louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06698900: This Project Aims to Understand the Needs of Rheumatologists and Other Specialties in the Care of Patients With SLE
Official title: Generating Evidence Study for Systemic Lupus Erythematosus Using Different Types of Methodologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Rheumatologists
Arthritis
Spondylitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All population data identified in the literature review and desk research; analysis of the National Health Database in Brazil (DataSUS)

Brief summary: The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic. Following this, a discussion among physicians will be facilitated to understand the knowledge gaps among rheumatologists and other specialists regarding SLE. Subsequently, consensus will be sought among a select group of rheumatologists on various aspects related to patient care, unmet medical needs, and implementation of new technologies. Finally, the findings and conclusions from these stages will be used to inform the development and publication of scientific papers.

Detailed description: This study has as geral objective understanding the currently unmet development needs of rheumatologists and other specialists involved in the care of patients with SLE, from a comparative perspective with other rheumatic diseases. The goal is to increase the engagement of these professionals in the discussion and management of patients and sécific objectives, compare the currently available evidence on SLE and three other rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis); Promote discussions to understand the knowledge development needs of rheumatologists regarding SLE; Generate a consensus on the equity of rheumatic diseases in relation to public policies, guidelines, registries, patient association mobilization, patient journey, time to diagnosis, and available medications with access to treatment and, Promote awareness and knowledge through scientific publications about SLE.

Eligibility criteria: Inclusion Criteria:

- All the patients with SLE registered in DataSUS, in the outpatient system (SIA) and in the Hospital System (SIH) from 2019 to 2022

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Understand the difficulties faced by patients with SLE and identify gaps in diagnosis and treatment
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Research Site
Study officials:
References:
Clinical trial NCT01274052: Study of Postprandial Incretin Response in Women With Gestational Diabetes
Official title: Reduced Postprandial GLP-1 Response in Gestational Diabetes Mellitus: a Fully Reversible Phenomenon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational diabetes mellitus
Meal test
Incretin hormones
Glucagon-like peptide-1 (GLP-1)
Glucose-dependent insulinotropic polypeptide
Insulin
C-peptide
Glucagon
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Diabetes Association
name: Aase and Ejnar Danielsens Foundation
name: The Novo Nordic Foundation
First posted: 2011-01-11
Enrollment: 19
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy pregnant woman were examined with a 75 g oral glucose tolerance test. Subjects with plasma glucose (PG) values at 120 min \>9.0 mmol/l were diagnosed with gestational diabetes and subjects with PG \<9.0 mmol/l were enrolled as healthy controls.

Brief summary: The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.

The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Detailed description: The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.

The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Eligibility criteria: Inclusion Criteria:

* Normal haemoblobin
* Willingness to participate

Exclusion Criteria:

* First degree relative with diabetes
* Diabetes before pregnancy
* Positive islet cell- and GAD-65 autoantibodies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Internal Medicine, Glostrup Hospital
Study officials:
affiliation: Diabetes Research Division, Gentofte Hopsital
name: Filip K Knop, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hare KJ, Bonde L, Svare JA, Randeva HS, Asmar M, Larsen S, Vilsboll T, Knop FK. Decreased plasma chemerin levels in women with gestational diabetes mellitus. Diabet Med. 2014 Aug;31(8):936-40. doi: 10.1111/dme.12436. Epub 2014 Apr 1.
Clinical trial NCT03105752: Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers
Official title: Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outcome Assessments (Health Care)
Comprehension
Language
Keywords: Outcome Assessments (Health Care)
Volunteers
Informed consent
Comprehension
Language tests
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent. The willingness to inform patients of all risks and constraints related to research may be in contradiction with the need to write informative and concise documents that are understandable to research participants. As a result, consent forms are long, contain a lot of information and are complicated to understand.

The objective of this study is to evaluate the impact of the readability of the information and consent forms on the understanding of the information received by participants in clinical trials.


Eligibility criteria: Inclusion Criteria:

* Every volunteers included in a study in a french clinical research center
* Ability to read and write in French

Exclusion Criteria:

* Refusal of participation

Primary outcomes:
measure: Correlation between the overall comprehension score and the readability index of Flesch
timeFrame: Immediate evaluation
Secondary outcomes:
measure: Correlation between the overall comprehension score and the level of education
timeFrame: Immediate evaluation
measure: Correlation between the overall comprehension score and the status of volunteer
timeFrame: Immediate evaluation
measure: Correlation between the overall comprehension score and the type of study
timeFrame: Immediate evaluation
Other outcomes:
Locations:
Study officials:
affiliation: Centre d'investigation clinique Paris Est
name: Christian Funck-Brenta, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01986452: Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA
Official title: CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Apoplexy
Keywords: OSA
Apoplexy
CPAP
adherence
telemonitoring
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: Reinhard Löwenstein-Stiftung
First posted: 2013-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor acceptance and adherence. There is a great potential to significantly improve the treatment and care of these patients in a time economic way by telemonitoring the therapy in home environment.

This study is planned to prove that telephone consultancy and motivation in times of recorded decreasing CPAP therapy usage can improve adherence, neurological function and quality of life.

Detailed description: Eligible patients with confirmed OSA from neurological rehab department of Helios Clinic Hagen Ambrock are asked to join the study. They will be randomly assigned to one of two arms \[CPAP with Telemonitoring (MTM) or without Telemonitoring (OTM)\] for 6 months of home treatment after hospital discharge. The MTM arm will receive supporting phone calls when the monitored usage time decreases.

Eligibility criteria: Inclusion Criteria:

* s/p ACM (Arteria Cerebri Media Insult)
* Diagnosed OSA AHI \>15/h
* Barthel Index item 8 \> 5 points (or home assistance)
* Life expectancy \>6 month
* Capable of giving consent

Exclusion Criteria:

* Already existing ventilatory support (CPAP, NIV etc)
* Central AI \>50% baseline
* Central AI \>5/h under CPAP therapy
* Drug abuse
* Pregnant or nursing women
* Participation in another clinical trial last 4 weeks

Primary outcomes:
measure: Adherence to CPAP usage
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen
state: NRW
Study officials:
affiliation: Helios Klinik Hagen
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04446052: Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia
Official title: Phase III Study Priming With rhu_GM-CSF and of Three Induction Regimens in Adult Patients (55 and Over) With Acute Non-Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
First posted: 2020-06-24
Enrollment: 362
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III Study of Priming with Granulocyte-Macrophage Colony Stimulating Factor (rhu-GM-CSF) and ofThree Induction Regimens in Adult Patients (Over 55) with Acute Non-Lymphocytic Leukemia


Eligibility criteria: Inclusion Criteria:

* All patients with acute non-lymphocytic leukemia are eligible for the study.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: complete remission rates
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00239252: Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Interferon alfacon-1
Virus disease
Hepatitis C
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Schering-Plough
First posted: 2005-10-17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of interferon alfacon-1 and ribavirin in hepatitis C patients.


Eligibility criteria: Inclusion Criteria:

* Hepatitis C patients (high titer, genotype1)

Exclusion Criteria:

* Patients with autoimmune disorder
* Patients with negative HBs antigen
* Patients with hepatic cirrhosis, hepatic failure and hepatic cancer
* Patients with depression or psychoneurotic disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Kinki region
country: Japan
city: Kyushu region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Astellas Pharm. Inc.
name: Clinical Development III
role: STUDY_CHAIR
References:
Clinical trial NCT06175052: A Personalized Nutrition Intervention for Adolescent Depression
Official title: A Personalized Nutrition Intervention for Adolescent Depression: A Mixed-Methods Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: adolescents
diet
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 10
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being done to test the feasibility of a personalized nutrition eating plan in adolescents with depression. Evidence suggests that dietary quality may affect an individual's mood. A healthy diet includes vegetables, fruit, nuts, seeds, and olive oil, as well as minimally processed whole grains, legumes, and moderate amounts of lean meat, fish, and dairy.

The investigators will examine the feasibility of a personalized nutrition eating plan for children and youth with depression. Previous research has shown that it helps improve depressive symptoms in adults, but it is not clear if the same is true for children and youth.

Detailed description: The proposed 8-week, mixed-methods, single-arm study aims to examine the feasibility of an adjunctive personalized dietary intervention for adolescents with major depressive disorder. The secondary aims are to determine potential barriers and facilitators of implementation and to improve adherence and uptake.

Eligibility criteria: Inclusion Criteria:

* diagnosis of MDD as determined by semi-structured diagnostic interview
* access to the internet and a computer or smart phone
* presence of a parent who is willing to participate

Exclusion Criteria:

* adherent to a high-quality diet at baseline
* presence of an eating disorder, as determined by semi-structured diagnostic interview
* currently participating in other dietary programs or studies
* actively attempting to increase or decrease body weight;
* presence of a chronic medical condition;
* unstable psychiatric condition (e.g., mania, active suicidal ideation)

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Baseline, 9 weeks
measure: Acceptability of the Intervention
timeFrame: Baseline, 9 weeks
measure: Feasibility, Acceptability, and Satisfaction of the Intervention
timeFrame: Baseline, 9 weeks
Secondary outcomes:
measure: Depression symptoms
timeFrame: Baseline, 5 weeks, 9 weeks
measure: Dietary Assessment
timeFrame: Baseline, 5 weeks, 9 weeks
measure: Nutrition Attitudes and Knowledge questionnaire
timeFrame: Baseline, 9 weeks
measure: Parent Food Modelling:
timeFrame: Baseline, 9 weeks
measure: Satisfaction with menu planning
timeFrame: Baseline, 9 weeks
measure: Satisfaction with nutrition counselling sessions
timeFrame: Baseline, 9 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT01219452: Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
Official title: Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dilated Cardiomyopathy
Keywords: Dilated Cardiomyopathy
Umbilical cord
Mesenchymal stem cells
Children
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.

Detailed description: Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.

Eligibility criteria: Inclusion Criteria:

* Children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail.
* They should have symptoms and /or signs of heart failure, despite optimized medical treatment.
* Ejection fraction of left ventricular should be less than 50%, but more than 20%.

Exclusion Criteria:

* associate coronary artery disease.
* any history or suspicion of a toxic , pharmacologic or deposit etiology.
* associated malignant or pre -malignant systemic disease.
* associated hematologic disorder.
* a history of sustained ventricular tachycardia or fibrillation.
* a history of syncope during the previous year, or with an active infectious disease or positive tests to viral disease.

Primary outcomes:
measure: echocardiography
timeFrame: 3 months
Secondary outcomes:
measure: 24h HOLTER
timeFrame: 2 months
measure: The level of serum BNP,TNI,HGF、LIF and G/M-CSF
timeFrame: 3 months
measure: The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells
timeFrame: 2 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Stem Cell Research Center of Medical School Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: zipu li, MD Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00725452: Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)
Official title: Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-07-30
Enrollment: 26
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: Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.

Brief summary: Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.

Detailed description: This study population was chosen from a non-probability sample.

Eligibility criteria: Inclusion Criteria:

* According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).

Exclusion Criteria:

* According to the European SPC:

  * Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  * Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV).
  * Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients.
  * Subjects with elevated liver enzymes (\>5 upper limit of normal (ULN)).

Primary outcomes:
measure: Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
timeFrame: Maximum 2 years
Secondary outcomes:
measure: Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
timeFrame: Maximum 2 years
measure: Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
timeFrame: Maximum 2 years
measure: Mean Dose of Infliximab
timeFrame: Maximum 2 years
measure: Median Dose of Infliximab
timeFrame: Maximum 2 years
measure: Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab
timeFrame: Baseline and Infusion 9
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02184052: Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory Conditions
Official title: Meloxicam (MOBIC®) Ampoule Post Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions.


Eligibility criteria: Inclusion Criteria:

* Painful acute exacerbations of inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis), painful acute exacerbations of osteoarthritis and other similar conditions requiring acute treatment with an anti-inflammatory drug

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall assessment of degree of pain on a 3-point scale
timeFrame: up to 3 days
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 3 days
Other outcomes:
Locations:
Study officials:
References: