louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05082363: The Expression Profile of New Complement Components in Childhood Lupus Nephritis
Official title: The Expression Profile of New Complement Components in Childhood Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Nephritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Age younger than 18 years.

* Active SLE with and without renal affection
* Patients with biopsy proven LN according to ISN/RPS classification criteria of Lupus nephritis.

Brief summary: The aim of this study was to evaluate whether C4d is a better biomarker and examine whether C4d plasma levels correlate with treatment response and C4d kidney deposition in systemic lupus erythematosus (SLE) with lupus nephritis (LN).

Detailed description: Evaluation of C4d in lupus nephritis in children C4d level difference in children with systemic lupus with and without renal affection C4d level in lupus nephritis at activity and after remission Detection of C4d deposition in renal tissue relation to disease activity

Eligibility criteria: Inclusion Criteria:

* This will include children and adolescents who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC)(10) classification criteria of SLE.

  * Inclusion Criteria:

    * Age younger than 18 years.
    * Active SLE with and without renal affection
    * Patients with biopsy proven LN according to ISN/RPS classification criteria of Lupus nephritis.

Exclusion Criteria:

* -Patients in remission.

Primary outcomes:
measure: Evaluation of C4d in lupus nephritis in children
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Martin M, Trattner R, Nilsson SC, Bjork A, Zickert A, Blom AM, Gunnarsson I. Plasma C4d Correlates With C4d Deposition in Kidneys and With Treatment Response in Lupus Nephritis Patients. Front Immunol. 2020 Oct 2;11:582737. doi: 10.3389/fimmu.2020.582737. eCollection 2020.
citation: Bennett M, Brunner HI. Biomarkers and updates on pediatrics lupus nephritis. Rheum Dis Clin North Am. 2013 Nov;39(4):833-53. doi: 10.1016/j.rdc.2013.05.001. Epub 2013 Jul 16.
citation: Kim MK, Maeng YI, Lee SJ, Lee IH, Bae J, Kang YN, Park BT, Park KK. Pathogenesis and significance of glomerular C4d deposition in lupus nephritis: activation of classical and lectin pathways. Int J Clin Exp Pathol. 2013 Sep 15;6(10):2157-67. eCollection 2013.
Clinical trial NCT00000263: Effects of Combined Alcohol and Nitrous Oxide Intake - 15
Official title: Effects of Combined Alcohol and Nitrous Oxide Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
ethanol
drug interaction
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Pain intensity, pain bothersomeness
timeFrame: Post inhalation
measure: Mood
timeFrame: Post inhalation
measure: Psychomotor performance
timeFrame: Post inhalation
measure: Cognitive performance
timeFrame: Post inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04639063: Assessment of Surgically Removed Abdominal Wall Endometriomas
Official title: Clinico-pathological Assessment of Surgically Removed Abdominal Wall Endometriomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis Outside Pelvis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients treated in our hospital and pathologically examined in our hospital

Brief summary: A retrospective review of all patients who underwent surgery for an anterior abdominal wall mass which confirmed by pathology examination as an endometrioma will be completely performed. The clinical data will be recorded and pathology report diagnosis will be correlated with the clinical data to assess the possible causes of endometrioma in the women treated in our tertiary hospital and the efficacy of the surgical excision.

Detailed description: Our hospital is a tertiary center for performing Cesarean sections, external endometriosis (Endometrioma) is a challenging complication for this operation, many treatment choices are available and the most common is the surgical excision, however recurrence could be seen after the surgical operation. We assess all patients who underwent surgical excision for abdominal wall endometriomas in our hospital by retrieving the medical files and pathology reports to study the possible age group,causes and duration of endometriomas. Also the rate of enodmetriomas among the previously experienced females with cesarean section operations. Pathological diagnosis tools will be also assessed.

Ethical approval was obtained from the local committee. Results will be statistically assessed using SPSS programm.

Eligibility criteria: Inclusion Criteria:

* Female
* Surgically removed abdominal wall endometrioma

Exclusion Criteria:

* Male (very very rare to occur)
* medically treated enodmetrioma
* Outside treated patients

Primary outcomes:
measure: Positive for endometrioma
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abdulkarim Hasan
Study officials:
affiliation: Al-Azhar University
name: Abdulkarim Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139863: Chairside Mouthrinse Test and Cost Effectiveness
Official title: Pilot Study on Oral Health Status Chairside Mouthrinse Test in Finnish Adolescents and Cost Effectiveness of the Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis, Juvenile
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim is to study whether participants at risk could be identified using an aMMP-8 chairside mouth rinse test and to study if oral health and health behaviour is linked to the test result in Finnish adolescents.

Detailed description: Adolescents (14-15-year-olds) are randomly divided to control group and test group. Chairside mouth rinse test for aMMP-8 is performed for the test group. Two groups are compared with each other.

Participants are asked to fill a questionnaire which consists of questions concerning oral hygiene habits, tobacco products, alcohol, drug and snuff use.

Eligibility criteria: Inclusion Criteria:

* All 8 class (aged 14-15 years) pupils in Jukola, Hämeenlinna, Finland
* Written informed consent from the participants and their parents (one of them)

Exclusion Criteria:

* No written consent to the study

Primary outcomes:
measure: aMMP-8 test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Anna Maria Heikkinen
state: Helsinki University
Study officials:
References:
Clinical trial NCT06972563: The Effect of Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed With Generalized Anxiety Disorder on Cognitive Avoidance Levels and Coping Attitudes
Official title: The Effect of Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed With Generalized Anxiety Disorder on Cognitive Avoidance Levels and Coping Attitudes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Acceptance and Commitment Therapy
Cognitive Avoidance
Coping Attitudes
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be conducted to determine the effects of acceptance and commitment therapy-based psychoeducation on cognitive avoidance levels and coping attitudes in patients diagnosed with generalized anxiety disorder.

H0: Acceptance and commitment therapy-based psychoeducation has no effect on the cognitive avoidance levels and coping attitudes of patients diagnosed with generalized anxiety disorder.

H1: Acceptance and commitment therapy-based psychoeducation reduces the cognitive avoidance levels of patients diagnosed with generalized anxiety disorder.

H2: Acceptance and commitment therapy-based psychoeducation affects the coping attitudes of patients diagnosed with generalized anxiety disorder.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with generalized anxiety disorder according to DSM-5 diagnostic criteria and receiving outpatient treatment
* Being literate
* Having no problems understanding or speaking Turkish
* Being in the 18-65 age group
* Having not received such training in the last 6 months

Exclusion Criteria:

* Those diagnosed with another comorbid mental illness Patients with a mental condition that makes cooperation impossible, such as intellectual disability or memory impairment
* The illiterate
* Patients who do not consent to be interviewed

Primary outcomes:
measure: Measuring the effect of cognitive avoidance levels of patients diagnosed with generalized anxiety disorder
timeFrame: 1 month
Secondary outcomes:
measure: coping attitudes of patients diagnosed with generalized anxiety disorder
timeFrame: 1 month
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Eğitim ve Araştırma Hastanesi
state: Antakya
Study officials:
References:
Clinical trial NCT03405363: Cardiovascular Events in Chronic Obstructive Pulmonary Disease Patients Initiating Olodaterol or Other Long-acting beta2 Agonists
Official title: Cohort Study of Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease Initiating Olodaterol or Other Long-acting beta2-agonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 65406
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: Examine the risk of cardiovascular events (cardiac arrhythmia or myocardial ischemia) or all-cause mortality in Chronic Obstructive Pulmonary Disease (COPD) patients who are new users of Olodaterol or other LABAs available for the treatment of COPD.

Detailed description: Purpose:

Time Perspective:

Eligibility criteria: Inclusion criteria:

* COPD diagnosis
* aged 40 years or older (to minimise the likelihood of including individuals who have asthma only)
* New user of olodaterol or a new user of indacaterol, salmeterol, or formoterol (not in fixed-dose combination with an inhaled corticosteroid) and have no dispensing of any LABA in the 6 months before the index date
* at least 1 year of enrolment in the electronic database before their first LABA dispensing (defined as the index LABA)
* Complete data on sex

Exclusion criteria:

none

Primary outcomes:
measure: Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Atrial Fibrillation or Flutter (AF)
timeFrame: Up to 4 years and 11 months
measure: Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Supraventricular Tachycardia (SVT) (Other Than Atrial Fibrillation/Flutter)
timeFrame: Up to 4 years and 11 months
measure: Occurrence of First Hospitalisation for Ventricular Tachycardia (VT), Including Ventricular Fibrillation/Flutter and Cardiac Arrest
timeFrame: Up to 4 years and 11 months
measure: Occurrence of First Hospitalisation for Acute Myocardial Infarction (AMI)
timeFrame: Up to 4 years and 11 months
measure: Occurrence of First Hospitalisation for Serious Acute Coronary Heart Disease (SACHD), Including Angina and Other Acute Ischaemic Heart Disease Events
timeFrame: Up to 4 years and 11 months.
Secondary outcomes:
measure: All-cause Mortality.
timeFrame: Up to 4 years and 11 months.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitets hospital Skejby
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06911463: Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for TAVI
Official title: Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for Transcatheter Aortic Valve Implantation (TAVI)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: the aim of the present study is to compare suprainguinal fascia iliaca block and ilioinguinal-iliohypogastric (II-IH) nerve block in improving the quality of conscious sedation, including reducing patients' requirements for analgesia also better satisfaction for both patient and surgeon as regards patient outcome and decreasing the incidence of conversion to general anesthesia during TAVI procedure


Eligibility criteria: Inclusion Criteria:

* aged \>20 years with severe aortic stenosis undergoing elective, non-emergent, non-urgent transfemoral Sapien 3TM (Edwards Lifesciences Corp., Irvine, CA, USA) or CoreValveTM (Medtronic, Minneapolis, MN, USA) implantation were included in the study

Exclusion Criteria:

* younger than 20 years

Primary outcomes:
measure: The primary outcome is the timing to the first rescue analgesia
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
References:
Clinical trial NCT06100263: Breast Cancer Resiliency Through Exercise Program (B-REP)
Official title: Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and a health education control among 60 Black breast cancer survivors.


Eligibility criteria: Inclusion Criteria:

Women will be eligible if they meet the following criteria:

* self-identify as Black or African American or Afro-Latina/e;
* are ≥18 years old;
* have a confirmed diagnosis of breast cancer, Stage I to IIIA;
* have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable;
* are not meeting current cancer-specific resistance exercise guidelines of ≥ 2 times per week; and
* are able to speak and understand English.

Exclusion Criteria:

* metastatic disease;
* medical reason that precludes them from increasing current exercise levels;
* planned elective surgery during study period;
* pregnant or plans to become pregnant during the study period;
* plans to move out of United States during the study period; (the rationale for this exclusion is that it will be difficult to conduct the in-person assessments if a participant leaves the United States);
* current enrollment in another exercise trial; and/or
* inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.

Primary outcomes:
measure: Feasibility of the exercise program (Retention)
timeFrame: up to 24 weeks after start of intervention
measure: Feasibility of the exercise program (Adherence)
timeFrame: 12 weeks after start of intervention
measure: Feasibility of the exercise program (fidelity)
timeFrame: 12 weeks after start of intervention
measure: Satisfaction of program
timeFrame: up to 24 weeks after start of intervention
measure: Affective attitude
timeFrame: up to 24 weeks after start of intervention
measure: Perceived burden
timeFrame: up to 24 weeks after start of intervention
measure: Outcome expectation
timeFrame: up to 24 weeks after start of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Angela Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839863: Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
Official title: Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 10000
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: Breast cancer patients undergoing radiation treatment

Brief summary: Due to better treatment options and earlier detection, survival rates of patients with breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life and the cosmetic outcome are becoming more important. Also, many competing experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are being developed, all in need to be properly evaluated before being implemented in routine clinical care. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard.

By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the investigators aim to:

* provide an infrastructure for efficient, fast and pragmatic evaluation and implementation of experimental interventions
* gain insight into short and long-term treatment response, toxicity, complications, quality of life and survival of patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients with breast cancer who undergo irradiation in the UMC Utrecht
* Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.

Exclusion Criteria:

* Inability to understand the Dutch language

Primary outcomes:
measure: Change from baseline Quality of Life at 10 years
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Helena M Verkooijen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01266863: E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital-acquired Pneumonia
Keywords: Hospital-acquired pneumonia
E test
Antibiogram
Bronchoalveolar lavage
Lead sponsor: Université Victor Segalen Bordeaux 2
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 30
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: To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.


Eligibility criteria: Inclusion Criteria:

* all patients with suspected HAP undergoing BAL will be eligible

Exclusion Criteria:

* contraindications for BAL (PaO2/FIO2 \<100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria \<104 CFU/ml.

Primary outcomes:
measure: Major error defined as the MIC(s) classified as R or I by E test method and S by referent method
timeFrame: 2 days
Secondary outcomes:
measure: Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method
timeFrame: 2 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
citation: Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bebear C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.