louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04966442: GrandAides; a Workforce Innovation to Address Post Acute Care
Official title: GrandAides; a Workforce Innovation to Address Post Acute Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 98
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: Randomized controlled trial with two groups looking at post hospital care for patients who were admitted with congestive heart failure. The control group includes standard of care provided to the patients after discharge including a hospital employed community health worker. The intervention group receives a specially trained GrandAide following the GrandAide model for post acute care. Difference in ER visits and readmissions was measured.

Detailed description: GrandAides program is a credible messenger community health worker based program that assumes a community health worker from the community who has specialized education around a certain chronic condition will be able to support patients in the outpatient setting more effectively than current standard of care. In this study a GrandAide visited a patient discharged from the hospital in their home for 4 weeks providing education, checking vital signs, and assisting with communication with the cardiologist. The study measured the difference in hospital admissions and ER visits between the group that was assigned a GrandAid and the group that took part in standard care. The groups were assigned randomly. The difference was calculated using one and two tailed t-test results.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of heart failure Lives in 6 zipcode catchment area of Temple University Hospital Is followed by Temple Cardiology

Exclusion Criteria:

End Stage Renal Disease Housed in a Skilled Nursing Facility Substance Use Disorder Unable to give consent Doesn't speak English Under age 18

Primary outcomes:
measure: ER visits
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02783742: Provider-Patient Communication Coaching
Official title: Teaching Provider Communication Via Coaching to Reduce Burnout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provider Burnout
Communication
Keywords: provider-patient communication
coaching
feedback
burnout
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 859
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To examine the effect of a coaching intervention on provider burnout and communication

Detailed description: The investigator will recruit providers at Duke University and randomly assign them to receive (1) a communication coaching intervention or (2) a waitlist intervention. The investigator will survey all providers at Baseline and Follow Up. Providers randomized to the intervention arm will attend face-to-face meetings with study coaches, and have some of their encounters with patients shadowed by a coach or audio recorded. Providers will obtain verbal consent from patients to participate in the study (i.e. have their encounter shadowed or audio recorded). Providers will then be provided feedback by coaches on their communication during these encounters. Providers randomized to the waitlist intervention arm will be offered the option of receiving this intervention after they complete the follow up survey.

Eligibility criteria: Inclusion Criteria:

* Providers and patients at Duke University Medical Center

Exclusion Criteria:

* Younger than 18
* non-English speaking

Primary outcomes:
measure: Change in provider burnout, as measured by questionnaire
timeFrame: baseline and follow up, approximately 2 months
Secondary outcomes:
measure: change in comfort addressing emotion, as measured by questionnaire
timeFrame: baseline and follow up, approximately 2 months
measure: change in self-rated efficiency, as measured by questionnaire
timeFrame: baseline and follow up, approximately 2 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: Pollak KI, Gao X, Beliveau J, Griffith B, Kennedy D, Casarett D. Pilot Study to Improve Goals of Care Conversations Among Hospitalists. J Pain Symptom Manage. 2019 Nov;58(5):864-870. doi: 10.1016/j.jpainsymman.2019.06.007. Epub 2019 Aug 16.
Clinical trial NCT01582542: Desmopressin for Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Bladder Reconstruction
Official title: Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nocturnal Enuresis
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 50
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 purpose of this study is to prospectively assess whether Desmopressin, given for a period of month to patients after radical cystectomy with orthotopic bladder reconstruction, improves and lowers the rate of nocturnal enuresis.

Detailed description: We will prospectively assess the utilization of Desmopressin in improving nocturnal enuresis in patients after radical cystectomy with orthotopic bladder reconstruction.

Patients after radical cystectomy with neobladder reconstruction will be given Desmopressin 0.1 mg once a day for a duration of one month.

Before beginning treatment patients will be given the NNES-Q questionnaire to assess severity of nocturnal enuresis.

At the end of treatment, the same questionnaire will be given to all patients to assess if nocturnal enuresis improved.

Sodium levels will be tested before treatment, 2 weeks after beginning treatment and at the end of treatment.

Eligibility criteria: Inclusion Criteria:

* Age above 18
* Able to give informed consent
* Patients afte radical cystectomy with orthotopic bladder reconstruction with night time incontinence

Exclusion Criteria:

* Patients with after radical cystectomy with orthotopic bladder reconstruction with daytime urinary incontinence
* Patients already treated with Desmopressin due to other reasons.
* Patients with an allergy or insensitivity to Desmopressin.
* Patients with known hyponatremia
* Patients with severe chronic renal failure and creatinine clearance of below 50 cc/sec.
* Patients with severe congestive heart failure
* Patients with active urinary tract infection
* Patients taking drug therapy which can interact with Desmopressin and affect it's action.Examples include Diuretics, Tricyclic antidepressants, Carbamezapine and Chlorpropamide AND Indomethacin.
* Patients with an indwelling urinary catheter.

Primary outcomes:
measure: Rate of improvement in Nocturnal incontinence
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tiqva
country: Israel
facility: Institute of Urology, Rabin Medical Cetner
state: Petach Tiqva
Study officials:
affiliation: Rabin Medical Center
name: Ofer Yossepowitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706042: Effects of Legumes on Glucose Regulation
Official title: Over-night Metabolic Effects of Legumes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Prevention
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Anti-Diabetic Food Centre
First posted: 2012-10-15
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Dietary prevention strategies are increasingly recognized as essential to combat the current epidemic of obesity and related metabolic disorders. The purpose of the present study was to evaluate the potential effects of legumes in relation to cardiometabolic risk markers and appetite regulating hormones.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects between 20-35 years
* With normal BMI and
* No known metabolic- or gastro intestinal disease

Exclusion Criteria:

* BMI \> 25,
* Known metabolic disorder or
* Gastrointestinal problems or disease

Primary outcomes:
measure: blood glucose
timeFrame: 11 hours
Secondary outcomes:
measure: satiety
timeFrame: 11 hours
Other outcomes:
measure: inflammatory markers
timeFrame: 11 hours
Locations:
city: Lund
country: Sweden
facility: Applied Nutrition and Food Chemistry, Lund University
Study officials:
References:
citation: Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
citation: Papanikolaou Y, Fulgoni VL 3rd. Bean consumption is associated with greater nutrient intake, reduced systolic blood pressure, lower body weight, and a smaller waist circumference in adults: results from the National Health and Nutrition Examination Survey 1999-2002. J Am Coll Nutr. 2008 Oct;27(5):569-76. doi: 10.1080/07315724.2008.10719740.
citation: Nilsson A, Johansson E, Ekstrom L, Bjorck I. Effects of a brown beans evening meal on metabolic risk markers and appetite regulating hormones at a subsequent standardized breakfast: a randomized cross-over study. PLoS One. 2013;8(4):e59985. doi: 10.1371/journal.pone.0059985. Epub 2013 Apr 5.
Clinical trial NCT00152542: Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
Official title: Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prematurity, Respiratory Distress Syndrome,Hypoxemia
Keywords: Inhaled nitric oxide,
Lung recruitment,
Ventilatory approach,
Neurodevelopmental outcomes,
School age children
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2005-09-09
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.

Detailed description: Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).

Eligibility criteria: Inclusion Criteria:

* Children who participated in NOVA study and are of school age

Exclusion Criteria:

* Children who participated in NOVA study but deceased post discharge

Primary outcomes:
measure: Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life
timeFrame: 4-7 years of age (between 2005-2006)
Secondary outcomes:
measure: Examine health status at early school-age
timeFrame: 4-7 years of age (between 2005-2006)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago, Comer Children's Hospital,
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael D Schreiber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patrianakos-Hoobler AI, Marks JD, Msall ME, Huo D, Schreiber MD. Safety and efficacy of inhaled nitric oxide treatment for premature infants with respiratory distress syndrome: follow-up evaluation at early school age. Acta Paediatr. 2011 Apr;100(4):524-8. doi: 10.1111/j.1651-2227.2010.02077.x. Epub 2010 Dec 1.
Clinical trial NCT01427842: Dose Enhancement of Vancomycin IN Everyday Patients
Official title: A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vancomycin Therapy
Keywords: Trough concentration
Vancomycin
Pharmacokinetics
Lead sponsor: The Canberra Hospital
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current Australian guidelines for vancomycin commonly underdoses individuals particularly in the first 48 hours.

The aim of the trial is to compare two dosing regimens; the current Australian guidelines versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of developing a new vancomycin dosing strategy that will enable patients to have more individualised and therapeutically efficacious treatment.

The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen increases the likelihood of achieving therapeutic trough levels of vancomycin within the first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin according to the current Antibiotic guidelines.

Detailed description: DEVINE will be a randomised controlled trial of a new vancomycin dosing regimen against a control.

The control group regimen will receive the doses recommended by Therapeutic Guidelines - Antibiotics 2010. The intervention group will receive a dosing regimen that has been devised by modelling the antibiotic properties within the body over a large range of renal function and weight that will be more specific for the individual patient. They will receive this regimen for approximately 36-60 hours at which point they will have a vancomycin level blood test (a routine practice as part of their normal care). After this time the treating team will determine further dosing requirements.

All patients will be randomised at commencement of vancomycin with consent being obtained for the trial prior to the first dose of vancomycin

Eligibility criteria: Inclusion Criteria:

* All patients in general wards requiring routine treatment with vancomycin

Exclusion Criteria:

* GFR \< 30mL/min(as measured by Cockcroft Gault equation)
* Age \< 16 yrs
* Weight \> 200kg
* Patients dosing with Vancomycin other than BD according to national guidelines (ie continuous infusions, q6h etc)
* Vancomycin infused at a rate other than 500mL/min

Primary outcomes:
measure: Trough vancomycin concentration
timeFrame: At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin
Secondary outcomes:
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
Study officials:
affiliation: The Canberra Hospital
name: Kathryn Daveson, Bsc, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06277206: A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma
Official title: A Study Using 18F-FAPI PET to Evaluate Pathologic Response to Systemic Treatment in Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 18F-FAPI
Pancreas Adenocarcinoma
Systemic Treatment
Pathologic Response
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients with resectable, borderline or locally advanced disease who plan to undergo systemic treatment, including chemotherpy or chemoimmunotherapy

Brief summary: To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC


Eligibility criteria: Inclusion Criteria:

* suspected to have pancreatic cancer by radiological imaging
* planned systemic treatment
* possibility of conversion surgery
* willingness to participate the study

Exclusion Criteria:

* without pathologically confirmed pancreatic cancer
* poor performance status or organ functions that cannot meet the systemic treatment requirements
* metastatic disease
* pregnant patients

Primary outcomes:
measure: Change of Maximum standardized uptake value
timeFrame: Baseline and preoperation
measure: Change of Mean standardized uptake value
timeFrame: Baseline and preoperation
Secondary outcomes:
measure: Maximum standardized uptake value
timeFrame: Baseline
measure: Mean standardized uptake value
timeFrame: Baseline
measure: Metabolic Tumor Volume
timeFrame: Baseline
measure: Total Lesion FAP expression
timeFrame: Baseline
measure: Change of Metabolic Tumor Volume
timeFrame: Baseline and preoperation
measure: Change of Total Lesion FAP expression
timeFrame: Baseline and preoperation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital, Medical College of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06295406: Reading Ability in Childhood Obesity
Official title: Reading Ability in Childhood Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Childhood
Obesity, Adolescent
Keywords: Reading abilities
Cognitive functioning
Neuropsychological assessment
Motor abilities
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 64
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).

Brief summary: There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.

In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.


Eligibility criteria: Inclusion criteria

• diagnosis of overweight or obesity

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Primary outcomes:
measure: Raw score at the neuropsychological assessment
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
References:
Clinical trial NCT05588206: Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
Official title: Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Brain Metastases
Keywords: lung cancer
Brain Metastases
Hypofractionated Stereotactic Radiotherapy
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Hangzhou Cancer Hospital
First posted: 2022-10-20
Enrollment: 21
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 objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

Detailed description: The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

Eligibility criteria: Inclusion Criteria:

* Histology confirmed that it was non-small cell lung cancer
* 1 to 10 brain metastases detected by magnetic resonance imaging (MRI)
* A life expectancy of \>3 months according to the DS GPA.
* KPS ≥70
* Control of the primary lesions (thorax) at the time of SBRT
* 2cm\<Tumor size ≤ 4 cm
* Age of 18-75 years old
* Patients must be able to undergo contrast enhanced MRI for planning
* Adequate bone marrow and organ function

Exclusion Criteria:

* other malignant tumors
* Prior surgery to brain metastasis
* Prior brain radiotherapy
* Non-small cell lung cancer with more than 10 brain metastases detected by MRI
* Contraindication to receiving radiotherapy.

Primary outcomes:
measure: MTD
timeFrame: 1 years
Secondary outcomes:
measure: ARE
timeFrame: 2 years
measure: iPFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Kaicheng Pan
Study officials:
References: