louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06412874: Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer
Official title: Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Screening Tool
Focus Group
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2024-05-14
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Bladder cancer survivors

Brief summary: The overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. Adult individuals diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. All data collected will be linked to a study ID number and HIPAA identifiers will not be linked to study data. Identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible to participate if they are diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer
* between 18 years and older (18-89 years)
* have initiated any systemic treatment for advanced urothelial carcinoma
* speak English speaking and are able to consent.

Exclusion Criteria:

* Have a diagnosis of another advanced cancer that has required systemic therapy
* Or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements.

Primary outcomes:
measure: The Bladder Cancer Need Assessment Survey (BCNAS)
timeFrame: 2023-2025
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Nihal Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877174: MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
Official title: MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internal Carotid Artery Stenosis
Keywords: Internal Carotid Stenosis
Reverse Flow
Carotid stenting
MICHI(TM) NPS+f
Lead sponsor: Silk Road Medical
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are booked for a routine stenting of the Internal Carotid Artery (bifurcation may be involved) using the MICHI(TM) NPS+f System, at vascular surgery departments or interventional radiology departments

Brief summary: This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE marked and is used in routine practice for the purpose of this study.


Eligibility criteria: Inclusion and exclusion criteria per CE marked Instructions For Use

Inclusion Criteria:

1. Adequate central venous access
2. Common carotid artery reference diameter of at least 6 mm
3. Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography

Exclusion Criteria:

1. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
2. Patients with unresolved bleeding disorders
3. Patients with severe disease of the ipsilateral common carotid artery

Primary outcomes:
measure: Percentage of patients with debris captured in the MICHI(TM) inline filter
timeFrame: During MICHI(TM) NPS+f procedure
Secondary outcomes:
measure: Volume of debris captured in the MICHI(TM) inline filter
timeFrame: During MICHI(TM) NPS+f procedure
measure: Histological analysis of debris captured in the MICHI(TM) inline filter
timeFrame: During MICHI(TM) NPS+f procedure
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital
city: Duesseldorf
country: Germany
facility: Augusta Krankenhaus
city: Palma
country: Spain
facility: University Hospital Son Espases
state: Mallorca
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Jaen
country: Spain
facility: Hospital Medico Quirurgic
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
Study officials:
References:
Clinical trial NCT04226274: A Study of the Safety of REN001 in Patients With McArdle Disease
Official title: A Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Patients With McArdle Disease (Glycogen Storage Disorder 5)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: McArdle Disease
Lead sponsor: OnKure, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 19
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 assess REN001 safety in subjects with McArdle Disease


Eligibility criteria: Inclusion Criteria:

* Subjects must give written, signed and dated informed consent
* Confirmed diagnosis of McArdle Disease
* Subjects must be able to remain on stable medication through the study and specifically must not commence or have changes to agents that affect metabolism such as medication for diabetes
* Follow a stable dietary regimen as documented by a 3-day dietary record obtained during the screening period.

Exclusion Criteria:

* Documented history of ongoing rhabdomyolysis
* Evidence of acute crisis from their underlying disease
* Currently following or planning to start a ketogenic diet
* Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer
* Have been hospitalized within the 3 months prior to screening for any major medical condition
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study
* Pregnant or nursing females

Primary outcomes:
measure: Adverse Events
timeFrame: up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto de Investigación Hospital 12 de Octubre
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery, Queens Square
Study officials:
affiliation: MRC Centre for Neuromuscular Diseases, London
name: Rosaline Quinlivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06003374: Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children
Official title: Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates, infants and children presented with suspected septic hip arthritis.

Brief summary: To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .

Detailed description: Septic arthritis is a severe life and function threatening condition with a 1-year mortality rate of up to 10% and residual functional impairments in 30% to 50% of cases . Pediatric Septic Hip Arthritis is an intra-articular infection in children that peaks in the first few years of life. The incidence of septic arthritis is low, with about 4-5 per 100000 child annually with about 50% of cases occur in children younger than 2 years of age with gender affection in male \> female (2:1 ratio). The hip joint involved in about 35% of all cases of septic arthritis. Imaging studies contribute crucially to the optimal management of septic arthritis, thereby diminishing the risk of permanent functional loss .At present; magnetic resonance imaging (MRI) is the most informative method. Thus, MRI assesses the severity of the synovitis and can detect a joint effusion, bone and/or cartilage destruction, an abscess, and/or bone edema. MRI had 75% specificity and nearly 100% sensitivity for diagnosing concomitant abscess formation, cellulitis, or myositis . Disadvantages of MRI are high cost and limited availability on an emergency basis in some settings , Ultrasonography of the bone and joints has been developing at a fast pace in recent years. Ultrasonography is currently used in the management of septic arthritis to confirm the presence of a joint effusion and to guide the joint aspiration or synovial biopsy, particularly when the effusion is small or the joint deep (e.g., hip). Ultrasonography has high sensitivity and specificity for joint effusions .The difficulty of applying hip MRI in pediatric age group patients especially neonates make challenge in the proper management of acute septic hip arthritis .the study aim to apply a new protocol in diagnosis of septic hip in children by doing extended hip ultrasound included psoas and quadriceps muscles.

Eligibility criteria: Inclusion Criteria:

* Neonates, infants and children presented with suspected septic hip arthritis.

Exclusion Criteria:

* DDH

Primary outcomes:
measure: To describe the ultrasound abnormalities seen in Patients with septic hip arthritis.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04479774: Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
Official title: Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: compelled body shift technique
stroke
tinetti performance oriented mobility assessment
Lead sponsor: Northwest Institute of Health Sciences, Pakistan
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants random allocation into control and experimental groups
Primary purpose: TREATMENT

Brief summary: Stroke is one of the major cause of lifelong disability if not treated on time, the investigator's technique knows as Compelled Body Weight Shift Technique (CBWS) was utilized and administered to chronic stroke population and results were figured out using gait parameters and Tinetti POMA scale.

Detailed description: Total 28 sample size out of which 27 were divided into control and experimental group. Inclusion criteria was Unilateral chronic stroke with asymmetrical stance, Patients with score of 3,4 and 5 will be included according to FAS (Functional Ambulation Scale), Ability to understand and follow instructions, Both male and female, Any type of stroke, and Age 40-60. Written and informed consent was obtained from participants of study. Six weeks of exercise training was combined with compelled body weight shift technique via shoe lift of 0.6 cm thickness for experimental group and for control group training was performed without shoe lift.

Eligibility criteria: Inclusion Criteria:

* Unilateral chronic stroke with asymmetrical stance
* Patients with score of 3,4 and 5 were included according to functional ambulation scale(59)
* Ability to understand and follow instruction
* Both male and female.
* Any type of stroke.
* Age 40-60.

Exclusion Criteria:

* • Serious or unstable medical, condition of patient.

  * History of other neurological diseases (i.e. Parkinson's disease, multiple sclerosis),
  * Contractures or any deformity.
  * Leg Length Discrepancy

Primary outcomes:
measure: Tinetti Performance Oriented Mobility Assessment
timeFrame: upto 6 weeks
Secondary outcomes:
measure: A 10meter walk test
timeFrame: upto 6 weeks
measure: Camry 160 Analog Weight Scale
timeFrame: upto 6 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Usman Farooq, Mspt
state: KP
Study officials:
References:
Clinical trial NCT00148174: Predictors and Intervention for Noncompliance
Official title: Predictors and Intervention for Noncompliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Keywords: Medication adherence
Patient compliance
Kidney transplant
Organ rejection
Allograft loss
Drug monitoring
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-07
Enrollment: 273
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.

Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Detailed description: Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant
* Discharged from hospital with functioning graft

Exclusion Criteria:

* Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
* Patients with active psychosis
* Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
* Patients taking the liquid form of azathioprine or mycophenolate mofetil
* Patients who are younger than 14 yrs. old
* Patients who do not speak English
* Receiving extra-renal organ except for pancreas,either simultaneously or previously
* Patients who live and will be followed outside of the United States, except Canada
* Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
* Patients who are not responsible for taking their own medications, e.g. living in a medical care facility

Primary outcomes:
measure: Graft loss
timeFrame: prospective
Secondary outcomes:
measure: Acute rejection
timeFrame: prospective
measure: Death
timeFrame: prospective
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Thomas E Nevins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04422574: COVID 19 Serology in Pulmonologists
Official title: COVID 19 Serology in Pulmonologists : Pneumo Sero Cov
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid 19
Keywords: Covid 19
serology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonologists of Languedoc Roussillon

Brief summary: Respiratory physicians are highly exposed workers to Covid-19 as they perform spirometry, endoscopy, and manage Covid-19 in first line for most of them. Moreover, none reported to have apply increased levels of protection for performing these acts in the most active period of viral circulation, until the lockdown. Whether they were most frequently immunized against SARS-CoV-2 at the end of the first wave than the general population is of utmost importance individually but also worldwide


Eligibility criteria: Inclusion Criteria:

* Pulmonologists of Languedoc Roussillon
* Actively working
* Registered

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: covid 19 serology
timeFrame: 1 day
measure: risk factors for positive serology testing
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Arnaud Bourdin, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03134274: Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.
Official title: Healthy.io Urine Dipstick Home Testing: a Pilot Study Among Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2017-04-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assess usability and preference of digital home urine testing with pregnant women. 300 pregnant women will be given a test kit and smartphone application during a clinic visit. Participants are instructed to conduct the test the next day. After conducting the urine test home participants fill out a survey assessing the satisfaction with digital home urine testing.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.

Detailed description: 300 pregnant women receive home testing kit and smartphone application (Dip HBDA) during regular prenatal visit. They are instructed to conduct a urine test (regular 10 parameter dipstick included in kit) at home using the Dip HBDA. After conducting the urine test, participants are to fill out a short questionnaire regarding ease of use, preference of testing and any problems encountered.

This study only assesses usability and questionnaire outcomes. The results of the test (indications on dipstick) are not subject to the study.

Eligibility criteria: Inclusion Criteria:

* English Speaking
* Own and are familiar with use of a smartphone

Exclusion Criteria:

* They do not have use of both hands.
* Are visually impaired (cannot read user manual)
* Have dementia or mental disorder.
* Are not able to fill urine receptacle.
* Are not willing to adhere to study procedures.
* Do not own or are not familiar with the use of a smartphone.
* Have no access to a wifi / or cellular data connection at their home.
* Have impaired vision that prevents them from reading instructions.

Primary outcomes:
measure: Ease of use and preference questionnaire
timeFrame: 2-3 months
Secondary outcomes:
measure: Usability of Dip HBDA
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Medical
name: Anne Burke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03636074: Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery
Official title: Effects of Hypothermia on Delayed Neurocognitive Recovery: an Observational Trial Among Patients Undergoing Cardiac-Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Emergence Delirium
Hypothermia
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective Observational Case-Control

Brief summary: Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.


Eligibility criteria: Inclusion Criteria:

* Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion Criteria:

* Neurological disease before surgery
* Sedation in Cardiac-Surgery Intensive Unit \> 6 hours
* Cerebral regional Oxygen saturation \<20% baseline during surgery

Primary outcomes:
measure: Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
timeFrame: Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery
measure: Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
timeFrame: Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery
measure: Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
timeFrame: Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery
measure: Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery
timeFrame: Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery
Secondary outcomes:
measure: Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery
timeFrame: One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Università degli Studi di Padova
state: PD
Study officials:
References: