louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06436001: Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease
Official title: Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease in All-comers and Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Diabetes Mellitus
Keywords: peripheral arterial disease
ankle brachial index
arterial duplex
Doppler waveform
Lead sponsor: Dakota Vascular
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024.

Brief summary: To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.

Detailed description: This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.

Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.

Exclusion Criteria:

* Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.

Primary outcomes:
measure: Sensitivity
timeFrame: data collected from March 2023 to March 2024
measure: Specificity
timeFrame: data collected from March 2023 to March 2024
measure: Accuracy
timeFrame: data collected from March 2023 to March 2024
measure: Cohen's Kappa coefficient
timeFrame: data collected from March 2023 to March 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Dakota Vascular
state: South Dakota
Study officials:
References:
Clinical trial NCT02931201: Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma
Official title: Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography /Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: Positron-Emission Tomography
Prognosis
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression during chemotherapy or survival in DLBCL.

Detailed description: In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold (1.6 fold of liver SUVmax) or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in DLBCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed DLBCL
* treated using an anthracycline-containing regimen with or without rituximab
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.

Primary outcomes:
measure: Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles
timeFrame: baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)
Secondary outcomes:
measure: 2 year progression-free survival
timeFrame: up to 2 years after initial diagnosis
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xuejuan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06827301: Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia Following Cerebrovascular Accident
Keywords: vagus nerve stimulation
dysphagia
stroke
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 30
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: The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition.

30 patients will be randomized into one of the two arms of the study:

* REAL: real t-VNS + speech therapy
* SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear.

Swallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).


Eligibility criteria: Inclusion Criteria:

* Acute ischemic or hemorrhagic stroke (within 7 days of onset)
* Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5

Exclusion criteria:

* Pre-existing stroke dysphagia
* Dementia or other medical conditions that may interfere with the study

Primary outcomes:
measure: Swallowing function
timeFrame: Baseline, Immediately after intervention
Secondary outcomes:
measure: Disability
timeFrame: Baseline, Immediately after intervention, 3 months after intervention
measure: Mortality
timeFrame: Baseline, Immediately after intervention, 3 months after intervention
measure: Morbidity
timeFrame: Baseline, Immediately after intervention, 3 months after intervention
measure: Swallowing function
timeFrame: Baseline, 3 months after intervention
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
state: RM
Study officials:
References:
Clinical trial NCT06468501: SEP and the Impact of Price on Food Selection in a Simulated Food Delivery App
Official title: Socioeconomic Position and the Effectiveness of Price Changes Based on Healthier and Less Healthy Food on Food Selection in a Simulated Out of Home Food Delivery App: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Healthy Eating
Eating Behavior
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 3464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a randomised controlled trial, with 4 (interventions) x 2 (high vs low SEP) between-subject conditions.
Primary purpose: PREVENTION

Brief summary: The goal of this randomised controlled trial is to compare taxation with subsidies to encourage healthier food choices in the out-of-home food sector. Participants will be asked to make hypothetical food choices in an online simulation study of a delivery app. Participants will be randomised into four different intervention groups:

1. Price reduction (10%) on healthier foods
2. Price increase (10%) to less healthy foods
3. A combination of price reduction to healthier foods and price increase to less healthy foods
4. Existing price structure (i.e. control group)

The investigators will further examine effectiveness of these fiscal policies on healthy eating by socioeconomic position to understand whether these policies are equitable.


Eligibility criteria: Inclusion Criteria:

* Currently reside in the United Kingdom
* Over the age of 18 years
* Order take-away food for delivery at least once a month
* Can complete the study on a laptop or desktop

Exclusion Criteria:

* Any major dietary restrictions (vegan, dairy/lactose-free, gluten-free) or allergies (dairy, eggs, nuts, soy, wheat) that would limit the number of dishes they could choose in the meal selection task

Primary outcomes:
measure: Healthier vs less healthy main meals ordered based on the Nutrient Profiling Model and total energy (kcal)
timeFrame: immediately after food choice
measure: Total energy (kcal) ordered
timeFrame: immediately after food choice
Secondary outcomes:
measure: Proportion of selecting healthier vs less healthy meal items of the total food order based on the Nutrient Profiling Model and total energy (kcal)
timeFrame: immediately after food choice
measure: Total fat, saturated fat, salt and sugar ordered
timeFrame: immediately after food choice
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Eric Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099801: Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Official title: Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Kidney, Transplantation, Rejection, Immunosuppression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing their first kidney transplant
* Male or female age 18 to 65 years

Exclusion Criteria:

* Patients in need of second kidney transplant or multi-organ transplants.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Saab G, Almony A, Blinder KJ, Schuessler R, Brennan DC. Reversible cystoid macular edema secondary to fingolimod in a renal transplant recipient. Arch Ophthalmol. 2008 Jan;126(1):140-1. doi: 10.1001/archophthalmol.2007.23. No abstract available.
Clinical trial NCT01982201: Antacid Interaction Study
Official title: A Phase 1, Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interaction Between Lesinurad and Calcium Carbonate and Aluminum/Magnesium Hydroxide-Containing Antacids in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the potential effects of calcium carbonate and aluminum/magnesium hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of lesinurad in healthy, adult male subjects.

Detailed description: In this study, lesinurad and antacid will be administered in the fed state, antacid doses will be attenuated to reflect the more commonly used doses, baseline PD assessments will be performed both in presence and absence of antacid treatment, and the sequence of treatments (lesinurad +/- antacid) will be randomized.

Eligibility criteria: Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Exclusion Criteria:

* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject donated blood or experienced significant blood loss (\>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: PK profile of lesinurad from plasma and urine
timeFrame: Day 2 and Day 7
measure: PD profile of Lesinurad from serum and urine
timeFrame: Day 2 and Day 7
Secondary outcomes:
measure: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Kalamazoo
country: United States
state: Michigan
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall
role: STUDY_DIRECTOR
References:
Clinical trial NCT03860701: Remote Ischemic Conditioning in Necrotizing Enterocolitis
Official title: Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterocolitis, Necrotizing
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-03-04
Enrollment: 15
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants \< 36 weeks with NEC (stages I-III as per Bell's modified classification).

Brief summary: Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.

Detailed description: An appropriately sized blood pressure cuff will be applied to an arm or leg and inflated to promote RIC. This study will be conducted in three phases to assess the feasibility and safety of RIC in relation to duration of ischemia time, number of cycles of RIC and whether it is feasible and safe to perform RIC on consecutive days.

Eligibility criteria: Inclusion Criteria:

* Patients with NEC (stages I-III Bell's Classification)
* Weight greater or equal to 750 g.
* Gestational age \< 36 weeks.
* Patients whose parents consent to participate in the study.

Exclusion Criteria:

* Patients with major congenital anomalies
* No antecedent of limb ischemia/limb thrombotic events.
* No antecedent diagnosis of occlusive arterial or venous thrombosis
* Hemodynamic instability

Primary outcomes:
measure: Limb perfusion after Remote Ischemic Conditioning
timeFrame: 1 days
Secondary outcomes:
measure: Cutaneous injury
timeFrame: 1 days
measure: Persistent pain
timeFrame: 1 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: Zozaya C, Ganji N, Li B, Janssen Lok M, Lee C, Koike Y, Gauda E, Offringa M, Eaton S, Shah PS, Pierro A. Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):69-76. doi: 10.1136/archdischild-2022-324174. Epub 2022 Aug 8.
Clinical trial NCT00760201: Qualitative Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels' Perceptions of End-of-Life Care
Official title: Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels� Perceptions of End-of-Life Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End of Life Care
Keywords: executive
administrator
perceptions
legal counsel
end of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-09-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital)

Brief summary: Interviewing hospital executives, physician administrators and hospital legal counsel who work in a hospital setting (academic, governmental, private or community hospital) about their perceptions concerning current and future end-of-life care provided in their facilities


Eligibility criteria: Inclusion Criteria:

Informant is a hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital) and is able to communicate perceptions verbally through use of English language. All participants will likely be nonveterans

Exclusion Criteria:

Primary outcomes:
measure: Perceptions of hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
state: Arkansas
Study officials:
affiliation: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
name: Kimberly K. Garner, MD JD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01024101: Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
Official title: Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
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 evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced head and neck cancer pretreated with surgery and/or radiotherapy and not suitable for further radical local treatment or patients with distant metastases who may have received no or one chemotherapy regimen

Exclusion Criteria:

* Patients with serious, uncontrolled medical illness

Primary outcomes:
measure: Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
measure: Safety: incidence and severity of adverse events, laboratory test abnormalities
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Secondary outcomes:
measure: Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: