louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05045625: Intraoperative Neuromonitoring Recording With a Novel SCS Paddle
Official title: Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Neuropathic Pain
Failed Back Surgery Syndrome
Complex Regional Pain Syndromes
Keywords: Spinal cord stimulation
chronic pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.


Eligibility criteria: Inclusion Criteria:

* patients undergoing a spinal cord stimulation procedure for neuropathic pain
* must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.
* subjects must be able to give informed consent.

Exclusion Criteria:

* patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 3 months
Secondary outcomes:
measure: McGill Pain Questionnaire (MPQ)
timeFrame: 3 month
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 3 months
measure: Beck Depression Index (BDI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT04216225: Pre-hospital Tourniquet in Extremity Injury
Official title: Prospective Observational Multi-center Analysis of Pre-hospital Tourniquet in Extremity Injury
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Extremity Injury
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons.

Brief summary: 2.1. Objective:

• Primary Objective: To compare outcomes of patients with extremity injuries presenting with or without pre-hospital tourniquet placement.

2.2. Study Outcome Measures

* Primary Outcome: Incidence of arrival in shock (SBP \<90)
* Secondary Outcomes: Demographics, comorbidities, mechanism of injury, cause of injury, diagnosis codes, procedure codes, Injury Severity Scale, Abbreviated Injury Scale, operative management vs. non-operative management, radiologic findings, pathologic findings, tourniquet effectiveness (as determined both subjectively by trauma surgeon and objectively by presence vs. absence of pulse below level of tourniquet application), total number of units of blood products transfused within first 24 hrs, total number of units of blood products for index admission, type of blood products or other fluid given, hospital length of stay, ICU length of stay, ventilator days, infectious complications, other complications, discharge disposition, 24 hr mortality, overall mortality.

Detailed description: This is a prospective, observational study. All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons. Data collected will include basic patient demographics, data regarding the patient's injuries, data regarding tourniquet use, and data regarding outcomes. Please see the attached data collection tool for specifics (Appendix 12.1). Data will be collected prospectively in an observational manner using the data collection tool. Data collected on individual collection sheets will be de-identified. We plan to complete the data collection and analysis by 01\\01\\2021.

Eligibility criteria: Inclusion Criteria:

≥ 18 y/o Patients with extremity injuries

* With a tourniquet in place OR
* Who the treating physician deems could have benefited from tourniquet placement

Exclusion Criteria:

* Children
* Prisoners
* Pregnant women
* Patients with non-traumatic bleeding requiring tourniquet use

Primary outcomes:
measure: Incidence of arrival in shock
timeFrame: First 24 hours .
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael Truitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00667225: Efficacy of Cantharidin in Molluscum Contagiosum
Official title: Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molluscum Contagiosum, Skin Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: Doris Duke Charitable Foundation
First posted: 2008-04-28
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.


Eligibility criteria: Inclusion Criteria:

* Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum.

Exclusion Criteria:

* Anyone with immunosuppression including HIV or previous organ transplantation.
* Anyone taking immunosuppressive medications.
* Anyone who has previously received treatment with cantharidin.
* Any female who has had her first menstrual period.

Primary outcomes:
measure: Patients Experiencing Complete Clearance of All Molluscum Lesions.
timeFrame: Baseline compared to 8 weeks (5 visits)
Secondary outcomes:
measure: Mean Change in Each Group Measured by Lesion Count.
timeFrame: Baseline compared to 8 weeks (5 visits)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC
name: Jacquelyn R Dosal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01717625: The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Official title: The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Birth
Infant, Very Low Birth Weight
Bronchopulmonary Dysplasia
Keywords: montelukast
BPD
singulair
prematurity
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Seoul National University Hospital
name: Gangnam Severance Hospital
name: Korea University
First posted: 2012-10-30
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is multicentered, prospective, randomized, opened, parallel, intervention study.

The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational age.

The investigators evaluate the first effectiveness through the morbidity and mortality of bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness through the oxygen index, the usage of mechanical ventilator about taking medicine after 2 Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial lavage fluid.


Eligibility criteria: Inclusion Criteria:

* Preterm infants born at less than 32 weeks
* Birth 14 days after, oxygen or artificial ventilation who are using patient
* more than 20cal/kg/d by enteral feeding
* written consent of the parents

Exclusion Criteria:

* congenital anomaly
* cardiovascular collapse
* investigator's opinion

Primary outcomes:
measure: Incidence of moderate to severe BPD or mortality
timeFrame: corrected gestational age
Secondary outcomes:
measure: Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event
timeFrame: 1, 2, 4 weeks since starting study
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university medical center
state: Woncheon-dong, Yeongtong-gu,
Study officials:
affiliation: Ajou University Medical Center
name: Moonsung Park, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04706325: COVID-19 RELATED KIDNEY DAMAGE
Official title: INVESTIGATION OF RISK FACTORS RELATED TO COVID-19 RELATED KIDNEY DAMAGE: A PROSPECTIVE OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Over 18 aged

* patients in ICU

Brief summary: In this study, we investigate whether the early detection of risk factors in Covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. We predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. In addition, we think that covid-19 patients may have positive contributions to shortening treatment time and reducing treatment costs. In addition, we are investigating whether it has a positive effect on patients' survival. In other words, we are investigating the contribution of risk factors to early diagnosis and treatment, the effect on health expenditures and mortality in patients with COVID-19 with acute kidney damage.


Eligibility criteria: Inclusion Criteria:

* Over 18 aged
* patients in ICU

Exclusion Criteria:

* Patients with known Chronic Renal Failure
* who have received dialysis treatment before
* who are under 18 years of age

Primary outcomes:
measure: KDIGO
timeFrame: 4 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Akif Şahin
Study officials:
affiliation: kocaeli derh
name: akif şahin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
citation: Aleebrahim-Dehkordi E, Reyhanian A, Saberianpour Sh, Hasanpour-Dehkordi A. Acute kidney injury in COVID-19; a review on current knowledge. J Nephropathol. 2020;9:e31. doi: 10.34172/jnp.2020.31
citation: Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
Clinical trial NCT01942525: Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
Official title: Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrauterine Growth Restriction
Premature - Weight 1000g-2499g or Gestation of 28-37weeks
Neurodevelopmental Disorder
EEG; Spikes, Centrotemporal, Epilepsy of Childhood
Keywords: IUGR
aEEG
preterm infants
neurodevelopmental outcome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 156
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospectively, children with intrauterine growth restriction (defined as a birth weight below the 10th percentile) treated at the Neonatal Intensive Care Unit (NICU) of the Medical University Vienna between 2005 and 2007 were included in the study. Besides IUGR, inclusion criteria were gestational age between 23+1 and 29+6 weeks and routinely assessed aEEG measurements. Infants with congenital anomalies and severe asphyxia were excluded. The control group consists of infants of the same age with normal birth weight (\>10th percentile) in the same study period.

Brief summary: Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.

Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.


Eligibility criteria: Inclusion Criteria:

* preterm infants below 30 weeks of gestation

Exclusion Criteria:

* congenital anomalies
* severe asphyxia

Primary outcomes:
measure: aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
timeFrame: first 14 days of life
Secondary outcomes:
measure: Neurodevelopmental outcome
timeFrame: 24 months
Other outcomes:
measure: Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls
timeFrame: 24 months
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Katrin Klebermass-Schrehof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02688725: Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients
Official title: Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.

Detailed description: The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims:

Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.

Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence.

Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.

Eligibility criteria: Inclusion Criteria:

* must be ≥ 18 years of age.
* histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer (American Joint Committee on Cancer, 7th edition stage 0, I, II, III, or IV) -previously treated with mastectomy

Exclusion Criteria:

* pregnant or breast feeding.
* cannot tolerate lying supine for breast ultrasound examination.
* mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive microcalcifications in the absence of concurrent DCIS or invasive breast cancer

Primary outcomes:
measure: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
timeFrame: 3 years
Secondary outcomes:
measure: The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured.
timeFrame: 3 years
Other outcomes:
Locations:
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
Study officials:
affiliation: Providence Health & Services
name: Steve Martinez, MD, MAS,FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06703125: The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya
Official title: The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Autism
HIV
Eye tracker
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-11-25
Enrollment: 850
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).

Detailed description: The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism outcomes. Investigators will recruit children enrolled in the Tabiri study during or following their 24-month visit.

The Tabiri study is comparing neurodevelopmental (ND) outcomes between 24-month-old CHEU and CHUU.

Eligibility criteria: Inclusion Criteria:

* Children enrolled in the Tabiri study (R01HD104552)
* CHEU or CHUU
* Children ages 24-72 months
* Caregivers of children must speak Kiswahili (local language) or English.

Exclusion Criteria:

* There will be no specific exclusion criteria. We anticipate that a small number of CHEU and CHUU will develop HIV prior to enrollment in the current study; these children will be included and will follow all general study procedures.

Primary outcomes:
measure: Agreement between eye-tracking biomarker score and autism diagnosis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
Study officials:
affiliation: IU School of Medicine
name: Rebecca McNally Keehn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05147025: Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization
Official title: Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Revascularization
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study will include 30 participants with failed revascularized young permenant teeth that will be retreated by revascularization and evaluated for success through 2 years


Eligibility criteria: Inclusion Criteria:

* central and lateral immature incisors
* child from 8- 10 years old
* healthy chidren
* failed revascularization

Exclusion Criteria:

* medically compromised children
* mentally compromised children

Primary outcomes:
measure: Root completion
timeFrame: 2 years
measure: Increase dentine thickness
timeFrame: 2 years
measure: Lesion healing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: