louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05852977: Study of Dengue in Patients With Autoimmune Diseases During the Epidemics of 2020 and 2021 in Reunion Island
Official title: Study of Dengue in Patients With Autoimmune Diseases With or Without Immunosuppressive Treatment During the Epidemics of 2020 and 2021 in Reunion Island
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dengue
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 90
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: Patients with systemic autoimmune disease who have contracted a proven episode of dengue in 2020-21. Only patients followed up at the University Hospital of La Reunion or the Centre Hospitalier Ouest Reunion (CHOR), with or without immunosuppressive treatment will be selected.

Brief summary: It is not known whether there is a different clinical profile of dengue in patients with immune system dysfunction. Preliminary data and previous literature suggest that autoimmune diseases, and in particular their treatment, may favour the evolution to severe forms of dengue.

Our research hypothesis is that the clinico-biological presentation of dengue might be different in case of autoimmune disease, either on the side of overactivation (autoimmune and auto inflammatory diseases without treatment) or immunodepression (autoimmune and auto inflammatory diseases under immunosuppressive treatment).


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Patient with autoimmune or autoinflammatory disease
* Confirmed diagnosis of dengue (in 2020 or 2021): serological test, antigenic test or PCR test to confirm the diagnosis according to current criteria

Exclusion Criteria:

* minor
* opposition to the re-use of data
* patient not followed in Reunion
* protected adult (guardianship or curatorship) or under legal protection

Primary outcomes:
measure: To assess the observed severity of dengue in patients with autoimmune/autoinflammatory diseases.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de la Réunion
name: Loïc RAFFRAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05970198: Helical Tomotherapy in Multiple Myeloma
Official title: A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 58
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: To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.

Detailed description: This study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.

Eligibility criteria: Inclusion Criteria:

1. Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
2. Should agree to comply with all contraceptive requirements; 3, ECOG≤2;

4. Total bilirubin, ALT and AST \<2×UNL (upper limit of normal), BUN \< 30 mg/dL; 5. At least 2 x 10\^6 CD34+ cells /kg were collected; 6.absolute neutrophil count \>1000/uL and a platelet count of \>100,000/uL; 7. The expected survival time is more than 3 months; 8. Written informed consent was obtained from the patients or their immediate family members.

Exclusion Criteria:

Any of the following was an exclusion criterion:

1. According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
2. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
3. patients with uncontrolled or severe cardiovascular disease
4. According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness

Primary outcomes:
measure: Complete response rate and above 100 days after transplantation (≥ CR rate)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 1-year Progression-free Survival rate
timeFrame: 1 year
Other outcomes:
measure: 1-year Overall Survival rate
timeFrame: 1 year
measure: Platelet implantation time
timeFrame: 3 months
measure: Neutrophil implantation time
timeFrame: 3 months
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Fuling Zhou
role: STUDY_DIRECTOR
References:
Clinical trial NCT00158145: Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2
Official title: Longitudinal Study of Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-12
Enrollment: 72
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cigarette smokers

Brief summary: Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.

Detailed description: Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.

Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.

This longitudinal observational study will involve a repeated measure analysis of 6 different tobacco carcinogen biomarkers. Fifty current smokers who intend to continue smoking for the duration of the study will be recruited through advertisements. Participants will be compensated for their time. Blood samples will be collected every two months for one year. All samples will be analyzed for the 6 different carcinogen biomarkers and individual variability in biomarker levels will be assessed.

Eligibility criteria: Inclusion Criteria:

* Currently smokes
* Intends to continue smoking for the 12 months following enrollment

Exclusion Criteria:

* Unstable physical or mental condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06907745: Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis
Official title: Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dentofacial Deformities
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of dentoskeletal disorders

Brief summary: Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Age over 18 and under 60
* Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
* Patients with consent to surgery
* Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination

Exclusion Criteria:

* History of previous maxillomandibular fracture
* Treatment with anticoagulant drugs
* Treatment with intravenous bisphosphonates
* Treatment with anticonvulsants
* Patient's inability to maintain home hygiene standards in accordance with the study requirements
* History of drug and/or alcohol abuse
* Chronic corticosteroid therapy
* Radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years
* Psychosis
* Pregnant or breastfeeding
* Poor compliance
* Endocrinological disorders in poor pharmacological control
* Other uncontrolled systemic conditions that preclude performing surgical procedures

Primary outcomes:
measure: Accuracy evaluation
timeFrame: 1 month post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
References:
Clinical trial NCT03313245: Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study
Official title: Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diet Habit
Cognitive Function
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Dairy Council
First posted: 2017-10-18
Enrollment: 104
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 and 5-year-olds

Brief summary: This study aims to study the relationship between diet and cognitive function among 4-5-year-olds.

Detailed description: Children's ability for optimal cognitive function is critical for their long-term capacity to learn and achieve scholastic success. However, there is a gap in the knowledge pertaining to the selection of appropriate cognitive tasks for studying relationships between diet and cognitive control, particularly among young children. Accordingly, this study aims to study the relationship between diet and cognitive function using a standardized neuropsychological assessment and a modified cognitive task battery.

Eligibility criteria: Inclusion Criteria:

* Parental consent
* Child Assent
* 4 and 5 years of age
* Absence of neurological disorders
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Younger than 4 and older than 5 years of age
* Presence of neurological disorders
* Uncorrected vision

Primary outcomes:
measure: Early Cognitive and Academic Development
timeFrame: Once at laboratory visit
Secondary outcomes:
measure: Attention
timeFrame: Once at laboratory visit
measure: Cognitive Flexibility
timeFrame: Once at laboratory visit
measure: Diet Quality
timeFrame: 7-day average following first laboratory visit
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Department of Kinesiology and Community Health
state: Illinois
Study officials:
References:
Clinical trial NCT03635645: Experimental and Clinical Studies of Retinal Stimulation
Official title: Experimental and Clinical Studies of Retinal Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2018-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.

Detailed description: The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.

Eligibility criteria: Inclusion Criteria:

* Must be implanted with an Argus II Retinal Prosthesis system.
* Have 5 or more electrodes that create a perception with stimulation.
* Must be willing and able to comply with the protocol testing requirements.

Exclusion Criteria:

* Subjects participating in another investigatory drug or device study
* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.

Primary outcomes:
measure: Percent change in stimulus thresholds
timeFrame: Baseline, 8 hours
measure: Change in shape perception
timeFrame: Baseline, 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: James Weiland
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364845: STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
Official title: A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the Short-Form 36 (SF-36) Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Chronic Kidney Disease
Keywords: Quality of Life
Chronic Kidney Disease
Anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-08-16
Enrollment: 51
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks

Detailed description: This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.

Eligibility criteria: Inclusion Criteria:

* Stage 3-5 CKD not on dialysis
* Patients ≥ 70 years of age
* Haemoglobin \< 110g/L at screening
* Transferrin saturation ≥ 15% at screening

Exclusion Criteria:

* Clinical history of type 2 diabetes mellitus
* Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
* Uncontrolled hypertension on two separate measurements during screening
* Use of any erythropoietic protein within 12 weeks of screening

Primary outcomes:
measure: Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
timeFrame: Evaluation Period (Weeks 22-36)
measure: Mean Hemoglobin During the Evaluation Period
timeFrame: Evaluation Period (Weeks 22-36)
measure: Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03410745: Cartilage Adaptation and Response to Interleukins and Exercise
Official title: The Effect of Exercise on the Collagen Synthesis and Cytokine Response in Human Cartilage Tissue With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: exercise
cytokines
collagen
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the effect of exercise on the turnover of collagen in articular cartilage and the content of cytokines in the synovial fluid from human adults with osteoarthritis.

Detailed description: By using stabile isotope labelling, this study will track the formation and destination of newly formed cartilage collagen in adult humans scheduled for knee replacement surgery due to osteoarthritis. The collagen formation as well as the effect on the cytokine content of the synovial fluid will be examined both at rest and in response to 4 weeks of exercise/training. Overall the project aims to improve the basic understanding of cartilage development and function in relation to osteoarthritis prevention.

Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the knee scheduled for knee replacement surgery
* Must be able to perform physical exercise
* Age 40-90 years old
* BMI 18.5-40 kg/m\^2
* None smoker for the last 6 weeks

Exclusion Criteria:

* Regular intake of:
* non steroid anti-inflammatory drugs (NSAID)
* corticoid-steroids
* disease modifying anti-rheumatic drugs (DMARD)
* cytostatic incl. chemotherapy
* immune suppressive medicine
* Inflammatory diseases or cancer
* Recent trauma to the knee (\< 3 months)
* Previous knee surgery
* Regular strenuous exercise ( \> 1 pr. month)
* Previous exposure to tracers (e.g. from another study)

Primary outcomes:
measure: Collagen synthesis in articular cartilage
timeFrame: End of study at 4 weeks
Secondary outcomes:
measure: Cytokine and enzymes concentration in synovial fluid
timeFrame: End of study at 4 weeks
measure: Cytokine and enzymes concentration in blood
timeFrame: At the beginning and at the end of the study at 4 weeks
measure: Gene expression
timeFrame: End of study at 4 weeks
measure: Strength
timeFrame: At the beginning and at the end of the study at 4 weeks
measure: Body mass index (BMI)
timeFrame: At the beginning of the study.
measure: Age
timeFrame: At the beginning of the study.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen
name: Adam EM Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769245: The Effectiveness of ACB-IP 1.0 Convalescent Plasma in COVID-19 Infection
Official title: The Effectiveness of ACB-IP 1.0 Universal Pathogen Free Concentrated Cocktail Convalescent Plasma in COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Acıbadem Labcell
First posted: 2021-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV2 and/or radiologically confirmed pneumonia, were included in the study.

Brief summary: Pathogen-free, concentrated, pooled convalescent plasma has higher SARS-CoV2 antibody titers and neutralizing antibody activities, without requiring blood group compatibility that allows patient accessibility in a shorter time and has safe plasma characteristic.

Detailed description: The efficacy of SARS-CoV2 standard single donor convalescent plasma varied according to the application time and most importantly the amount of antibody that is administered. Single donor plasma has some drawbacks; such as the insufficient levels of neutralizing antibody activities, the requirements of blood group compatibility, and the risk of infection transmission. In this study, the efficacy and safety of pathogen inactivated, isohemagglutinin-depleted (concentrated) and pooled convalescent plasma was investigated.

Eligibility criteria: Inclusion Criteria:

* Are over the age of 60 or-
* Between the ages of 18-60, serious comorbidities (cancer, COPD, cardiovascular illness, hypertension, DM)
* Clinically diagnose COVID-19 or radiological diagnosed COVID-19 pnemonia

Exclusion Criteria:

* Multiple Organ Failure

Primary outcomes:
measure: Mortality Rate
timeFrame: 6 Months
measure: Length of Hospitalization
timeFrame: 6 Months
Secondary outcomes:
measure: Side Effects
timeFrame: 6 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Labcell Cellular Therapy Laboratories
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hospital
Study officials:
References: