louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04874493: Patient Reported Outcome Post Radiation Therapy or Chemoradiotherapy Patient Care in Patients With Oropharyngeal Cancer
Official title: A Pilot Study to Define PROs for Establishing a Pathway for Post Radiation or Concurrent Chemo Radiation (RT/CRT) Patient Care for Oropharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Oropharyngeal Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with OPC who were seen for new patient evaluation at clinics and head and neck cancer (HNC) centers at MD Anderson Cancer Center

Brief summary: This study examines patient reported outcomes post radiation therapy or chemoradiotherapy patient care in patients with oropharyngeal cancer. This study may help researchers learn about the symptoms that patients with oropharyngeal cancer have after completing radiation therapy.

Detailed description: PRIMARY OBJECTIVE:

I. To provide evidence of clinically relevant symptoms for integrating into a user-friendly, automated pathway for real-time tracking and management of symptoms during post radiation therapy (RT)/chemoradiation (CRT) for oropharyngeal cancer (OPC).

OUTLINE:

Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Patients who were seen for new patient evaluation at clinics and HNC centers at MD Anderson Cancer Center
* Adult patients with OPC (\> 18 years old) who have been enrolled under PA14-0947

Primary outcomes:
measure: Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities
timeFrame: From the end of radiation therapy (RT)/chemoradiotherapy (CRT) treatment to 2 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Xin S Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854893: Enhance of Language Learning with Neurostimulation
Official title: Enhance of Language Learning with Neurostimulation (transcranial Direct Current Stimulation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Aging
Keywords: stroke
aphasia
aging
language learning
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2009-03-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of transcranial direct current stimulation over the motor cortex of the language dominant hemisphere on language learning in healthy subjects and stroke patients with aphasia. We hypothesize that anodal stimulation enhances the learning of action words compared to sham and cathodal stimulation.

Detailed description: The motor cortex is involved at different levels of language processing. It has been demonstrated that the perception of action words activates motor representations in the language-dominant hemisphere. However, it is not known whether modulation of excitability has an effect on learning new action words. Thus, we hypothesize that transcranial direct current stimulation over the motor cortex of the language-dominant hemiphere modulates the acquisition of new action words. The results bear the potential to design new rehabilitative strategies in stroke patients with aphasia. The motor cortex might offer an access to the language network that can be used for interventional approaches such as neurostimulation.

Eligibility criteria: Inclusion Criteria:

* age \>18 and \< 86 years
* contractual capability
* ischemic stroke excluding motor cortex (stroke patients)
* minimum time since stroke 9 months
* aphasia (stroke patients)
* severe aphasia that impedes understanding of instructions (stroke patients)

Exclusion Criteria:

* sever head trauma in the past
* seizures
* pace maker
* metal implants in the head/neck region
* severe comorbidity, especially neurologic and psychiatric diseases
* intake of illegal drugs
* Mini Mental State examination score \< 27
* neuroactive substances, e.g. antidepressants
* pregnancy

Primary outcomes:
measure: word learning
timeFrame: immediately after intervention and after 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf, Department of Neurology
state: HH
Study officials:
affiliation: Universitätskrankenhaus Hamburg-Eppendorf
name: Gianpiero Liuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branscheidt M, Hoppe J, Freundlieb N, Zwitserlood P, Liuzzi G. tDCS Over the Motor Cortex Shows Differential Effects on Action and Object Words in Associative Word Learning in Healthy Aging. Front Aging Neurosci. 2017 May 15;9:137. doi: 10.3389/fnagi.2017.00137. eCollection 2017.
Clinical trial NCT06938893: Study on Cardiac Output Evaluation Based on Wearable Monitoring Data
Official title: Study on Cardiac Output Evaluation Based on Wearable Monitoring Data
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Output
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred HF patients with an left ventricular ejection fraction (LVEF) of less than 50% and 100 normal cardiac function subjects with an LVEF of 50% or greater were enrolled

Brief summary: Based on the monitoring data of wearable devices, with cardiac output (CO) as the gold standard, this study intends to develop a non-invasive evaluation model of CO based on wearable data, and optimize the parameters to realize the cardiac capacity detection function in resting and exercise states on the wearable device.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) \< 50%(200 subjects)
* Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) ≥50% (100 subjects)
* Able to use smart phones and operate wearable devices such as wristbands/watches

Exclusion Criteria:

* Patients with pacemaker implantation
* No smartphone
* Currently participating in other clinical trials
* Lactating women
* Pregnant Women
* Unable to run and ride due to personal physical and external reasons (subjects participating in the exercise state cardiac output model study)
* Physical examination results in the past year have clear cardiovascular, metabolic, bone and joint related diseases that have exercise risk, or have diseases and related potential health risks confirmed by the self-examination form of physical status before exercise (participants in the exercise state cardiac output model study)
* No informed consent was obtained

Primary outcomes:
measure: cardiac output
timeFrame: From enrollment to the end of follow-up at 1 month
Secondary outcomes:
measure: Heart failure
timeFrame: From enrollment to the end of follow-up at 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04215393: An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization
Official title: An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Corneal Neovascularization
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization.

The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.


Eligibility criteria: Inclusion Criteria:

* Signed the informed consent form, volunteered to participate in the trial and followed up according to the protocol.
* Ages from 18 to 75,male or female.
* Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.

Exclusion Criteria:

* Subjects who had significant defect in the corneal epithelium.
* Study eye had been injected of anti-vegf drugs within 3 months before screening
* Study eye was performed surgery (except keratoplasty) within 3 months prior screening, or eye surgery was planned during this trial period.
* Oral glucocorticoid administration within 1 month prior screening (except for duration less than 7 days)
* Systemic use of anti-vegf drugs within 45 days prior to screening.
* Have history of abnormal coagulation, such as end-stage liver disease, or are taking anticoagulants（except aspirin）.
* Uncontrolled clinical problems such as canner etc..
* Unable or unwilling to use effective contraception.
* Positive blood tests for pregnancy (female subjects)
* Participated in drug clinical trials within 3 months before the first administration.
* The researchers think the participants were not suitable for this trail.

Primary outcomes:
measure: Ocular and Systemic Safety: occurrence of ocular and systemic adverse events
timeFrame: day 14
Secondary outcomes:
measure: The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study
timeFrame: day 14 and day 28
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03470493: ApneaLink Air Home Sleep Testing (HST) Device Validation Study
Official title: Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-disordered Breathing
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.

Detailed description: The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.

The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.

Eligibility criteria: Inclusion Criteria:

* Participant is 18 years of age or older
* Participant is willing to provide informed consent
* Participant is willing to participate in all study related procedures

Exclusion Criteria:

* Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)
* Requires use of oxygen therapy during sleep
* Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)
* Pregnant
* Participant is unsuitable to participate in the study in the opinion of the investigator

Primary outcomes:
measure: Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)
timeFrame: Day 1
Secondary outcomes:
measure: Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events
timeFrame: Day 1
measure: Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG
timeFrame: Day 1
measure: Positive Likelihood Ratio of Apnealink Air
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Florida
name: Richard Berry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188793: Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients
Official title: Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Virtual reality
Inpatient
Pain
Brain Gut Behavioral Treatment
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting.

The study hypothesizes that:

* At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program
* Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.


Eligibility criteria: Inclusion Criteria:

* Patients with Inflammatory Bowel Disease and self-reported pain
* Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria:

* Patients that do not report pain
* Anticipated length of hospital stay is less than 72 hours
* Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
* Patients with binocular vision loss
* Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease.
* Patients that are currently pregnant

Primary outcomes:
measure: Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program
timeFrame: 3 days of treatment
Secondary outcomes:
measure: Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview
timeFrame: 1 week (semi-structured interview within 1 week of completion of the intervention)
measure: Acceptability using the System Usability Scale - patients
timeFrame: Day 3 (post intervention)
measure: Acceptability using the Treatment Acceptance and Adherence Scale- patients
timeFrame: Day 3 (post intervention)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Shirley Cohen-Mekelburg, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04149093: The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease
Official title: The Association Between Calretinin and the Function of Ganglion Cells in Long Segment and Total Hirschsprung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hirschsprung Disease
Ganglion
Hirschsprung Disease, Long-Segment
Hypoganglionosis
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hirschsprung disease and a transition zone more proximal to the distal sigmoid

Brief summary: This study aims to compare the outcomes of patients with long segment Hirschsprung disease or total colonic aganglionosis who had negative calretinin staining and positive ganglion cells on the proximal resection margins to those who had both positive findings.


Eligibility criteria: Inclusion Criteria:

* Confirmed histopathological diagnosis of Hirschsprung disease from January 1, 1990 to August 31, 2019
* Long-segment Hirschsprung disease (type A and B)
* Total colonic aganglionosis (TCA)
* Surgery at CHUSJ
* Tissue blocks of proximal resection margin available for pathological analysis
* Minimum 1 month of postoperative follow-up

Exclusion Criteria:

* Short-segment Hirschsprung disease (conventional form, rectosigmoid junction)
* Total colonic with small bowel aganglionosis (TCSA)
* Surgery done at another institution
* Early deaths
* Lost to follow-up
* No documented post-operative outcome

Primary outcomes:
measure: Long-term outcomes (Quality of life questionnaire)
timeFrame: 1 year
Secondary outcomes:
measure: Surgical complications
timeFrame: 1 year
measure: Functional outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT03054493: Prevalence of NNSH in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.
Official title: Prevalence of Non-Nutritive Sucking Habits in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Behavior
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 1023
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A group of Egyptian children aged 3-8 years in Giza Governorate.

Brief summary: 1. Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged 3-8 years old in Giza Governorate.
2. Assessment of factors associated with NNSH.

Detailed description: Several studies have reported on the prevalence of non-nutritive sucking behaviors among infants and young children in different populations. Non-nutritive sucking is regarded as a normal part of development, and early studies of its prevalence generally found that 70-90% of children had some history of a non-nutritive sucking habit. Like these early studies, most recent studies have used retrospective methods to assess the prevalence of non-nutritive sucking habits.

Prolonged duration of non-nutritive sucking behaviors may have consequences in regard to the developing orofacial structures and occlusion. Little is known as to why some children have sucking habits beyond the first 2 to 3 years of life.

Prevalence of NNSH and associated factors in Egyptian children might be different.

Eligibility criteria: Inclusion Criteria:

* 3-8 years old children.
* Children free of systemic diseases.
* Positive patient/parents acceptance for participation in the study.
* Both sexes will be included.

Exclusion Criteria:

* Disabled children.
* Children with cleft lip \& palate.
* TMJ disorders.
* Children undergoing orthodontic/orthopedic treatment.
* Participants who were exposed to thumb sucking prevention programs.

Primary outcomes:
measure: non-nutritive sucking habits
timeFrame: 20 mins
Secondary outcomes:
Other outcomes:
Locations:
city: October 6
country: Egypt
facility: Afnan Mohammad Nassar
Study officials:
affiliation: Cairo University
name: Afnan Mo Nassar, Bechlor
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Holanda AL, dos Santos SA, Fernandes de Sena M, Ferreira MA. Relationship between breast- and bottle-feeding and non-nutritive sucking habits. Oral Health Prev Dent. 2009;7(4):331-7.
citation: Maia-Nader M, Silva de Araujo Figueiredo C, Pinheiro de Figueiredo F, Moura da Silva AA, Thomaz EB, Saraiva MC, Barbieri MA, Bettiol H. Factors associated with prolonged non-nutritive sucking habits in two cohorts of Brazilian children. BMC Public Health. 2014 Jul 22;14:743. doi: 10.1186/1471-2458-14-743.
citation: Medeiros AP, Ferreira JT, Felicio CM. Correlation between feeding methods, non-nutritive sucking and orofacial behaviors. Pro Fono. 2009 Oct-Dec;21(4):315-9. doi: 10.1590/s0104-56872009000400009.
Clinical trial NCT01138293: Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Keywords: differences between patients´ self-assessment and objective perception of physical activity and eating habits
Lead sponsor: MEDIGREIF Inselklinik Heringsdorf
Sponsor class: NETWORK
Collaborators: name: Fraunhofer Institut für Graphische Datenverarbeitung (IGD), Rostock, Germany
First posted: 2010-06-07
Enrollment: 73
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. The present trial aims to integrate telemedical support in therapy to improve long term outcome.

Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index \[BMI\] 31.2±5.4kg/m², body mass index standard deviation score \[BMI-SDS\] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.


Eligibility criteria: Inclusion Criteria:

* All children/adolescents with overweight/obesity were included admitted to our hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heringsdorf
country: Germany
facility: MEDIGREIF Inselklinik Heringsdorf GmbH, Haus Gothensee
Study officials:
References: