louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05094037: Orthotic Treatment of Diabetic Foot Ulcers
Official title: Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-10-26
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.


Eligibility criteria: Inclusion Criteria:

* Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.

Exclusion Criteria:

* Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded
* All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)

  * scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded

Primary outcomes:
measure: Orthosis wear-time
timeFrame: At each clinic visit through study completion, an average of 8 months
measure: Foot ulcer size
timeFrame: At each clinic visit through study completion, an average of 8 months
measure: Foot ulcer healing status
timeFrame: At each clinic visit through study completion, an average of 8 months
measure: Number of foot ulcers
timeFrame: At each clinic visit through study completion, an average of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Muturi G. Muriuki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564637: A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Official title: Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Interstitial Lung Disease
Healthy Adults
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: United Therapeutics
First posted: 2022-10-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to find out more about the drug treprostinil via inhaler and the mechanisms of why patients with pulmonary arterial hypertension related to Interstitial Lung disease (PAH-ILD) have limitations during exercise. The investigator is studying treprostinil's effect on patients with PAH-ILD during exercise and its effect on their quality of life after using it for 3 months.


Eligibility criteria: Inclusion Criteria:

* Patients with Pulmonary Arterial Hypertension due to Interstitial Lung Disease (ILD-PAH) being considered for inhaled treprostinil
* Resting right heart catheterization with mean pulmonary artery pressure \>20 mmHg and PVR\> 3 Wood units
* Healthy volunteers will have no known lung disease, heart failure, muscular disease or pulmonary hypertension, no bleeding abnormalities, and have the ability to exercise.

Exclusion Criteria:

* Inability to exercise
* Females who are pregnant

Primary outcomes:
measure: Change in cardiac output reserve (Qc)
timeFrame: Baseline, approximately 35 minutes
Secondary outcomes:
measure: Change in ventilatory efficiency (VE/VCO2)
timeFrame: Baseline, approximately 35 minutes
measure: Change in New York Heart Association (NYHA) functional class
timeFrame: Baseline, 3-months
measure: Change in resting pulmonary vascular resistance
timeFrame: Baseline; after 30 minutes of rest
measure: Change in exercise pulmonary vascular resistance
timeFrame: Baseline; approximately 35 minutes
measure: Change in resting pulmonary artery pressure
timeFrame: Baseline; after 30 minutes of rest
measure: Change in exercise pulmonary artery pressure
timeFrame: Baseline; approximately 35 minutes
measure: Change in resting right atrial pressure
timeFrame: Baseline; after 30 minutes of rest
measure: Change in exercise right atrial pressure
timeFrame: Baseline; approximately 35 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogesh N Reddy, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689637: Drug Interaction Study Between AZD3480 and Warfarin
Official title: A Single-Centre, Double Blind, Randomized, Two-Way Cross-Over Study of Repeated Doses of AZD3480 and Single Dose of Warfarin to Evaluate the Pharmacokinetic Interaction of AZD3480 and Warfarin and the Effect of AZD3480 Pharmacodynamic in Healthy Male Subjects (Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: AZD3480
Warfarin
Drug interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent
* Clinically normal physical findings and laboratory values

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within three weeks before the first dose
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during days 5 and 6
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research SIte
Study officials:
affiliation: Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
name: Hans-Göran Hårdemark, MD
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions Manchester, UK
name: Cyril Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434337: Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
Official title: Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papillomavirus
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 600
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.

Detailed description: Primary Objectives

1. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").

Secondary Objectives

1. To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
2. To assess how different sample processing methods affect the performance of the Rice HPV test.
3. To assess how different test readout methods affect the performance of the Rice HPV test.

Exploratory Objectives

1. Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
2. Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
3. Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.

Eligibility criteria: Inclusion Criteria:

1. People with a cervix 21 years of age or older.
2. Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment OR are anticipated to undergo a LEEP, ECC, or biopsy.
3. Willing and able to provide informed consent.
4. Able to perform protocol-required activities. Able to speak and read English or Spanish.

Exclusion Criteria

1. Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy.
2. Participant or provider decision not to collect a sample for this study.
3. Participants that are pregnant.

Primary outcomes:
measure: Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen Schmeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00716937: Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus
Official title: Recurrence, Complications, Work-off Date, Healing Time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus Versus Excision With Healing by Secondary Intention (EHSI)Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pilonidal Sinus
Pilonidal Cyst
Keywords: pilonidal sinus
karydakis
laying open
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 321
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011


Eligibility criteria: Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

Primary outcomes:
measure: Recurrence
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Work off date, Healing Time
timeFrame: up to 1 Year after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of medical Sciences, Deputy of Research
Study officials:
affiliation: Tehran University of Medical Sciences
name: Amir Keshvari, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01938937: The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Official title: The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Valkee Oy
First posted: 2013-09-10
Enrollment: 60
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 purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.

Detailed description: Subjects (n=30) with anxiety symptoms will be recruited into the study. To be included into the study, subjects have to get at least seven points in BAI(Becks Anxiety Inventory). At the beginning of the study subject will be randomly assigned to 12 minutes of acute transcranial bright light or placebo exposure group. Anxiety symptoms will be measured using Spielberger State-Trait Anxiety Inventory (STAI, form Y1)self-rating questionnaire just before and 10 and 110 minutes after the experiment.

Eligibility criteria: Inclusion Criteria:

* Subject can read and understand the study protocol
* The written informed consent is obtained from subject
* Subject's BAI total score \>= 7

Exclusion Criteria:

* Subject has a lifetime psychotic disorder
* Subject abuses substance or has a dependence
* Subject has had suicidal idealization during the past month
* Subject use psychotropic medications
* Subject has unstable somatic disease
* Subject has used bright-light therapy for the current episode
* Subject is pregnant
* Subject is a relative of a member of research team
* Subject has used transcranial light treatment

Primary outcomes:
measure: Change in total score of STAI-Y1
timeFrame: just before exposure, 10 minutes and 110 minutes after the exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University
Study officials:
References:
Clinical trial NCT03144037: Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors
Official title: Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors - (AIs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hispanic population is targeted, yet study is open for all those who qualify.

Brief summary: This is an observational trial designed to assess prospectively the adherence rate to AIs among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant therapy after standard local and systemic therapy. We will study adherence by administrating the 8-item Morisky Medication Adherence Scale (MMAS - 8).

Detailed description: * Women with breast cancer seen at the Texas Tech Physicians Breast Care Center will be recruited during their routine follow-up visit with their medical oncologist.
* Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
* Patients must be on one of AI (steroidal or non-steroidal).
* Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
* Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish.

Eligibility criteria: Inclusion Criteria:

* Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
* Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
* Patient must be on one of AI (steroidal or non-steroidal).
* Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish

Exclusion Criteria:

* \< 18 years old

Primary outcomes:
measure: Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).
timeFrame: Every 6 months for up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University HSC El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Alexander Philipovskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05404737: Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography
Official title: Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Right Ventricle
Speckle Tracking
Strains
Cardiac Surgery
Keywords: Right ventricle
speckle tracking
Strains
cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE.

The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patient (\>18 years)
* Patient hospitalized at the Amiens University Hospital for scheduled cardiac surgery under cardiopulmonary bypass.
* Information of the patient and collection of his non-opposition

Exclusion Criteria:

* Patient with a contraindication to the realization of TEE (gastric or mediastinal pathology)
* Patient with poor echogenicity on TEE not allowing evaluation of 2D-STE parameters of the right ventricle
* Patient with a rapid supraventricular rhythm disorder (HR \> 100) at the time of TTE and/or TEE.

Primary outcomes:
measure: Variation of the RV-LSF (in %) between TTE and TEE
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT02434237: Robot-Aided Neurorehabilitation of the Upper Extremities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects and neurological patients after stoke or spinal cord injury

Brief summary: Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy is used in neurological rehabilitation for patients with paralyzed upper extremities due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury. The goal of the therapy is to recover motor function, improve movement coordination, learn new motion strategies ("trick movements"), and/or prevent secondary complications such as muscle atrophy, osteoporosis, and spasticity.


Eligibility criteria: Inclusion Criteria:

Patients with neurological disability of the upper limb with qualification for arm training, e.g. after stroke and spinal cord injury

Exclusion Criteria:

* limitations of the join mobility
* osteoporosis
* cardiovascular disease
* injury of the upper limb
* decubitus
* psychic diseases (like schizophrenia, dementia, depression)
* Body weight \> 120kg
* pacemaker.

Primary outcomes:
measure: The acceptanece of the arm rehabilitation robot therapy and the influence to the motivation through the visual feedback.
timeFrame: A measure lasts approx. 90 minutes. Every participant once.
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Swiss Federal Institute of Technology
Study officials:
References:
Clinical trial NCT01361737: Serum Markers in Preeclamptic Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
serological bio-bank
adiponectin
suPAR
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-05-27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Norwegian pregnant women

Brief summary: Could possible markers in serum obtained in the first trimester predict the human-pregnancy specific disorder pre-eclampsia?


Eligibility criteria: Inclusion Criteria:

* previous healthy

Exclusion Criteria:

* Previous inflammatory diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
References: