louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05765786: Diagnosing Variable Primary Aldosteronism.
Official title: Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
High Blood Pressure
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 100
Sex: ALL
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: People with hypertension.

Brief summary: The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

Detailed description: The main questions it aims to answer are:

* Can we diagnose more people if we used 24 hour urine measurements?
* In those with high amounts of aldosterone in their urine, is there a variable pattern to their aldosterone production?

Participants will have a 24 hour urine measurement. They will also have multiple blood tests throughout the day to study the variability in aldosterone secretion.

Eligibility criteria: Inclusion Criteria:

* People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity \<0.5 nmol/h/L or renin mass \<5 ng/L), plasma sodium \> 140mmol/L or plasma potassium \< 4mmol/L.
* Patients who have been diagnosed with PA and had previous aldosterone samples \<277 pmol/L, a level which would normally not qualify for confirmatory testing.
* Patients with aldosterone results done at different times that indicate variability in production.
* Willing to consent and participate in the study.

Exclusion Criteria:

* Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
* People on end of life treatment.

Primary outcomes:
measure: Sensitivity and specificity of 24 hour urine tetrahydroaldosterone excretion.
timeFrame: 12 months
Secondary outcomes:
measure: Differences in timed day and night urine THA measurements.
timeFrame: 12 months
measure: Variation in aldosterone secretion from day series in those with positive 24h urine THA and those with negative 24h urine THA.
timeFrame: 12 months
measure: Complete or partial clinical cure rate of this cohort of patients that qualify for adrenalectomy
timeFrame: 12 months
measure: Complete biochemical cure of PA in this cohort of patients that qualify for adrenalectomy.
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
Study officials:
affiliation: Queen Mary University of London
name: William Drake, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04912986: Construction and Application of Early Lung Rehabilitation Training Programs
Official title: Construction and Application of Early Lung Rehabilitation Training Programs for Adult Patients After Double Lung Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Transplantation
Keywords: pulmonary transplantation
pulmonory rehabilitation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is intended to construct early lung rehabilitation training programs for adult patients after double lung transplantation, including safety assessment, exercise training, respiratory function training, psychological support and health education, with a view to helping double lung transplant patients achieve lung rehabilitation at an early date, improve patients' motor endurance and respiratory function, and improve the quality of near- and long-term survival.

Detailed description: The first stage constructs the lung rehabilitation program, and the second stage implements the non-contemporaneous study control trial.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* consent to early lung rehabilitation
* informed consent to this study.

Exclusion Criteria:

* Unstable condition, not allowed to receive pulmonary rehabilitation treatment
* A person with a mental disorder who cannot cooperate.

Primary outcomes:
measure: Mechanical ventilation time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiangshuyuan Liang, Master
role: STUDY_CHAIR
References:
Clinical trial NCT00808886: Study of Comparison Between Pentacam and locs3
Official title: Comparison Between Pentacam Scheimpflug System and locs3 in Grading of Cataract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: cataract
locs3
pentacam
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-12-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: catract patients who are coming for pre- surgical evaluation.

Brief summary: Hypothesis: There is no difference between pentacam scheimpflug system and locs3 in grading of cataract.

Major aims:

1. research the efficiency of pentacam scheimpflug system in lens density measurment.
2. To compare the pentacam with the locs3 in grading of cataract.


Eligibility criteria: Inclusion Criteria:

* cataract patient
* age\>18

Exclusion Criteria:

* pregnant women
* any disease of the eye except for cataract
* patients who are ineligible by law to take decisions by themselves.patients who have a custodian.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06160986: Horizons Chronic Graft-Versus-Host-Disease Study
Official title: Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Graft Vs Host Disease
Coping Skills
Quality of Life
Stem Cell Transplant Complications
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.


Eligibility criteria: Inclusion Criteria:

* underwent allogeneic hematopoietic stem cell transplant
* have moderate to severe chronic graft versus host disease
* currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
* able to participate in a group intervention in English or Spanish language

Exclusion Criteria:

* comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
* vulnerable patients, defined here as prisoners and pregnant women

Primary outcomes:
measure: Percentage of participant enrollment
timeFrame: Baseline (pre-intervention) to 10-week follow-up
measure: Percentage of participant attendance
timeFrame: Baseline (pre-intervention) to 10-week follow-up
measure: Percentage of participant retention
timeFrame: Baseline (pre-intervention) to 10-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lara Traeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05336786: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Official title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.

Detailed description: PRIMARY OBJECTIVES:

I. To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.

II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.

OUTLINE:

Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.

After completion of study, patients are followed up for 30 days.

Eligibility criteria: Inclusion Criteria:

* Subject must be scheduled for radical prostatectomy for treatment of prostate cancer
* Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
* Subject must be a male at least 18 years of age when informed consent is obtained

Exclusion Criteria:

* Participant in a clinical trial involving an investigational drug within the past 30 days
* Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity
* Previous treatment for prostate cancer, including hormone therapy
* Clinically unstable, severely ill, or moribund as per treating physician

Primary outcomes:
measure: Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
Study officials:
References:
Clinical trial NCT04780386: Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2
Official title: A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Detailed description: pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Primary outcomes:
measure: Pharmacokinetics of plasma: AUClast
timeFrame: 0hours - 72hours
measure: Pharmacokinetics of plasma: Cmax
timeFrame: 0hours - 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Nambusunhwan-ro
Study officials:
affiliation: H Plus Yangji Hospital
name: Jaewoo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180986: Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
Official title: Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child


Eligibility criteria: Inclusion Criteria:

* Children weighing 30 kg or less with a diagnosis of haematological malignancy or solid tumour, who were candidates for HSCT were eligible for inclusion in the study.
* Written informed consent was required from parents of eligible children.

Exclusion Criteria:

* Children were excluded if they had a anti-HLA and/or anti-HPA antibody, if they were prior included in this study or if the parents declined to participate.

Primary outcomes:
measure: The primary end point of the study was tocompare the number of platelet concentrates donors who were implicated in platelet transfusion supportive after HSCT.
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Valérie LAPIERRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00144586: Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 42
Sex: ALL
Minimum age (years): 20
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: This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.


Eligibility criteria: Inclusion criteria

* RA patients who participated in the previous studies
* Patients who completed the last observation in the previous studies
* Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

* Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
* Patients who were not enrolled by 3 months after the last observation day of the previous study

Primary outcomes:
measure: 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
timeFrame: throughout study
Secondary outcomes:
measure: Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
timeFrame: Week 0, then every 4 Week
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Yuji Kimura
role: STUDY_DIRECTOR
References:
Clinical trial NCT01672086: Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
Official title: Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System
Lead sponsor: StelKast, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-24
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with the Stelkast Surpass Acetabular System at the participating siteswill be included in the evaluation.

Brief summary: The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device.

Detailed description: This active surveillance study is intended to evaluate the survivorship and long-term safety and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the survivorship observed in a historical control group established by a meta-analysis. The evaluation will be conducted for a period of ten years. These evaluations will be recorded through onsite visits and/or mailings sent to physicians requesting deidentified patient-level data for subjects implanted with the Surpass system.

Eligibility criteria: Inclusion Criteria:

* Primary hip arthroplasty
* Skeletal maturity
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

Exclusion Criteria:

* The Stelkast Surpass Acetabular System is contraindicated in patients with the following conditions: Overt or latent infection in or around the hip joint, insufficient bone stock to allow appropriate insertion and fixation of the prosthesis, insufficient soft tissue integrity to provide adequate stability, muscle laxity or inadequate soft tissue for proper function and healing, mental or neuromuscular disorders that do not allow control of the affected joint, revision hip arthroplasty, inflammatory hip joint disease, and neuropathic hip joint disease.

Primary outcomes:
measure: Survivorship
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Gill Orthopedic Clinic
state: North Carolina
city: Canonsburg
country: United States
facility: Mutschler Orthopedic Institute
state: Pennsylvania
city: Glen Mills
country: United States
facility: Premier Orthopedics and SPM Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
Study officials:
affiliation: MCRA
name: Abigail Allen
role: STUDY_DIRECTOR
References:
Clinical trial NCT02704286: Risk and Risk Perception of Knee Osteoarthritis in the US
Official title: Raising Awareness of Knee Osteoarthritis (OA) and Willingness to Undertake Behavioral Changes to Reduce Risk of Knee OA: Online Recruitment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 380
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators have created an interactive knee osteoarthritis (OA) risk calculator that estimates a user's risk of developing symptomatic knee OA as well as the user's risk for undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk. Participants were randomized to either access general information about OA or use the risk calculator in addition to accessing general OA information. The investigators hypothesized that participants randomized to the risk calculator arm would have more accurate perception of their knee OA risk and would have increased willingness to change risky behavior compared to the general OA information group.


Eligibility criteria: Inclusion Criteria:

* Participants must be between the ages of 25 and 45
* Participants must live in the United States
* Participants must not be diagnosed with osteoarthritis

Exclusion Criteria:

* All participants who did not meet the inclusion criteria

Primary outcomes:
measure: Change in estimated lifetime knee OA risk
timeFrame: 1 day
measure: Change in estimated 10-year knee OA risk
timeFrame: 1 day
Secondary outcomes:
measure: Reaching an Action Stage on Diet Contemplation Ladder
timeFrame: 1 day
measure: Reaching an Action Stage on Exercise Contemplation Ladder
timeFrame: 1 day
measure: Reaching an Action Stage on Weight Control Contemplation Ladder
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Elena Losina, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Losina E, Klara K, Michl GL, Collins JE, Katz JN. Development and feasibility of a personalized, interactive risk calculator for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Oct 22;16:312. doi: 10.1186/s12891-015-0771-3.
citation: Michl GL, Katz JN, Losina E. Risk and risk perception of knee osteoarthritis in the US: a population-based study. Osteoarthritis Cartilage. 2016 Apr;24(4):593-6. doi: 10.1016/j.joca.2015.11.001. Epub 2015 Nov 7.
citation: Losina E, Michl GL, Smith KC, Katz JN. Randomized Controlled Trial of an Educational Intervention Using an Online Risk Calculator for Knee Osteoarthritis: Effect on Risk Perception. Arthritis Care Res (Hoboken). 2017 Aug;69(8):1164-1170. doi: 10.1002/acr.23136. Epub 2017 Jul 10.