louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06384066: Mobile Health Application to Improve Patient Satisfaction After Urethroplasty
Official title: Evaluation of a Mobile Health Application to Improve Patient Satisfaction and Outcomes After Urethroplasty: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urethral Stricture
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Create a custom urethroplasty mobile application that will guide patients through through the surgical process.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Have a Urethral stricture and are under going urethroplasty surgery

Exclusion Criteria:

* Patients that do not have mobile phone capabilities
* Patients who have physical or cognitive impairment when using a mobile phone or answering questionnaires
* Inability to provide consent to the study

Primary outcomes:
measure: Improve patient satisfaction, education and reported outcomes
timeFrame: 0 to 3 months
measure: Change in rate of patient phone calls and messages
timeFrame: 0 to 12 months
measure: Rate of emergency department visits
timeFrame: 0 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT01069666: Knowledge Base in the Treatment of Atopic Dermatitis Among Thai Pediatricians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Atopic Dermatitis
Keywords: atopic dermatitis
Thai pediatricians
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2010-02-17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 900 self-administered questionnaires were randomly mailed to pediatricians throughout Thailand

Brief summary: The purpose of this study is to determine knowledge base in diagnosis, investigation and treatment of pediatric atopic dermatitis among thai pediatricians.

Detailed description: Background: Currently, there is no existing information regarding prescribing practices for the management of childhood atopic dermatitis among pediatricians in Thailand.

Objective: In order to learn about basic knowledge, natural history, evaluation, diagnosis, treatment and prevention for childhood atopic dermatitis in Thailand

Methods: 900 self-administered questionnaires were randomly mailed to pediatricians throughout Thailand, asking about their preferences in the management of childhood atopic dermatitis. One hundred and eighty-five of these 900 questionnaires were returned (a response rate of 20.6%)

Eligibility criteria: Inclusion Criteria:

* All pediatricians who're working in thailand including sub-board pediatricians.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Facility: Faculty of Medicine Siriraj Hospital
Study officials:
References:
Clinical trial NCT03544866: The Impact of Pediatric Skin Disorders: The "Big" Study
Official title: The Impact of Pediatric Skin Disorders: The "Big" Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pediatric Skin Conditions
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Pediatric Dermatology Research Alliancce
name: Regeneron Pharmaceuticals
name: Immunex Corporation
First posted: 2018-06-04
Enrollment: 1666
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3,500 parent/child dyads across all sites (at least 50 parent/child dyads at each site).

Brief summary: This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

Detailed description: This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.

Eligibility criteria: Inclusion Criteria:

* Subjects must be aged 8-17 years of age
* Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor
* Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires
* Subject and Parent/Guardian must be able to complete the relevant questionnaires

Exclusion Criteria:

* Children under 8 years of age
* Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion
* Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing

Primary outcomes:
measure: Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool
timeFrame: Past 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Paller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00027066: Warfarin Versus Aspirin Recurrent Stroke Study
Official title: A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
aspirin
warfarin
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2001-11-21
Enrollment: 2206
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.

Detailed description: This study compared aspirin to warfarin to determine optimal therapy for the prevention of recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the final stages of the most common type of stroke due to blockage of the vessels that supply oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits circulating clotting proteins in the blood. Numerous previous studies have proven that use of aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin versus warfarin for stroke prevention has been the thinking among clinicians that warfarin may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it has greater side effects, increased risk of hemorrhage, and higher costs due to the need for blood tests to monitor the treatment effect for patients.

To make the aspirin and warfarin arms of the study as unbiased as possible, the investigators matched both groups of patients for primary stroke severity, age, gender, education, and race/ethnicity. The two groups were also matched for stroke risk factors, including hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity. The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically tailored to each individual patient.

This study found that aspirin works as well as warfarin in helping to prevent recurrent strokes in most patients.

Eligibility criteria: Inclusion:

* Acceptable candidates for warfarin therapy
* Had an ischemic stroke within the previous 30 days
* Had scores of 3 or more on the Glasgow Outcome Scale

Exclusion:

* Base-line INR above the normal range (more than 1.4)
* History of stroke due to a procedure or that was attributed to high-grade carotid stenosis for which surgery was planned
* History of stroke associated with an inferred cardioembolic source

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Health Sciences
state: New York
Study officials:
affiliation: Columbia University Health Sciences
name: J. P. Mohr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06465966: UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning
Official title: UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.


Eligibility criteria: Inclusion Criteria:

* Disease: Prostate cancer
* Treatment site:
* Prostate or prostate and seminal vesicle
* No regional lymph node is involved
* Patient's body weight: Patient's body weight is less than 350 lbs to consider the total weight limit that the ProteusONE treatment table and the robotic arm can operate
* Treatment volume size: maximum size less than 15 x 15 cm in a cross-section and a thickness less than 20 cm to consider 2D transducer matrix size
* Provision to sign the consent form and understand the non-invasiveness of iRAI
* Patient agreement on tolerance on placing a water bag to acquire iRAI during treatment
* Treatment modality: Proton radiation therapy with UFHPTI's ProteusONE gantry using PBS

Exclusion Criteria:

* A patient who would not be tolerable or will feel nervous about being touched on the skin with a water bag
* A patient with a significant medical implant or hardware in the treatment area

Primary outcomes:
measure: Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve
timeFrame: Approximately 24 months for trial accrual
Secondary outcomes:
measure: Reliability of range discrepancies between predicted values and iRAI during 3-day treatments at the proximal, center, and distal plane of a tumor to achieve
timeFrame: Approximately 24 months for trial accrual
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Univeristy of Florida Health Proton Therapy Institute
state: Florida
Study officials:
References:
Clinical trial NCT00745966: Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Official title: A 8-Week, Multicenter, Open-Label, Observational Study of Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Naturalistic
Observational
Keywords: Bipolar
atypical antipsychotics
quality of life
observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.


Eligibility criteria: Inclusion Criteria:

* The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent.
* Meet DSM-IV-TR criteria for bipolar disorder (bipolar I disorder, bipolar II disorder) at the time of baseline.

Exclusion Criteria:

* Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history.
* Known intolerance for or lack of response to atypical antipsychotics , as judged by the investigator.

Primary outcomes:
measure: The change from the baseline to week 8 in Short Form of the Quality of Life Enjoyment and satisfaction Questionnaire (Q-LES-Q) score
Secondary outcomes:
measure: The change from the baseline to week 8 in CGI-BP and GAF scale score.
Other outcomes:
Locations:
city: Kyunggi-do
country: Korea, Republic of
facility: Research Site
state: Choonchun-si
city: Dae-gu
country: Korea, Republic of
facility: RFesearch Site
state: Joong-gu
Study officials:
affiliation: Astrazeneca, Korea
name: Joon-Woo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT00210366: Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
Official title: Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of non-Hodgkin's lymphoma
* Disease exclusively localised into the CNS at first diagnosis and failure
* Progressive or recurrent disease
* Previous treatment with HDMTX containing CHT and/or RT
* Presence of at least one target lesion, bidimensionally measurable
* Age 18 - 75 years
* ECOG performance status \< 3 (Appendix 1).
* No known HIV disease or immunodeficiency
* HBsAg-negative and Ab anti-HCV-negative patients.
* Adequate bone marrow function (plt \> 100000 mm3, Hb \> 9 g/dl, ANC \> 2.000 mm3)
* Adequate renal function (serum creatinine \< 2 times UNL)
* Adequate hepatic function (SGOT/SGPT \< 3 times UNL, bilirubin and alkaline phosphatase \< 2 times UNL)
* Adequate cardiac function (VEF ≥ 50%)
* Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
* No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
* No concurrent treatment with other experimental drugs.
* Informed consent signed by the patient before registration

Primary outcomes:
measure: objective response to treatment
Secondary outcomes:
measure: duration of response
measure: overall survival
measure: acute side effects of idarubicin
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Servizio Radiochemioterapia - Ospedale San Raffaele
Study officials:
affiliation: San Raffaele Hospital - HSR Servizio di radiochemioterapia
name: Andres JM Ferreri, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03455166: Identification of New Prognostic Markers in Psoriatic Arthritis
Official title: Identification of New Prognostic Markers in Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Psoriatic Arthritis
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Identification of possible markers associated with the onset and / or progression of psoriatic arthritis through comparison in patients with psoriasis alone (Ps) and patients with psoriasis with joint involvement (PsA), plasma levels of a panel of cytokines referable to the Th17 pathway , together with serum levels of MMPs, TIMPs and markers of bone remodeling.

The primary objective of this study is to verify whether the arthropathy component has an effect on the metabolic activity of osteoblasts. This will be determined through the study of the differences in serum concentrations, between Ps and PsA subjects, of "CTx", the parameter best characterized in terms of analytical variability and intra- and inter-individual variability, in the field of bone metabolism.

The secondary objective is the verification of the differences in serum concentrations of the series of parameters specified above, in order to define a complete pattern of variations that can identify the molecular pathways involved in the definition of psoriatic arthropathy.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* For Ps group:

plaque psoriasis no previous treatment with biological drugs

- For PsA group: plaque psoriasis with arthropathy no previous treatment with biological drugs but in treatment as per clinical practice or, alternatively, last treatment with drug suspended by a number of days double compared to the half-life of the drug

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Neoplasia in progress or previous (\<5 years)
* Other acute or chronic inflammatory diseases
* Other rheumatological diseases
* Metabolic diseases of the primitive bone
* Recent bone fractures (\<6 months)
* Anxiety, psychosis, depressive disorders
* Inability to understand the information provided by the recruiter doctor
* For Ps group:

treatment with biological drugs

Primary outcomes:
measure: Different markers concentration
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01524666: Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
Official title: Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Neuropathy
Lead sponsor: JFK Medical Center
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic patients at JFK Med CTR

Brief summary: This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of Arginine) and monitored for two months. Improvement will be noted on their response to the Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by performing autonomic function testing at the beginning and end of the study.


Eligibility criteria: Inclusion Criteria:

* Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy

Exclusion Criteria:

* Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy

Primary outcomes:
measure: Neuropathic Pain Questionnaire
timeFrame: After 2 months
Secondary outcomes:
measure: QSART & ANSAR testing
timeFrame: After 2 months
Other outcomes:
Locations:
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
Study officials:
affiliation: JFK Medical Center
name: Michael Rosenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keynan O, Mirovsky Y, Dekel S, Gilad VH, Gilad GM. Safety and Efficacy of Dietary Agmatine Sulfate in Lumbar Disc-associated Radiculopathy. An Open-label, Dose-escalating Study Followed by a Randomized, Double-blind, Placebo-controlled Trial. Pain Med. 2010 Mar;11(3):356-68. doi: 10.1111/j.1526-4637.2010.00808.x.
citation: Rosenberg ML, Tohidi V, Sherwood K, Gayen S, Medel R, Gilad GM. Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study. Nutrients. 2020 Feb 23;12(2):576. doi: 10.3390/nu12020576.
Clinical trial NCT06337266: A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma
Official title: A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma After Radical Gastrectomy : A Multicenter Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: oxidative stress
inflammation
Gastric adenocarcinoma
nomogram
recurrence risk
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Fujian Medical University Union Hospital
First posted: 2024-03-29
Enrollment: 3622
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a multicenter, retrospective cohort investigation involving GC patients who underwent radical gastrectomy at the Fujian Medical University Union Hospital (FMUUH), the First Affiliated Hospital of Gannan Medical University (FAHGMU) and Quzhou Affiliated Hospital of Wenzhou Medical University (QAHWMU) between January 2009 and June 2020.

Brief summary: This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC).

Detailed description: From 2009 to 2020, this study analyzed GC patients underwent Radical Gastrectomy at three hospitals, dividing them into training, internal, and external validation cohorts. Twelve blood indicators were analyzed. The POSII Score was developed in the training cohort using the Least Absolute Shrinkage and Selection Operator (LASSO) technique. Additionally, two online nomogram calculators were created based on multivariate Cox regression within the training cohort and subsequently validated in internal and external validation cohorts.

Eligibility criteria: Inclusion Criteria:1) histopathologically diagnosed gastric adenocarcinoma, 2) undergoing radical gastrectomy for GC, 3) absence of tumor invasion into adjacent organs or distant metastasis, and 4) availability of complete laboratory data.

Exclusion Criteria: 1) non-adenocarcinoma gastric cancers, 2) gastric stump cancer, 3) receipt of neoadjuvant therapy, 4) a history of other malignancies, and 5) insufficient clinical data or follow-up information.

Primary outcomes:
measure: 5-year OS
timeFrame: 5 years or 60 months
measure: 5-year DFS
timeFrame: 5 years or 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: