louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00147966: Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
Official title: Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: active disease despite concomitant methotrexate
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-09-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

Detailed description: Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.

Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis
* Use of concomitant methotrexate

Exclusion Criteria:

* Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
* Serious medical conditions that would preclude the use of the treating agent

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 at Week 12
timeFrame: 0 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD CIT
state: California
Study officials:
affiliation: UCSD CIT
name: Arthur Kavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kavanaugh A, Rosengren S, Lee SJ, Hammaker D, Firestein GS, Kalunian K, Wei N, Boyle DL. Assessment of rituximab's immunomodulatory synovial effects (ARISE trial). 1: clinical and synovial biomarker results. Ann Rheum Dis. 2008 Mar;67(3):402-8. doi: 10.1136/ard.2007.074229. Epub 2007 Jul 20.
citation: Rosengren S, Wei N, Kalunian KC, Zvaifler NJ, Kavanaugh A, Boyle DL. Elevated autoantibody content in rheumatoid arthritis synovia with lymphoid aggregates and the effect of rituximab. Arthritis Res Ther. 2008;10(5):R105. doi: 10.1186/ar2497. Epub 2008 Sep 1.
citation: Rosengren S, Wei N, Kalunian KC, Kavanaugh A, Boyle DL. CXCL13: a novel biomarker of B-cell return following rituximab treatment and synovitis in patients with rheumatoid arthritis. Rheumatology (Oxford). 2011 Mar;50(3):603-10. doi: 10.1093/rheumatology/keq337. Epub 2010 Nov 23.
Clinical trial NCT03953066: Colostral Milk and Blood IL-6 Levels in Types of Labour
Official title: The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indications for Care in Pregnancy; Labor; and Delivery
Keywords: melatonin,colostral milk,IL-6, delivery, cesarean section
Lead sponsor: Samsun Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section

Detailed description: In this prospective randomized study, the investigators aimed to show the changes in the melatonin levels in colostral milk in spontaneous vaginal delivery,emergency cesarean and elective cesarean section patients and changes in blood IL-6 level before and after the delivery in same patient groups.

the investigators randomized 30 cases for each group for comparisons.Time range seems short in this study but participating hospital setting is a busy maternity hospital thus it will be performed easily.

The purpose of this study is to demonstrate the beneficial effect of spontaneous vaginal delivery on the secretion of melatonin which is solely secreted by the mother and the newborn is dependent on maternal milk oriented melatonin until 12 th week after delivery

Eligibility criteria: Inclusion Criteria

* Pregnant women reached term
* Patients with spontaneous vaginal delivery
* Patients preferred cesarean section electively
* Patient who had emergency cesarean section without additional medical or surgical problems

Exclusion Criteria

* Women who had history of intrauterine fetal loss
* Hypertention during pregnancy
* Anemia
* Thyroid diseases
* Patients with chronic diseases
* Smokers
* Drug users

Primary outcomes:
measure: The serum IL-6 level
timeFrame: 8 weeks
measure: Colostral Milk melatonin levels in different types of deliveries
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun EAH
state: Outside Of The US
Study officials:
affiliation: Samsun EAH
name: Canan Soyer-Caliskan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05536466: The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Official title: The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Bariatric Surgery Candidate
Keywords: doravirine
pharmacokinetics
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pharmacokinetics of doravirine will be investigated before as well as after bariatric surgery and will be compared for each patient
Primary purpose: TREATMENT

Brief summary: a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.


Eligibility criteria: Inclusion Criteria:

* HIV-infected
* VL suppressed \<40c/ml for at least 6 months, blips are allowed
* planned to have bariatric surgery (gastric bypass or gastric sleeve)
* Able to sign informed consent
* Age \> or equal to 18 years
* Using doravirine for at least 4 weeks prior to BS with VL \< 40 copies/mL prior to the surgery

Exclusion Criteria:

* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation
* Requires or is anticipated to require any of the prohibited medications known to contradict/interact with doravirine
* Has significant hypersensitivity or other contraindication to doravirine
* Creatinine clearance \<40 ml/min
* Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
* Pregnancy or planning to be pregnant during first 6 months postbariatric surgery.

Primary outcomes:
measure: AUC of doravirine
timeFrame: 24 hours
Secondary outcomes:
measure: adverse events
timeFrame: 24 weeks
measure: HIV viral load
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03004066: Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients
Official title: Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Assist Device
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients after heart assist device implantation with wound drainage receiving daptomycin therapy

Brief summary: 10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.


Eligibility criteria: Inclusion Criteria:

* written consent
* heart assist device implantation
* wound drainage
* daptomycin therapy

Exclusion Criteria:

* pregnancy
* no written consent possible
* absence of wound drainage
* allergy to study medication
* acute rhabdomyolysis

Primary outcomes:
measure: levels of Daptomycin in drainage fluid
timeFrame: 4 days
measure: levels of Daptomycin in blood samples
timeFrame: 4 days
Secondary outcomes:
measure: infections
timeFrame: 14 days
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Stefanie Prohaska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00430066: Effects of Imatinib Mesylate in Polycythemia Vera
Official title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycythemia Vera
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2007-02-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.

The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.

Detailed description: Hematocrit \<45% in men or \<42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
* Age \>18 years
* Signed written informed consent form

Exclusion Criteria:

* Pregnancy or breast-feeding
* Creatinine \>3 max NV
* Bilirubin \>3 max NV
* AST/ALT \>3 max NV
* Concomitant and severe psychiatric disorder
* Concomitant neoplastic disease

Primary outcomes:
measure: Reduction of Haematocrit to less than 45%.
timeFrame: 6-12 months
Secondary outcomes:
measure: Response duration
timeFrame: 6-12 months
measure: Safety profile
timeFrame: 6-12 months
measure: Reduction in platelet count and spleen size
timeFrame: 6-12 months
measure: Reduction of incidence phlebotomies.
timeFrame: 6-12 months
measure: Symptoms improvement in patients.
timeFrame: 6-12 months
Other outcomes:
Locations:
Study officials:
affiliation: Divisione di Ematologia - Ospedale Niguarda Ca' Granda
name: Enrica Morra, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06722066: Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
Official title: Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: Scientific Association of Interventional Cardiology - Transcatheter Aortic Valve Replacement (SAINT-TAVR) Calcium Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Lead sponsor: Eunpyeong St. Mary's Hospital
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 19 years or older who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and have voluntarily expressed their willingness to participate through written informed consent.

Brief summary: The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:

Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?

Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 years or older.
2. Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis.
3. Individuals who have voluntarily provided written informed consent to participate.

Exclusion Criteria:

1. Individuals who have not provided written informed consent for this study.

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 years follow-up
Secondary outcomes:
measure: Hospitalization for heart failure
timeFrame: 3 years follow-up
measure: Stroke
timeFrame: 3 years follow-up
measure: Myocardial infarction
timeFrame: 3 years follow-up
measure: Permanent pacemaker insertion
timeFrame: 3 years follow-up
measure: Vascular complication
timeFrame: 30 days follow-up
Other outcomes:
measure: Echo parameters
timeFrame: annual follow-up until 3 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Study officials:
References:
Clinical trial NCT01740466: Epidemiological Profile of Ophthalmological Care in the Public Service in Brazil
Official title: Epidemiological Profile of Ophthalmological Care in the Public Service in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Abnormalities
Keywords: Prevalence
Vision disorders
Eye diseases
Visual acuity
Primary health care
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 1670
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals underwent an ophthalmologic evaluation

Brief summary: Epidemiological study about eye discomfort complaints, comorbidities and diagnosis at a Brazil's ophthalmological public care service

Detailed description: 1. 1670 individuals underwent an ophthalmologic evaluation
2. The data were obtained through the analysis of the medical records with the ICD-10 registration
3. The studied variables were age and sex of patient, origin, eye discomfort complaints, comorbidities and diagnosis (ICD-10).
4. The purpose was to evaluate epidemiological aspects of eye diseases in a public service

Eligibility criteria: Inclusion Criteria:

* Patients assisted in public service

Exclusion Criteria:

Primary outcomes:
measure: Incidence and prevalence of visual conditions in the Public Service in Brazil
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Instituto de Olhos de Goiania
state: Goias
Study officials:
affiliation: IOG
name: Marisa N Figueiredo
role: STUDY_CHAIR
References:
Clinical trial NCT05125666: Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection
Official title: Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ataxia
Medulloblastoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).


Eligibility criteria: Inclusion Criteria:

All children with the following criteria will be in rolled in the study

1. Age range from (5-10 years).
2. Severity of ataxia will be from 15-30 by SARA scale.
3. Children after 2 months of medulloblastoma resection.
4. They can stand and walk with minimal support.
5. They have good cognition, compliance, and ability to understand and instructions.
6. Children receiving radiotherapy and chemotherapy sessions
7. They are medically stable

Exclusion Criteria:

Children will be excluded from the study if they have

1. Any neuromuscular disorder.
2. Visual impairment.
3. Cognitive problem
4. Convulsion.
5. Peripheral neuropathy due to chemotherapy.

Primary outcomes:
measure: Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.
timeFrame: 2 months
measure: Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.
timeFrame: 2 months
measure: Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 57357 Children Cancer Hospital
state: El Sayeda Zainab
Study officials:
References:
Clinical trial NCT04187066: Goal-directed and Cue-dependent Behavior in Severe Obesity
Official title: Goal-directed and Cue-dependent Behavior in Severe Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Behavior
Habits
Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * experimental: severe obesity who might get a bariatric surgery
* control: normal weight

Brief summary: The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight.

Detailed description: Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Bariatric surgery is a very effective procedure to reduce weight fundamentally.

Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. The aim of the current study is to investigate cue-dependent and goal-directed nutritional behavior as well as the effect of a health mindset induction in severe obesity as well as changes in such behaviors due to bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* experimental: severe obesity
* control: normal weight

Exclusion Criteria:

* impaired cognitive functions, which might conflict with the task
* appropriate German

Primary outcomes:
measure: changes in food choice behavior due to substantial weight loss by bariatric surgery
timeFrame: pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Clinic of Tuebingen, fMEG Center
Study officials:
References: