Official title: Remote Exercise Video Adaptations to Maximize Physical Activity in Childhood Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Survivorship
Childhood Cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term childhood cancer survivors with low physical activity.

Brief summary: The goal of this observational study is to leverage childhood cancer survivor input to adapt video content of a digital video disc-(DVD) delivered evidence-based PA intervention, originally designed for community-dwelling older adults.

Primary Objective:

- To leverage childhood cancer survivor input to adapt video content for an evidence-based remote exercise intervention.

Detailed description: This study is being done to update existing exercise videos to suit adult survivors of childhood cancer to help them exercise at home. Patients will be asked to watch exercise videos designed for older adults and provide feedback during an interview to help researchers update the videos to childhood cancer survivors' preferences

Eligibility criteria: Inclusion Criteria:

* Participants enrolled in the St. Jude Lifetime Cohort (SJLIFE), aged 18- 39.
* Identifies as low active (self-reports \<2 days/week of Physical Activity (PA) for at least 30 minutes over the past 6 months.
* Participant or legal guardian is able and willing to give informed consent.
* Internet access

Exclusion Criteria:

* Individuals who cannot speak, read, and/or understand English.

Primary outcomes:
measure: Qualitative interviews
timeFrame: Day 1
measure: System Usability Scale Questionnaire
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kristen Ness, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01835704: Health-economic Evaulation of Interventional Pain Mangement
Official title: Health-economic Evaluation of Interventional Pain Management Among Patients With Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Eques Indolor AB
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 1540
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pain of more then 6 months duration

Brief summary: To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.


Eligibility criteria: Inclusion Criteria:

* All patients

Exclusion Criteria:

Primary outcomes:
measure: Quality Adjusted Life gained
timeFrame: 1 year
Secondary outcomes:
measure: Cost per QALY gained
timeFrame: 1 year
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Smärtkliniken i Umeå
Study officials:
name: Johan Hambraeus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hambraeus J, Pulkki-Brannstrom AM, Lindholm L. Cost-effectiveness of Radiofrequency Denervation for Zygapophyseal Joint Pain. Pain Physician. 2021 Dec;24(8):E1205-E1218.
Clinical trial NCT03706404: Renal Colic Fast Track Pathway in the Emergency Department.
Official title: Randomised Controlled Trial to Assess a Renal Colic Fast Track Pathway in the Emergency Department Using Point-of-care Ultrasound and Point-of-care Testing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Colic
Keywords: Renal Colic
Point-of-Care ultrasound
Point-of-Care testing
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Validation of a high-resolution, fast track pathway that combines the use of laboratory tests at the Point-of-Care Testing (POCT) and Point-of-Care ultrasound (POCUS) versus the classical pathway, in which blood samples are sent to the central laboratory and comprehensive radiological exams ordered, being equally effective, at a lower cost of care and time of stay in the emergency department.


Eligibility criteria: Inclusion Criteria:

* First renal colic episode
* Need of analgesia
* Oral tolerance

Exclusion Criteria:

* Hemodynamic instability
* Fever
* Anuria
* Abdominal trauma
* Chronic renal failure
* Active oncologic disease
* Kidney transplant or monorenal patient

Primary outcomes:
measure: Length of stay in the Emergency Department
timeFrame: 24 hours
measure: Adverse events
timeFrame: 30 days
Secondary outcomes:
measure: Number of conclusive exams in the Point-of-Care intervention arm.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
citation: Tung Chen Y, Rodriguez Fuertes P, Oliver Saez P, Villen Villegas T, Buno Soto A, Fernandez Calle P, Carballo Cardona C, Cobo Mora J, Jaen Canadas M, Yan Tong H, M Borobia A. Efficacy of a fast-track pathway for managing uncomplicated renal or ureteral colic in a hospital emergency department: the STONE randomized clinical trial of Sonography and Testing of a Nephrolithiasis Episode. Emergencias. 2021 Feb;33(1):23-28. English, Spanish.
Clinical trial NCT00095004: Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)
Official title: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-11-01
Enrollment: 167
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 purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.


Eligibility criteria: Inclusion Criteria:

* Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.

Exclusion Criteria:

* Heart disease
* High blood pressure

Primary outcomes:
measure: Percentage of patients who are pain free at 2 hours postdose
measure: Tolerability as measured by subjective adverse experience reporting
Secondary outcomes:
measure: Percentage of patients with 24 hour sustained pain freedom
measure: Percentage of patients pain free at 30/45/60/90 minutes post dose
measure: Percentage of patients with associated symptoms at 2 hours
measure: Percentage of patients requiring rescue medication between 2 & 24 hours
measure: Percentage of patients with functional disability at 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24. doi: 10.1111/j.1526-4610.2006.00466.x.
citation: Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13.
citation: Cady R, Martin V, Mauskop A, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. doi: 10.1111/j.1468-2982.2007.01391.x. Epub 2007 Aug 6.
citation: Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
Clinical trial NCT00179504: The Effect of Relaxation Response Training on Declarative Memory and Learning in High School Students
Official title: The Effect of Relaxation Response Training on Declarative Memory and Learning in High School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.

Detailed description: Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.

Eligibility criteria: Inclusion Criteria:

* a member of 9th grade at a residential preparatory school.

Exclusion Criteria:

* none

Primary outcomes:
measure: Determine if a 6-week relaxation response (RR) curriculum improves cognitive performance.
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluate whether the program would influence levels of salivary cortisol and whether there would be a correlation between cortisol levels and performance on the cognitive tasks.
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Mind/Body Medical Institute
name: Jeffery A Dusek, PhD
role: PRINCIPAL_INVESTIGATOR
References: