louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04043897: Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Official title: Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Microscopic Colitis
Keywords: Microscopic Colitis
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with a diagnosis of microscopic colitis will receive open-label rifaximin 550mg tid x 4 weeks.
Primary purpose: TREATMENT

Brief summary: This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.

Detailed description: This is an open-label single-arm trial to evaluate the efficacy of Rifaximin in patients with active microscopic colitis (MC). 10 subjects will be asked to take 500mg Rifaximin three times per day for 4 weeks. The primary endpoints will be histologic response and clinical remission (less than 3 stools per day and less than 1 watery stool per day within the prior 7 days. The secondary endpoint will be change of the MC Disease Activity Index (MCDAI).

Eligibility criteria: Inclusion Criteria:

* Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists
* CC will be defined histologically to be the following: thickness of the collagenous subepithelial table \>10 micrometer using an ocular micrometer, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, lack of crypt architectural distortion, and regenerative-appearing changes in the surface and/or crypt epithelium
* LC will be defined histologically to be the following: intraepithelial lymphocytes \>20 per 100 epithelial cells in the subjective area of highest lymphocyte density, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, and regenerative-appearing changes in the surface and/or crypt epithelium
* Subjects in active flare, defined as \>3 watery/loose stools per day on \>4 / 7 days over \>4 weeks in the past 3 months.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Subject Experiencing Remission of MC Symptoms
timeFrame: 6 weeks
measure: Histologic Response for Indications of Disease Severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Change of the MC Disease Activity Index (MCDAI)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Eugene Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02877797: Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla
Official title: The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visualisation and Evaluation of Ampulla of Vater
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.


Eligibility criteria: Inclusion Criteria:

* Indication of Esophagogastroduodenoscopy independent from the study
* Written informed
* Age ≥ 18 years

Exclusion Criteria:

* Absence of written informed consent
* Contraindication or absence of informed consent regarding sedation with Propofol
* Postoperativ changes of the upper GI-tract
* Intention of endoscopic intervention
* Suspicion of upper GI-bleeding
* Suspicion of stenosis of the esophagus
* Stent in the papilla duodeni major
* ASA (American Society of Anesthesiologists) classification ≥ 3

Primary outcomes:
measure: Rate of complete visualisation of papilla duodeni major
timeFrame: 120 seconds
Secondary outcomes:
measure: Diagnostic yield in the upper GI-tract
timeFrame: up to 10 minutes
measure: time of investigation
timeFrame: up to 10 minutes
measure: complication rate
timeFrame: up to one week
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Stefan von Delius
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06291597: Vaping Adverse Lung and Heart Events Cohort
Official title: VapALERT: A Prospective, Exploratory and Adaptive Cohort Study to Identify Symptomatic and Asymptomatic Pulmonary and Cardiovascular Effects of Vaping
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaping
Electronic Cigarette Use
Keywords: Vaping
Vape
Electronic cigarette
Electronic and vaping acute lung injury
EVALI
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Ministere de la Sante et des Services Sociaux
First posted: 2024-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We seek to recruit 250 volunteers from the community with twice-a-year visits for a 5-year follow-up. We will recruit healthy volunteers as well as volunteers who have been previously diagnosed with chronic illness.

Brief summary: This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.

Detailed description: Daily vaping device users will be recruited in the Quebec City metropolitan area. Subjects will be asked to perform pulmonary function tests (spirometry, oscillometry, plethysmography, methacholine provocation) every 6 months for a 5-year follow up. Subjects will also answer a questionnaire assessing their vaping, tobacco and cannabis smoking habits, as well as their perceived respiratory symptoms. Blood draws and sputum inductions will be performed for cell counts and to measure inflammation markers.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Daily electronic cigarette user
* No respiratory infection in the 4 weeks before a visit

Exclusion Criteria:

* Women who are pregnant or breast-feeding.

Primary outcomes:
measure: Number of participants who vape daily with impaired lung volumes.
timeFrame: Every 6 months for 5 years
measure: Number of participants who vape daily with impaired lung diffusion capacity.
timeFrame: Every 6 months for 5 years
measure: Number of participants who vape daily with impaired spirometry.
timeFrame: Every 6 months for 5 years
measure: Number of participants who vape daily with airway hyperresponsiveness.
timeFrame: Every 6 months for 5 years
measure: Number of participants who vape daily with changes in blood cell count.
timeFrame: Every 6 months for 5 years
measure: Number of participants who vape daily with changes in sputum cell count.
timeFrame: Every 6 months for 5 years
measure: Vaping, tobacco and cannabis smoking habits of participants.
timeFrame: Every 3 months for 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: IUCPQ-UL
Study officials:
affiliation: Laval University
name: Mathieu C Morissette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04721197: Hens Hatching Hope
Official title: Program Evaluation: Eggs Hatching Hope. Providing Egg Vouchers to Women With Young Children in Rural Honduras.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Keywords: Stunting
Eggs
diarrhea
complementary foods
Lead sponsor: Georgia Southern University
Sponsor class: OTHER
Collaborators: name: Shoulder to Shoulder
First posted: 2021-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study is a prospective community-cluster non-randomized trial that will evaluate the effectiveness of a program that will provide 30-day egg vouchers to mothers of 6 to 24 month-old children living in rural areas of Intibucá, Honduras.


Eligibility criteria: Inclusion Criteria:

* Healthy children ages 6 to 24 months at the time the study begins
* No cerebral palsy, birth defect or condition that may affect their growth or development.
* Children living in the department of Intibucá, Honduras

Exclusion Criteria:

* Children from families that are considering leaving the region within the next 12 months
* Known egg allergy

Primary outcomes:
measure: Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months
timeFrame: 6 months
measure: Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 12 months
timeFrame: Change from baseline zHAZ at 12 months
Secondary outcomes:
measure: Changes in the prevalence of stunting from baseline at 6 months
timeFrame: 6 months
measure: Changes in the prevalence of stunting from baseline at 12 months
timeFrame: 12 months
measure: Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months
timeFrame: 6 months
measure: Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months
timeFrame: 12 months
measure: Assessment of rapid weight gain after 6 months of intervention
timeFrame: 6 months
measure: Assessment of rapid weight gain after 12 months of intervention
timeFrame: 12 months
measure: Changes in the prevalence of diarrhea from baseline at 12 months
timeFrame: 12 months
measure: Changes in the prevalence of Respiratory symptoms from baseline at 12 months
timeFrame: 12 months
measure: Changes in the prevalence of Respiratory infections from baseline at 12 months
timeFrame: baseline and 12 months
measure: Changes in the food insecurity scores from baseline at 6 months
timeFrame: 6 months
measure: Changes in the food insecurity scores from baseline at 12 months
timeFrame: 12 months
measure: Changes in the dietary diversity scores from baseline at 6 months
timeFrame: 6 months
measure: Changes in the dietary diversity scores from baseline at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Concepción
country: Honduras
facility: Clinica medica Roy and Melaney Sanders
state: Intibucá
Study officials:
affiliation: Indiana University, Bloomington
name: Ana Palacios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822497: Efficacy of Music Therapy Protocols for Burn Debridement
Official title: The Efficacy of Music Therapy Protocols for Decreasing Pain, Anxiety, and Muscle Tension Levels During Burn Debridement: A Prospective Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain Management
Keywords: music therapy
pain
anxiety
muscle tension
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Music School Settlement
name: Kulas Foundation
First posted: 2009-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns.

Detailed description: The study is a prospective, randomized crossover clinical trial conducted on a 14-bed inpatient comprehensive burn care center. The purpose of this study is to investigate the efficacy of Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) for pain and anxiety management for burn patients throughout the debridement process.

Eligibility criteria: Inclusion Criteria:

* Patient is admitted for at least three days (excluding day of admission)
* Patient is at least seven years old
* Patient is able to communicate, i.e. awake and alert
* Patient is oriented

Exclusion Criteria:

* Patient admitted for/less than three days
* Patient under seven years of age
* Patient not able to communicate, i.e. sedated and/or intubated
* Patient is not oriented, i.e. active psychosis, hallucinations, delusions, late-stage Alzheimer's or dementia diagnoses

Primary outcomes:
measure: Pain, Anxiety, Muscle Tension levels
timeFrame: 7 data points before, during, after debridement
Secondary outcomes:
measure: Narcotics & Anxiolytics (dosage)
timeFrame: Throughout debridement process
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: The Cleveland Music School Settlement
name: Xueli Tan, MM, MT-BC
role: STUDY_CHAIR
affiliation: MetroHealth Medical Center
name: Richard B. Fratianne, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prensner JD, Yowler CJ, Smith LF, Steele AL, Fratianne RB. Music therapy for assistance with pain and anxiety management in burn treatment. J Burn Care Rehabil. 2001 Jan-Feb;22(1):83-8; discussion 82-3. doi: 10.1097/00004630-200101000-00019.
citation: Fratianne RB, Prensner JD, Huston MJ, Super DM, Yowler CJ, Standley JM. The effect of music-based imagery and musical alternate engagement on the burn debridement process. J Burn Care Rehabil. 2001 Jan-Feb;22(1):47-53. doi: 10.1097/00004630-200101000-00010.
Clinical trial NCT00957697: Pain After Stroke, Part 2: Clinical Characteristics and Classification of Pain in Patients After Stroke
Official title: Pain After Stroke, Part 2: Clinical Characteristics and Classification of Pain in Patients After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Central Neuropathic Pain
Central Post-Stroke Pain
Stroke
Pain
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of stroke patients diagnosed in 2004-2005 in the County of Aarhus identified through the National Indicator Project Stroke Database of Denmark

Brief summary: The purpose of this study is to investigate the prevalence of characteristics of pain in a cohort of patients with prior stroke suspected of having central post stroke pain, identified through a postal questionnaire.

Detailed description: Medical history, pain history, pain drawing, DN4, sensory examination.

Eligibility criteria: Inclusion Criteria:

* Possible neuropathic pain following stroke

Exclusion Criteria:

* Severe dementia
* Severe language barriers
* Patients who cannot cooperate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Danish Pain Research Center
name: Henriette Klit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04433897: Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
Official title: Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nocturia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are biochochemically confirmed to be postmenopausal.

Brief summary: Aim of this study was to observe

The study was adjusted in two parts:

PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed.

PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.


Eligibility criteria: Inclusion Criteria:

* Women with postmenopausal symptoms (hot flushes, atrophy, ..)
* All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria

Exclusion Criteria:

* Intake of HRT on the moment of inclusion
* women with thyroid dysfunction
* women using antihypertensive agents
* women with a history of psychiatric or neurological disorders
* women with a history of alcohol or drug addiction.

Primary outcomes:
measure: Change in nocturnal Frequency
timeFrame: 6 months after initiating therapy
Secondary outcomes:
measure: Change in bother linked with nocturnal frequency
timeFrame: 6 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Department of Urology, Ghent University
state: Oost-Vlaanderen
Study officials:
References:
Clinical trial NCT06307197: HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia
Official title: HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Devices
Artificial Intelligence
Older People
Caregiver Burden
Keywords: dementia
caregiver
older people
technological devices
quality of life
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

Detailed description: The HAAL study is a feasibility study. The general objectives of the HAAL project is to be assessed the stress relief at work for formal and informal caregivers, the improvement in the perceived quality of life for informal caregivers and person with dementia, the reduction in case load for the formal caregivers and the increased cost-effectiveness of the HAAL solution in comparison to the available services. The experimentation will be carried out in 3 sites: Italy, The Netherlands and Taiwan. The study consists in a alpha phase (5 older adults with dementia, 5 formal caregivers and 5 formal caregivers) and in a beta phase (10 older adults with dementia, 10 formal caregivers and 10 formal caregivers).

Eligibility criteria: Inclusion Criteria:

* being the caregiver of a person with cognitive impairment or dementia;
* availability of time to participate;
* visit the assisted person at least two times at week or live with him/her.

Exclusion Criteria:

* Lack of written informed consent

Primary outcomes:
measure: Care load of caregivers
timeFrame: baseline, 1, 2, and 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA
name: Roberta Bevilacqua
role: STUDY_DIRECTOR
References:
Clinical trial NCT02967497: Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type
Official title: An Open Label Study of UanQiHuoLi Tang Plus Cisplatin-based Chemotherapy in Advanced Epidermal Growth Factor Receptor Wild Type Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer
Keywords: Chemotherapy
Herbal medicine
Lung cancer
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2016-11-18
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV.

Detailed description: This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV. Chinese herbal medicine was known to be beneficial adjuvant or alternative medicine for cancer treatment. However, the mechanism was unknown. This study wants to investigate the effect and mechanism of YQ1, which was proved to improve the antitumor immunity, to inhibit cancer progression, and to prolong overall survival of lung adenocarcinoma in a series of preclinical studies.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV), EGFR/ALK wild type.
* Subjects who plan to receive cisplatin-based chemotherapy.
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* ECOG performance status \>= 3
* WBC =\< 4,000 cells/μl, ANC =\< 1,500/mcL, Platelets =\< 100,000/mcL , Hemoglobin =\< 9 g/dL,
* Total bilirubin \>= 1.5 x upper limit of normal (ULN), AST \>= 1.5x ULN, ALT \>= 2.5 x ULN, Creatinine \>= 1.5x ULN
* Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure.
* Chronic or current Inflammatory Bowel Disease, post-surgery of intestine, Lynch syndrome, FAP, Peutz-Jegher.
* History of allergic reactions cisplatin
* Pregnant women are excluded; breastfeeding should be discontinued prior to study entry.
* Received any other clinical trail at the same time.
* Current dementia or other cognitive disorders.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: