louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00030069: Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
Official title: Calcitriol and Dexamethasone for Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: Hematopoiesis
Apoptosis
Cell Differentiation
Bone Marrow Cells
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2002-01-31
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

Detailed description: Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results.

This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.

Eligibility criteria: Inclusion criteria:

* Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS)
* Evidence of cytopenia affecting at least 1 hematological cell lineage
* Adequate liver and renal function
* ECOG 0-2
* Expected survival of at least 12 weeks

Exclusion criteria:

* Symptomatic coronary artery disease
* Uncontrolled diabetes mellitus
* Uncontrolled and symptomatic glaucoma
* History of dangerous reactions to steroid therapy
* Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks
* History of nephrolithiasis
* Children
* Chronic myelomonocytic leukemia (CMML)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01764269: Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014
Official title: Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-01-09
Enrollment: 656
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these vaccines as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.


Eligibility criteria: Inclusion Criteria:

1. are 24 through 59 months of age,
2. have a visit at a study site anytime during the study period,
3. receive first dose LAIV or IIV in the season,
4. the parent has a cell phone with text messaging capabilities, and
5. the parent speaks English or Spanish.

Exclusion criteria:

1. any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record),
2. currently on oral or other systemic steroids or used in the past month,
3. currently on inhaled steroids or used in the past 2 weeks,
4. presence of fever \>=100.4 at time of vaccination,
5. administration of any antipyretic in the 6-hour period prior to vaccination,
6. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
7. parent only speaks a language other than English or Spanish,
8. parent's inability to read text messages,
9. child receiving the second dose of influenza vaccine in the current season.

Primary outcomes:
measure: fever
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Philip LaRussa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199069: German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
Official title: Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Acute Lymphocytic Leukemia
Keywords: ALL
Treatment
De Novo
Adult
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2005-09-20
Enrollment: 720
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',


Eligibility criteria: Inclusion Criteria:

* Acute Lymphocytic Leukemia
* Age 15 - 65 years

Exclusion Criteria:

* Serious secondary diseases which may compromise intensified chemotherapeutical treatment
* Serious psychiatric diseases, which may compromise compliance with therapy
* HIV-1 or HIV-2 Infection
* Pretreatment \> 2 weeks or chemotherapy other than Vincristine and Steroids
* Patients without central diagnosis who cannot be allocated to a risk group

Primary outcomes:
measure: remission rate, disease free survival, overall survival
Secondary outcomes:
measure: death in induction, toxicity, time and dose compliance
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Medical Dept. II
Study officials:
affiliation: University of Frankfurt, Medical Department II
name: Dieter Hoelzer, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01471769: Video Education Intervention in the Emergency Department
Official title: Video Education Intervention in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pediatric
pain
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate if an educational video viewed during the Emergency Department visit will improve parent knowledge of pain management, reduce parent anxiety, and change their use of analgesics at-home after discharge from the Emergency Department.

Detailed description: This study will investigate the use of a video instruction for parents just prior to discharge on pain treatment for their child. The investigators plan to investigate the effect of the video on knowledge because educational modules in the form of videotapes have been shown to be an effective method to improve a parent's knowledge about pain management prior to surgical procedures. Because parental anxiety has a significant impact on a child's experience of pain and video education has been shown to reduce parent anxiety before a procedure, the investigators will also evaluate if parental anxiety is reduced. Whether or not a short video will change the behavior of parents or their satisfaction with the outcome at home has not been investigated and will be an exploratory hypothesis for this study. This research will be a first step towards optimizing the outpatient care for common diagnoses in the Emergency Department.

Eligibility criteria: Inclusion Criteria:

* complaint of pain or injury and laceration, fracture or spring, contusion, crush injuries, head injury, motor vehicle collision, or burn.

Exclusion Criteria:

* non- English speaking parents
* primary caregiver not with child in Emergency Department

Primary outcomes:
measure: Change in parent knowledge from baseline
timeFrame: on day 0 in the ED
Secondary outcomes:
measure: Change in anxiety from baseline
timeFrame: on day 0 in the ED
measure: Pain medication use
timeFrame: assessed on day 0, 1, 2, 3
measure: Child's pain
timeFrame: on day 0, 1, 2, 3
measure: satisfaction
timeFrame: on day 1, 2, and 3
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Amy L Drendel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00252668: Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
Official title: An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 300
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 study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.


Eligibility criteria: Inclusion Criteria:

* Subjects who completed the previous double-blind,randomized study.
* Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.

Exclusion Criteria:

* Dose of prednisone\>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation.
* Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

Primary outcomes:
measure: To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.
Secondary outcomes:
measure: To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Sweden, Denmark and Norway, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Czech Republic, WPPGCLI@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05689268: EUS-PPG vs HVPG in Portal Hypertension
Official title: EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Portal Hypertension
Keywords: EUS
Endoscopic ultrasound
Portal Hypertension
Portal pressure gradient
Hepatic venous pressure gradient
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Undergoing evaluation for chronic liver disease or portal hypertension
* Signed informed consent

Exclusion Criteria:

* Uncorrectable coagulopathy (INR above 1.5)
* Uncorrectable thrombocytopenia (Platelets under 50,000)
* Anticoagulation or antiplatelet therapy that cannot be discontinued
* Biliary obstruction
* Grade II ascites or more
* Intrahepatic portal vein thrombosis
* Pregnancy

Primary outcomes:
measure: Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.
timeFrame: 1 day
Secondary outcomes:
measure: Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.
timeFrame: 1 day
measure: Adverse effects at 30 days after each procedure by clinical follow-up of patients at 24 hours, 7 days, and 30 days using the American Society of Gastrointestinal Endoscopy Severity grading system, from mild to fatal.
timeFrame: 30 days
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Unidad de Endoscopia. Hospital General Universitario de Alicante
Study officials:
References:
Clinical trial NCT04478968: Approach to Vascular Access After Renal Transplantation
Official title: The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Keywords: Arteriovenous Fistula
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a kidney transplant belong to the group of patients at increased risk for cardiovascular disease.

Brief summary: The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.

Detailed description: Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:

* detailed clinical examination
* routine laboratory tests
* lung ultrasound
* muscle strength with a dynamometer
* ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access
* blood collection and protection (10-15 ml) for biomarkers
* survey EQ-5D-5L and LVD-36
* functional strength test.

The obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.

Eligibility criteria: Inclusion Criteria:

* age\> 18 years old
* kidney transplant
* \>12 months after transplantation
* stable transplanted kidney function
* signed informed consent

Exclusion Criteria:

* GFR \<15 ml / min
* severe infection within 3 months of testing
* increase in creatinine concentration\> 0.5 mg / dl within 3 months before the test
* active cancer
* signs of severe heart failure (NYHA IV)

Primary outcomes:
measure: Quality of life with EQ-5D-5L
timeFrame: Baseline visit up to 12 months
measure: Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)
timeFrame: Baseline visit and up to 12 months
Secondary outcomes:
measure: Hospitalization-free survival
timeFrame: Up to 12 months from baseline visit
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Department of Nephrology and Transplantation Medicine
Study officials:
affiliation: Wroclaw Medical University
name: Krzysztof Letachowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270268: Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Official title: Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Gut microbiota
Soluble dietary fiber
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 114
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 purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome

Detailed description: Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.

Eligibility criteria: Inclusion Criteria:

* All patients(age≧18y)
* Admitted for diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

* Mental disorders
* Cancer
* Inflammatory bowel disease

Primary outcomes:
measure: efficacy: change of stool frequency, faecal form and clinical symptoms score
timeFrame: six weeks after inclusion
Secondary outcomes:
measure: efficacy: gut microbiota
timeFrame: six weeks after inclusion
measure: efficacy: cytokine ratios
timeFrame: six weeks after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing PLA General Hospital
name: Tao Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05954468: Psycho-social Impact of Anti-NMDAR Encephalitis
Official title: Psycho-social Impact of Anti-NMDAR Encephalitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NMDAR Antibody-associated Auto-immune Encephalitis
Keywords: auto-immune encephalitis
NMDA receptor encephalitis
Health-related quality of life
psyco-social impact
cognitive consequence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 10
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: This study involves patients with autoimmune encephalitis with anti-NMDAR antibodies.

Brief summary: NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. However, as the disease was only recently discovered (Dalmau and al. Annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated.

The proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. Our main hypothesis is that NMDAR encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. Furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support.


Eligibility criteria: Inclusion Criteria:

* Patients with anti-NMDAR encephalitis
* Year ≥ 18 ans
* Patients affiliated to the social security scheme

Exclusion Criteria:

* Patients with no anti-NMDAR encephalitis
* Minor patient
* Patient under guardianship or curatorship
* Patient with preexisting neurological symptoms

Primary outcomes:
measure: Cognitive and psycho-social analyses of patients with NMDAR encephalitis.
timeFrame: At study completion in an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer
Study officials:
References: