louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01836601: Nighttime Communication Study
Official title: The Effect of a Family-Centered Nighttime Communication Bundle on Shared Mental-Model Building, Safety, and Patient Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: safety
patient experience
family-centered rounds
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Program for Patient Safety and Quality
First posted: 2013-04-22
Enrollment: 1334
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care.


Eligibility criteria: Inclusion Criteria:

* Parents of patients admitted to the general pediatrics inpatient units
* Overnight nurses working on the general pediatrics inpatient units
* Overnight residents working on the general pediatrics inpatient units

Exclusion Criteria:

* Non-English speaking parents

Primary outcomes:
measure: Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan
timeFrame: 18 months
Secondary outcomes:
measure: Parent-reported medical errors
timeFrame: 18 months
Other outcomes:
measure: Provider and parent experience of nighttime care
timeFrame: 18 months
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Khan A, Rogers JE, Forster CS, Furtak SL, Schuster MA, Landrigan CP. Communication and Shared Understanding Between Parents and Resident-Physicians at Night. Hosp Pediatr. 2016 Jun;6(6):319-29. doi: 10.1542/hpeds.2015-0224.
Clinical trial NCT00556101: Patient Acceptance of Whole Body Magnetic Resonance Angiography
Official title: Whole Body Magnetic Resonance Angiography: Questionnaire Examination of Patient Acceptance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Intermittent Claudication
MRI
Keywords: Magnetic resonance
whole body
angiography
questionnaire
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2007-11-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pheripheral arterial disease

Brief summary: Investigation of how the patients experience whole body MRA. After the WB-MRA the patients will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the patient felt during the examination.

We expect that the patients will report a high degree of satisfaction with the WB-MRA procedure, with little discomfort.

Detailed description: WB-MRA is performed in patients referred for conventional x-ray based angiography. The WB-MRA is performed first in all patients.

After both examinations are completed the patients will be asked to fill in a questionnaire containing questions about their experience of the 2 procedures.

We will then compare the results for the procedures.

Eligibility criteria: Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease

Primary outcomes:
measure: Patient acceptance of Whole body MRA
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev Copenhagen
country: Denmark
facility: Department of Radiology, Herlev University Hospital
state: Herlev
Study officials:
affiliation: University Hospital at Herlev Copenhagen Denmark
name: Henrik S Thomsen, Prof. MD.
role: STUDY_CHAIR
References:
Clinical trial NCT05488301: Effects of Chest Physiotherapy in Hyperventilation Syndrome
Official title: Effects of Chest Physiotherapy in Hyperventilation Syndrom : a Multicentric Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperventilation
Keywords: hyperventilation
quality of life
dyspnea
Nijmegen
anxiety
Lead sponsor: Centre Hospitalier des Pays de Morlaix
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hyperventilation syndrome adressed for chest physiotherapy

Brief summary: Hyperventilation syndrome induce dyspnea and altered quality of life. the aim of this study is to assess the impact of chest physiotherapy on hyperventilation syndrome' symptoms


Eligibility criteria: Inclusion Criteria:

* patients addressed for hyperventilation syndrome
* patient aged 18 years or over
* patient able to consent and having sign a consent form

Exclusion Criteria:

* respiratory disease (COPD, interstitial lung disease, bronchiectasis, cystic fibrosis, uncontrolled asthma)
* patient with an inability to complete questionaires
* refusal of participation
* patient under tutorship or curatorship

Primary outcomes:
measure: change of Nijmegen score
timeFrame: 5 weeks
Secondary outcomes:
measure: change of Nijmegen Score
timeFrame: 1 week
measure: change of Hospital Anxiety and Depression score (HAD)
timeFrame: 5 weeks
measure: change of Short Form-36 score (SF-36)
timeFrame: 5 weeks
measure: change of Dyspnea-12 score
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Morlaix
country: France
facility: BEAUMONT
Study officials:
References:
citation: Chenivesse C, Similowski T, Bautin N, Fournier C, Robin S, Wallaert B, Perez T. Severely impaired health-related quality of life in chronic hyperventilation patients: exploratory data. Respir Med. 2014 Mar;108(3):517-23. doi: 10.1016/j.rmed.2013.10.024. Epub 2013 Nov 7.
citation: Kiesel K, Burklow M, Garner MB, Hayden J, Hermann AJ, Kingshott E, McCullough G, Ricard R, Stubblefield G, Volz J, Waskiewicz D, Englert A. EXERCISE INTERVENTION FOR INDIVIDUALS WITH DYSFUNCTIONAL BREATHING: A MATCHED CONTROLLED TRIAL. Int J Sports Phys Ther. 2020 Feb;15(1):114-125.
Clinical trial NCT06404801: Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users
Official title: Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ankle Osteoarthritis
Knee
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: peoples selected based on having Polio or Proximal tibial fracture

Brief summary: I want to design Stance control orthotic knee joint for improvement of KAFO users which is not available in Pakistan imported stance control orthotic knee joints are very expensive patients can't afford. The aim of my study to develop low cost stance control knee joint and ensure its availablity for KAFO users.


Eligibility criteria: Inclusion Criteria:

* Polio Patient
* Proximal tibial fracture.

Exclusion Criteria:

* Patients without KAFO
* Cerebral Palsy Patients

Primary outcomes:
measure: Patient Satisfaction Through Questionnaire
timeFrame: 12 Months
measure: SF-36
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Peshawar North West General Hospital & Research Center
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT04463901: Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C
Official title: Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Pterygium
Keywords: recurrent pterygium
pterygium
limbal conjunctival autograft
conjunctival autograft
mitomycin c
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence

Detailed description: Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.

Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.

Eligibility criteria: Inclusion Criteria:

* Recurrent pterygium
* Willingness to participate in research project and to attend research time
* At least 6 months after last pterygium surgery

Exclusion Criteria:

* Pregnant,breast-feeding women or poor general health
* Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
* Patients with allergy to mitomycin C,tobramycin or local anesthetics

Primary outcomes:
measure: Recurrence of pterygium
timeFrame: One year
Secondary outcomes:
measure: Visual acuity
timeFrame: One year
measure: Healing time of corneal epithelium
timeFrame: Four weeks
measure: Healing time of conjunctival epithelium
timeFrame: Four weeks
measure: Postoperative complications
timeFrame: One year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Zhou Shiyou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004401: Study of Human Botulism Immunoglobulin in Infants With Botulism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Botulism
Botulism
Keywords: bacterial infection
clostridium infection
immunologic disorders and infectious disorders
infant botulism
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 120
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis).

II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.

Detailed description: PROTOCOL OUTLINE: This is an open label, multicenter study. Patients should begin therapy within 72 hours of hospital admission, but may receive human botulism immunoglobulin (BIG) in certain circumstances after 72 hours. Patients receive (BIG) IV. Patients are monitored for side effects, disease severity, complications, and length of hospital stay.

Patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinical diagnosis of infant botulism in previously healthy infant
* Bulbar palsies
* Constipated Lethargy
* Diminished head control
* Poor feeding
* Generalized weakness and hypotonia
* Weak cry
* Afebrile (unless secondary infection present)
* Subacute to acute onset
* Normal electrolytes
* Any patient eligible provided no treatment available for life-threatening condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: California Department of Health Services
state: California
Study officials:
affiliation: California Department of Health Services
name: Stephen S. Arnon
role: STUDY_CHAIR
References:
Clinical trial NCT04237701: Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System
Official title: Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Heart Failure NYHA Class IV
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry

Brief summary: The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.

Detailed description: Electronic Health Records based registries can be an important resource for precision medicine delivery by understanding the population burden of chronic diseases such as heart failure. These registries can allow for a deeper understanding of gaps in guideline recommended therapies among patients who are under the purview of large, integrated Therefore, we have created a live registry within the integrated Yale New Haven Health System-the Yale Heart Failure Registry-that includes all patients with a diagnosis of HF and has detailed information about demographics, comorbidities, laboratories, imaging, medications, and clinical outcomes (including hospital readmissions). The registry is updated daily and can be queried for clinically relevant questions aimed at quality improvement.

Eligibility criteria: Inclusion Criteria:

* Seen within the Yale New Haven Health System
* Diagnosis of heart failure

Exclusion Criteria:

* Age\<18

Primary outcomes:
measure: Number of participants hospitalized for heart failure
timeFrame: 10 years
measure: Doses of therapies that comprise guideline directed medical therapy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health System
state: Connecticut
Study officials:
affiliation: Yale University
name: Nihar Desai, MD MPH
role: STUDY_DIRECTOR
affiliation: Yale University
name: Tariq Ahmad, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greene SJ, Fonarow GC, DeVore AD, Sharma PP, Vaduganathan M, Albert NM, Duffy CI, Hill CL, McCague K, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Butler J. Titration of Medical Therapy for Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 May 21;73(19):2365-2383. doi: 10.1016/j.jacc.2019.02.015. Epub 2019 Mar 4.
citation: Ahmad T, Desai NR. Reimagining Evidence Generation for Heart Failure and the Role of Integrated Health Care Systems. Circ Cardiovasc Qual Outcomes. 2022 Apr;15(4):e008292. doi: 10.1161/CIRCOUTCOMES.121.008292. Epub 2022 Mar 11. No abstract available.
Clinical trial NCT04267601: Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM
Official title: A Non-interventional, Single Group, Open-label, Multicenter Observational Study to Evaluate the Efficacy and Safety of Anagliptin in Type 2 Diabetic Patients With Other DPP4is as Mono or Combination Therapy With Insufficient Glucose Control
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 2448
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients with other DPP4is as mono or combination therapy with insufficient glucose control

Brief summary: This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

Detailed description: Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.

Primary endpoint

- HbA1c change after 24 weeks treatment

Secondary endpoint

* Average rate of change in HbA1c after baseline
* Ratio of subjects with HbA1c\<7% after 24 weeks
* Ratio of subjects with HbA1c\<6.5% after 24 weeks
* Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease

Safety endpoint : Adverse Event

Eligibility criteria: Inclusion Criteria:

* 19 years of age at the time of consenting
* Understands and is willing to sign an informed consent form (ICF)
* HbA1c≥7.0%
* within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks

Exclusion Criteria:

* Prior exposure to Anagliptin

Primary outcomes:
measure: Change of HbA1C
timeFrame: after 24weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST. Mary's hopsital
Study officials:
References:
Clinical trial NCT02339701: Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer
Official title: A Randomized, Open Label, Phase II Study: Stereotactic Body Radiotherapy (SBRT) vs Conventional Intensity-modulated Radiotherapy (IMRT) for Low or Intermediate Risk Prostate Cancer in Asia Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 68
Sex: MALE
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: The primary goal of this phase II study is to compare the change of EPIC HRQOL scores (1-year minus baseline) between SBRT and IMRT.


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of prostate adenocarcinoma
* Low or intermediate risk prostate cancer patients (i.e. T1-T2c and PSA 20 and Gleason score \< 8) with the risk of pelvic node metastasis 15% as calculated by Roach's formula
* ECOG performance score 0-1
* Age ≥ 18
* History/physical examination within 2 weeks prior to registration
* Able to sign informed-consent

Exclusion Criteria:

* Patients with previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer.
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
* Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRHantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.DES), or surgical castration (orchiectomy)
* Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration
* Patients who have received prior chemotherapy.

Primary outcomes:
measure: health-related quality of life (HRQOL)
timeFrame: 1 year
Secondary outcomes:
measure: the rate of acute and late GI and GU toxicity
timeFrame: 5 years
measure: biochemical-failure free survival
timeFrame: 5 years
measure: disease-specific survival
timeFrame: 5 years
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
References:
citation: Poon DMC, Lam D, Wong KCW, Chu CM, Cheung M, Mo F, Suen J, Ng CF, Chan ATC. Prospective Randomized Phase II Study of Stereotactic Body Radiotherapy (SBRT) vs. Conventional Fractionated Radiotherapy (CFRT) for Chinese Patients with Early-Stage Localized Prostate Cancer. Curr Oncol. 2021 Dec 22;29(1):27-37. doi: 10.3390/curroncol29010003.