louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04871945: Protective Antibody Level After COVID-19 Vaccination Among Patients Under Hemodialysis
Official title: Evaluation of Protective Antibody Production After COVID-19 Vaccination Among Patients Under Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vaccine Reaction
Hemolysis
End-stage Renal Disease
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Seegene Medical Foundation
First posted: 2021-05-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients group : Patients under hemodialysis Control group : Healthy population

Brief summary: The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.


Eligibility criteria: Inclusion Criteria:

* The person who is vaccinated with ChAdOx1 (COVID-19 vaccine)
* The person who agrees with the protocol of the study

Exclusion Criteria:

* Age \< 18 years
* Pregnants
* Experience of COVID-19 infection

Primary outcomes:
measure: The change in the level of neutralizing antibody against SARS-CoV-2
timeFrame: Day 0, 14, 28, 56, 91, 120
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References:
citation: Park JS, Minn D, Hong S, Jeong S, Kim S, Lee CH, Kim B. Immunogenicity of COVID-19 Vaccination in Patients With End-Stage Renal Disease Undergoing Maintenance Hemodialysis: The Efficacy of a Mix-and-Match Strategy. J Korean Med Sci. 2022 Jun 13;37(23):e180. doi: 10.3346/jkms.2022.37.e180.
Clinical trial NCT06988345: Juxtarenal Aortic Aneurysm
Official title: Outcome Juxtarenal Aortic Aneurysm After Open Repair
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Juxtarenal Aneurysms
Open Repair
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: University Hospital Augsburg
name: University Hospital, Aachen
name: Goethe University
name: University Hospital Heidelberg
name: University Hospital Regensburg
name: University of Hamburg-Eppendorf
First posted: 2025-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a juxtarenal aneurysm who fulfill the inclusion criteria or do not fulfill the exclusion criteria may be included in this study

Brief summary: All patients with a juxtarenal abdominal aortic aneurysm who underwent open aneurysm therapy between January 2010 and July 2020 were included retrospectively.


Eligibility criteria: Inclusion Criteria:

* Patients with a juxtarenal aneurysm (defined as infrarenal neck \<10mm and clamping above at least one renal artery \[31592091\])
* Open therapy with infrarenal (Anschluss)
* \>18 years

Exclusion Criteria:

* Patients with an anastomosis above the renal arteries (e.g. including bypass to a renal artery)
* Patients with supravisceral clamping
* Patients with reconstruction of the aorta in the suprarenal area
* Patients with connective tissue diseases (e.g. Marfan syndrome or Ehler Danlos syndrome)
* Post-dissection aneurysms
* Infected aneurysms
* Conversions after endovascular therapy
* Inflammatory aneurysms

Primary outcomes:
measure: Mortality
timeFrame: 30 days after intervention
measure: Acute renal failure
timeFrame: 30 days after intervention
Secondary outcomes:
measure: Dialysis
timeFrame: during Follow up period, checked every year
measure: Reinterventions
timeFrame: during Follow up period, checked every year
measure: Mortality
timeFrame: during Follow up period (up to 13 years)
measure: Aneurysm-related Mortality
timeFrame: during Follow up period (up to 13 years)
measure: Post-operative complication rates
timeFrame: During Follow-up period (up to 13 years)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05336045: Satisfaction and Recovery After Trigger Finger Release
Official title: Satisfaction and Recovery After Trigger Finger Release- a Prospective Cohort Study With Weekly PROMs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigger Finger Disorder
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled for trigger finger release

Brief summary: Trigger finger release is one of the most common procedures in hand surgery. However, little is known about the patient perceived outcome directly after surgery and the timespan to recovery of normal hand function.This study focuses on patient reported outcome scores within the first six weeks after surgery.

Detailed description: Patients scheduled for release of trigger finger are assessed regarding the following outcome measures:

1. VAS score for pain
2. VAS score for finger movement
3. VAS score for fréquence of triggering
4. HAKIR questionnaire (validated instrument for hand function in the Swedish national hand registry)
5. Quick-DASH questionnaire.

After surgery, the patients records the following outcomes:

Each day: 1,2,3 and records of pain medication details Each week: 4,5

for 6 weeks

Eligibility criteria: Inclusion Criteria:

1. Trigger phenomenon and/or
2. Tenderness volarly to MCP joint of affected finger/thumb
3. Patient scheduled for trigger finger release
4. Signed informed consent

Exclusion Criteria:

1. Concomitant hand injuries/ conditions
2. Multiple fingers/thumbs to be treated
3. Unable to read/understand instructions in Swedish

Primary outcomes:
measure: Self-assessed hand function
timeFrame: every week for 6 weeks
Secondary outcomes:
measure: Pain (assessed by patient)
timeFrame: 6 weeks
measure: Movement of finger (self-assessed by patient)
timeFrame: 6 weeks
measure: Frequency of trigger phenomenon (self-assessed by patient)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Alingsås lasarett
Study officials:
References:
Clinical trial NCT02962245: Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
Official title: Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Berberine
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research aim to find out whether berberine can reduce the annual recurrence rate of ulcerative colitis in remission.

A total of 238 patients with ulcerative colitis in remission will be randomly divided into two groups.One will receive regular treatment,and the other group will receive extra oral berberine 300 mg three times daily for a year.

The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points or more ).

The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease activity index scores at the baseline and final assessments.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis with ulcerative colitis(according to the second European evidence-based consensus on the diagnosis and management of ulcerative colitis);
2. Disease remission of ulcerative colitis(a total Mayo Clinic score of 2 points or less and an endoscopic score of 1 point or less);
3. Diagnosis of moderate or severe ulcerative colitis within 3 months(a total Mayo Clinic score of 6-12 points)

Exclusion Criteria:

1. Prior bowel resection surgery;
2. Women who are planning or actual pregnancy or lactation during study period;
3. Patients allergic to berberine;
4. History of disease that would interfere with their participation in the trial, including malignant diseases, bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, and mental or emotional disorder;
5. Take the following treatment:

   * Unstable dose of 5-ASA drugs (oral and/or rectal route) within 14 days prior to screening;
   * Unstable dose of any immunomodulating/suppressive agents and any Anti-TNF therapy within 3 months prior to screening;
   * Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form) within 7 days prior to screening.

Primary outcomes:
measure: Annual Recurrence Rate
timeFrame: a year
Secondary outcomes:
measure: Disease exacerbation rate measured by Mayo Clinic disease activity index scores
timeFrame: a year
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
timeFrame: a year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00234845: Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
Official title: A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis


Eligibility criteria: Inclusion Criteria:

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
* Subject must be in paid employment
* Subject has self-reported work impairment since onset of symptoms

Exclusion Criteria:

* A subject has chronic arthritis diagnosed before age 16 years.
* Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
* Subject has preceding treatment with any biological TNF antagonist
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Primary outcomes:
measure: Job loss measurement
Secondary outcomes:
measure: Job productivity measurements
measure: Patient reported outcomes
measure: DAS28
measure: Safety parameters
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Global Medical Information - Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Beverly Paperiello
role: STUDY_DIRECTOR
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Clinical trial NCT06481345: Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele (CARPEDIEM)
Official title: Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myeloproliferative Disorders
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by hematologists of the French Intergroup of MPN

Brief summary: Retrospective study assessing the impact of IDH1/2, SRSF2 or SF3B1 mutations on event free survival of MPN patients

Detailed description: Patients with a diagnosis of MPN and a mutation of IDH1/2, SRSF2 or SF3B1 will be included. Clinical and biological characterisation at diagnosis, as well as evlution will be recorded. Event free survival will be assessed in each group (event = thrombosis, transformation to mylofibrosis/acute leukemia, death).

Eligibility criteria: Inclusion Criteria:

* Patients with MPN diagnosis
* Mutation in IDH1/2, SRSF2 or SF3B1

Exclusion Criteria:

* Unable to consent

Primary outcomes:
measure: Event free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT02005445: Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
Official title: Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Coronary Heart Disease
Keywords: Obstructive sleep apnea
Coronary heart disease
Cardiac rehabilitation
Cardiopulmonary exercise testing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-12-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including impact on exercise capacity, disability, and quality of life.

Detailed description: Obstructive sleep apnea (OSA) is a highly prevalent condition in patients with coronary heart disease and is associated with impaired exercise performance, functional limitation and reduced health-related quality of life. The investigators hypothesize that identification and treatment of OSA in patients undergoing cardiac rehabilitation will improve the response to rehabilitation. The proposed study will test this hypothesis using a parallel group, randomized, clinical trial comparing OSA treatment with continuous positive airway pressure (CPAP) to an educational control group in patients undergoing cardiac rehabilitation who screen positive for previously undiagnosed OSA.

Eligibility criteria: Inclusion Criteria:

* Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System.
* Moderate to severe OSA (AHI \>15) on home sleep testing.

Exclusion Criteria:

* Dangerous levels of sleepiness (Epworth Sleepiness Scale score \>16 or a report of falling asleep at the wheel of a car within the past 2 years).
* Physical limitation precluding exercise testing.

Primary outcomes:
measure: WHO Disability Assessment Scale 2 Scores
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Daniel J Gottlieb, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04123145: Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)
Official title: Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: VIFORFRANCE
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Despite its known prevalence, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In patients with Chronic Kidney Disease but Non-Dialysis, the determination of Ferritinemia and Transferrin Saturation Factoris performed in only 30% and 10% of cases whereas they should be performed routinely in inflammatory situations and in case of anemia (HAS 2011, KDIGO 2012). The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients with CKD-ND, applying the international recommendations and those of the French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age;
* Patient present at the hospital on the day of the study (traditional hospitalization, week hospital, day hospital, or in consultation with CKD-ND);
* Diagnosis of CKD-ND (glomerular filtration rate (GFR) \> 15 mL/min/1.73 m²)
* Patient with signed consent

Exclusion Criteria:

* Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant or breastfeeding woman;
* Patient with dialysis

Primary outcomes:
measure: Complete blood iron status
timeFrame: One day
measure: Complete blood iron status
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00451945: New Indications for Ultrasound in the Staging of Cervical Cancer
Official title: New Indications for Ultrasound in the Staging of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-03-26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer.

1. 3-D-ultrasound of the tumour to estimate its volume and local spread
2. Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.


Eligibility criteria: Inclusion Criteria:

* Cervical cancer,
* PET/CT pos. lymph nodes,
* Patients over 18 years old

Exclusion Criteria:

* Pregnancy,
* Lactating,
* Diabetic

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen univercity hospital, Department of Radiology, section of ultrasound
Study officials:
affiliation: Department of radiology, section of ultrasound
name: Michael B Nielsen, MDSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06429345: Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.
Official title: Possible Role of Coenzyme Q10 in Prevention of Contrast Induced Nephropathy in Patients With Acute Coronary Syndrome Undergoing Coronary Angiography With or Without Intervention.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Contrast-induced Nephropathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography.

Detailed description: Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into 2 groups using their computer generated random numbers that group a will receive the coenzyme Q10 in addition to the standard preventive measures and group b will receive only the standard preventive measures without the coenzyme Q10.

Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years or older.
* ST-elevation myocardial infarction (STEMI).
* Non ST-elevation myocardial infarction( NSTEMI).
* Unstable Angina (UA)

Exclusion Criteria:

* Renal transplant patients.
* Preoperative bleeding .
* Intraoperative bleeding or hypotension.
* Patients taking any nephrotoxic medications

Primary outcomes:
measure: Percentage of the Creatinine rise in 1st 48-72 hours in ccu
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university hospitals
city: Cairo
country: Egypt
facility: Ramy Mohamed Mostafa
Study officials:
affiliation: Resident of cardiology department,Ain shams university
name: RAMY Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04537845: Retrospective Analysis of PET Brain Imaging in Chronic Cancer Pain
Official title: FDG PET Imaging Study of Brain Metabolic Change in Chronic Cancer Pain Patient: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pain
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patient with or without cancer pain

Brief summary: Cancer pain deteriorated in quality of life and related with numerous psychosocial problems. Over the one third of cancer patient suffered from moderate to severe cancer pain, even under adequate pain management.

The 18F-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) images can provide quantitative results in clinical oncology. As a functional neuroimaging, the PET evidently provided anatomical activated regions, size, and spatial extent information. In this retrospective study, we use FDG-PET to investigate changes concerning the glucose metabolism in the brain with or without cancer pain.


Eligibility criteria: Inclusion Criteria:

* cancer patient

Exclusion Criteria:

* no brain metastasis

Primary outcomes:
measure: Find the location of brain metabolic changes, pain scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hosipital
Study officials:
affiliation: National Taiwan University Cancer Center
name: Wen-ying Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin WY, Hsieh JC, Lu CC, Ono Y. Altered metabolic connectivity between the amygdala and default mode network is related to pain perception in patients with cancer. Sci Rep. 2022 Aug 18;12(1):14105. doi: 10.1038/s41598-022-18430-2.