louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02052674: Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
Official title: Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Bacteriuria
Keywords: Precursor to CAUTI
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.

If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.

Detailed description: During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.

Eligibility criteria: Inclusion Criteria:

* Scheduled for a planned surgery
* Anticipated indwelling bladder catheter placement for greater than 24 hours
* Anticipated post-op admission to a surgical ICU

Exclusion Criteria:

* Unstable renal function as self-reported
* Anticipated bandaged postoperative suprapubic incisions
* Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
* Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature

Primary outcomes:
measure: Bacteriuria
timeFrame: 7 days
Secondary outcomes:
measure: Retained Urine
timeFrame: 7 days
measure: Presence of biofilms in catheter materials
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: William B. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04475874: Stretching Exercises on Symptoms of Primary Dysmenorrhea
Official title: Efficacy of Active Stretching Exercises on Symptoms of Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2020-07-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.

Detailed description: Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group B practiced non-supervised active stretching home program and the control group C . Visual Analog Scale (VAS) was used to measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .

Eligibility criteria: Inclusion Criteria:

* BMI of 20-29.9 kg/m2,
* regular menstrual cycle
* length 28-30 day
* cycle bleed from 3 to 7 days,

Exclusion Criteria:

* contraindication to stretching exercise
* taking any hormonal medications:
* smoker

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline at pain intensity 4 weeks after
Secondary outcomes:
measure: Verbal Multidimensional System(VMS)
timeFrame: Change from Baseline amenstruation characteristics 4 weeks after
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Zizi Mohammed Ibrahim Ali
state: Nnjkjk
Study officials:
References:
Clinical trial NCT01933074: Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency
Official title: Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Urinary Urgency
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Urogynecology clinic

Brief summary: The purpose of this study is to gain a better understanding of what causes urinary urgency in women by asking about different symptoms and measuring biomarker levels in their urine. Understanding the underlying causes of urinary urgency will allow us to develop treatment options to better take care of women with urinary urgency.

Detailed description: We propose to test the hypothesis that urinary urgency in women is caused by neurogenic inflammation that is manifested clinically as neuropathic pain and associated with the expression of neuroinflammatory biomarkers in the urine.

Eligibility criteria: Inclusion criteria: Age \> 18, urinary urgency (at least mild bother on a single item Urgency Scale), and negative urine dipstick on clean catch.

-

Exclusion Criteria:: Urinary incontinence (greater than mild on the Incontinence Severity Index), recent (\<6week) urinary tract infection, active or recent(\<3month) nephrolithiasis, prior diagnosis of congenital urinary tract abnormality, known neurological disorder (multiple sclerosis, Parkinson's, spina bifid, spinal cord injury), recent pregnancy \< 3 months, prior sacral nerve stimulation or Botox injection.

-

Primary outcomes:
measure: To determine the association between the severity of neuropathic pain and the severity of urinary symptoms in women with urinary urgency.
timeFrame: 1 year
Secondary outcomes:
measure: The association between neuropathic pain and the expression of potential neural biomarkers in the urine of women with urinary urgency.
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pelvic and Sexual Health Insitute
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Uduak Umoh-Andy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03836274: Tolerance and Acceptability Evaluation of MONACO
Official title: Tolerance and Acceptability Evaluation of MONACO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

Detailed description: To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Patients (\>18 years) who are able to communicate clearly.
* Patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement.
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement
* Informed assent/consent obtained.

Exclusion Criteria:

* Patients with cow's milk protein allergy requiring a milk free diet
* Patients with inherited metabolic conditions.
* Patients requiring enteral tube feeding or parenteral nutrition.
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list)
* Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
* Patients with dysphagia requiring stage 1, 2 or 3 thickened fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study

Primary outcomes:
measure: GI Tolerance
timeFrame: 9 Days
Secondary outcomes:
measure: Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
timeFrame: 9 days
Other outcomes:
Locations:
city: Haywards Heath
country: United Kingdom
facility: AYMES International
Study officials:
References:
Clinical trial NCT02528474: Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 19 years old
* Patients eligible for percutaneous coronary intervention
* Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent
* Reference vessel diameter of target lesion ≥2.5 mm

Exclusion Criteria:

* Cardiogenic shock
* Bifurcation lesion or totally occluded lesion
* Unprotected left main trunk lesion
* Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel
* Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
* Pregnant women or women with potential childbearing
* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
* Inability to understand or read the informed content

Primary outcomes:
measure: Neointimal thickness & area
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06922474: Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024 (BrEcho9Men)
Official title: Molecular Epidemiology of Enteroviruses Detected at the Virology Laboratory of Brest University Hospital During the Period 2018-2024: Retrospective Analysis of an Atypical Meningitis Epidemic in 2024
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Enterovirus Infections
Meningitis, Viral
Meningitis Enterovirus
Echovirus 9
Keywords: Echovirus 9
Enterovirus
Viral meningitis
Molecular epidemiology
Phylogenetic analysis
RT-PCR
Retrospective study
Surveillance
France
outbreak
Emerging variant
France epidemiology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 270
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a cerebrospinal fluid sample positive for enterovirus by RT-PCR performed at the virology laboratory of CHU de Brest between 2018 and 2024. This includes patients managed at CHU de Brest as well as at partner hospitals in Finistère (France) whose samples were processed centrally.

Brief summary: This study is being done to learn more about enterovirus infections detected in the cerebrospinal fluid of patients at CHU de Brest. Researchers will analyze medical records and laboratory data collected between 2018 and 2024. They will look at how these infections present in patients, and whether a specific virus type, called Echo-9, may be associated with different clinical features or represent an emerging variant.


Eligibility criteria: Inclusion Criteria:

* Cerebrospinal fluid (CSF) sample positive for enterovirus by RT-PCR between January 1, 2018 and December 31, 2024 , performed at the virology laboratory of CHU de Brest.
* No documented opposition to the use of medical data for research purposes.

Exclusion Criteria:

* Patients under legal protection (guardianship, curatorship, etc.)
* Refusal to participate in the study

Primary outcomes:
measure: Phylogenetic analysis of Echo-9 strains detected between 2018 and 2024
timeFrame: January 1, 2018 to December 31, 2024
Secondary outcomes:
measure: Temporal distribution of enterovirus infections documented at CHU de Brest
timeFrame: January 1, 2018 to December 31, 2024
measure: Clinical characteristics of enterovirus-positive CSF cases
timeFrame: January 1, 2018 to December 31, 2024
measure: Biological characteristics of enterovirus-positive CSF samples
timeFrame: January 1, 2018 to December 31, 2024
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT01487174: KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
Official title: A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Kadmon Corporation, LLC
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 8
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: This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.


Eligibility criteria: For Eligibility subjects must have:

* failed one or two previous courses of therapy.
* have no active brain metastasis. Treated non-active brain metastasis are acceptable.
* cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva \[erlotinib\] or Iressa \[gefitinib\]) in the past.
* has demonstrated progressive disease.

Primary outcomes:
measure: Overall survival
timeFrame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Secondary outcomes:
measure: Progression-free survival
timeFrame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
measure: Number and type of adverse events related to KD019
timeFrame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
measure: Objective response rate
timeFrame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
Study officials:
References:
Clinical trial NCT01909674: Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP
Official title: Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* previously diagnosed with OSA
* returning for PAP titrations at the Center for Sleep Medicine
* CPAP and titration naive
* Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr.

Exclusion Criteria:

* Patients with ≥ 50% central apneas

Primary outcomes:
measure: Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks
timeFrame: 3 weeks for each mask condition
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Center for Sleep Medicine
state: New York
Study officials:
References:
Clinical trial NCT04022174: Effects of Action Observation and Motor Imagery on Orofacial Sensorimotor Variables
Official title: Effects of Action Observation and Motor Imagery on Orofacial Sensorimotor Variables
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Motor Imagery
Action observation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the present study was to evaluate the effects of different dosages of action observation (AO) and motor imagery (MI) combined with an orofacial exercise program on pain pressure thresholds, lingual endurance and perceived exertion in asymptomatic subjects.


Eligibility criteria: Inclusion Criteria:

1. healthy individuals with no pain
2. aged between 18 and 65 years
3. subjects with correct masticatory function and labial and lingual mobility

Exclusion Criteria:

1. individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
2. underage individuals
3. individuals with orofacial pain or temporomandibular disorders at the time of the study
4. subjects' complaint of toothache or tenderness to percussion.

Primary outcomes:
measure: Pain pressure thresholds (PPTs)
timeFrame: Change from baseline and immediately post-intervention
measure: Lingual muscle endurance
timeFrame: Change from baseline and immediately post-intervention
measure: Perceived exertion
timeFrame: Change from baseline and immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT02506374: Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads
Official title: Project BEST-Sleep: A Pilot Study to Develop a Biobehavioral Self-Management Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Alzheimer's Disease
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community

Brief summary: This non-intervention qualitative study will use focus groups to assess the feasibility and acceptability of a proposed intervention for a future study. The focus group will discuss a potential biobehavioral family self-management intervention designed to improve sleep in persons with Alzheimer's disease (PAD) and their caregivers (CG).

Detailed description: Approximately 16 caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community. A series of two audiotaped focus groups will be conducted with these caregiver participants. The first focus group will explore perspectives on what constitutes a feasible and acceptable intervention to improve their sleep and associated symptoms. The second focus group will consist of follow up and confirmation of findings from the first focus group. The intervention will be developed and refined based upon focus group findings.

Eligibility criteria: Inclusion Criteria:

1. screen positive on the PROMIS sleep disturbance and associated symptoms measures
2. be a caregiver within a PAD/CG dyad
3. speak/understand English
4. agree to be audiotaped during focus group participation
5. be at least 18 years of age

Exclusion:

1. they negative on the PROMIS sleep disturbance and associated symptoms measures,
2. are not a caregiver within a PAD/CG dyad,
3. do not speak/understand English,
4. refuse to take part in audiotaping of the focus groups,
5. are not at least 18 years of age.

Primary outcomes:
measure: Qualitative Output from Focus Groups
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Jewish Senior Services
state: Connecticut
Study officials:
affiliation: Yale University
name: LuAnn Etcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: