louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03156179: Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes
Official title: Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2017-05-17
Enrollment: 22
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teenage girls with type 1 diabetes.

Brief summary: The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the state of the art technique for assessing calcium metabolism in the body and has been used in both healthy and diseased pediatric populations.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of T1D of at least three years duration
* Female sex
* Age between 9-18 years
* Parental/guardian consent and participant assent
* BMI \<99th percentile

Exclusion Criteria:

* History of metabolic bone disease, chronic renal disease, hepatic disease, celiac, or other malabsorptive disease
* History of any proton-pump inhibitor use within a 6 month period prior to enrollment
* History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within a 6 month period prior to enrollment
* Pregnant or lactating females
* Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: fractional calcium absorption
timeFrame: 24 hours
Secondary outcomes:
measure: Estimated calcium retention
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Univeristy of Rochester Medical Center
state: New York
Study officials:
References:
citation: Weber DR, O'Brien KO, Schwartz GJ. Evidence of disordered calcium metabolism in adolescent girls with type 1 diabetes: An observational study using a dual-stable calcium isotope technique. Bone. 2017 Dec;105:184-190. doi: 10.1016/j.bone.2017.09.001. Epub 2017 Sep 4.
Clinical trial NCT02218879: Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
Official title: Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a relapsing form of MS

Brief summary: The primary objective is to directly estimate brain glutathione concentrations in vivo using H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS) patients considering switching therapy or being treatment-naive (first line).


Eligibility criteria: Inclusion Criteria:

* Male or female adult patients
* 18-60 years of age
* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* Patients naive to MS therapy or patients switching from an FDA-approved MS therapy, including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

* Primary progressive multiple sclerosis patients
* Patients with previous exposure or known allergies to fumarates
* MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12
* Contraindications for MRI/MRS
* Known presence of other neurological disorders that may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or intravenous (IV) corticosteroids

Primary outcomes:
measure: Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan
timeFrame: Before and 12 months after Tecfidera Initiation
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Daniel Pelletier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03010579: Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation
Official title: Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anemia
Lymphoma
Hematopoietic Stem Cell Transplantation
Keywords: Anemia
Lymphoma
Hematopoietic stem cell transplantation
Erythropoietin
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 70
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: TREATMENT

Brief summary: This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.

Detailed description: Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.

Eligibility criteria: Inclusion Criteria:

* confirmed lymphoma
* first autologous hematopoietic stem cell transplantation
* hemoglobin level less than 100 g/L on day +15 post-transplant
* written informed consent given by patient or his/her guardian if of minor age.

Exclusion Criteria:

* HIV positive
* Known allergy to recombinant human erythropoietin
* Uncontrolled infection

Primary outcomes:
measure: complete hemoglobin response rate
timeFrame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Secondary outcomes:
measure: proportion of participants with red blood cell transfusions
timeFrame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
measure: proportion of participants with deep vein thrombosis
timeFrame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
References:
Clinical trial NCT00241579: Analgesic Efficacy of Smoked Cannabis
Official title: Analgesic Efficacy of Smoked Cannabis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Hyperalgesia
Keywords: Pain
Cannabis
Analgesic
Lead sponsor: Center for Medicinal Cannabis Research
Sponsor class: OTHER
First posted: 2005-10-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.

Detailed description: It is important to evaluate the effects of the cannabinoids on facilitated pain as conditions of hyperalgesia more closely approximates the clinical situation. There are limited clinical studies on the effect of the cannabinoids on facilitated pain states. Noyes et al evaluated the analgesic effects of Delta-9-THC in 34 cancer patients with pain. They concluded that 20mg of oral Delta-9-THC was similar to 120mg of codeine (Noyes et al, 1975). Jain et al concluded that 1.5-3mg of intramuscular Levonantradol resulted in significant pain relief as compared to placebo in 56 patients with acute postoperative pain (Jain et al, 1981).

Comparison(s): Three different doses of smoked cannabis will be compared to placebo for the reduction of experimentally induced pain.

Eligibility criteria: Inclusion Criteria:

* Age 18-90
* Male or Female
* Subject smoked cannabis within the last six months

Exclusion Criteria:

* Active opportunistic infections or opportunistic malignancies requiring acute treatment
* Active substance abuse (alcohol or injection drug)
* Pulmonary complications (e.g., tuberculosis, asthma)
* Current use of cannabis (e.g., within 30 days of randomization)
* Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition
* Personal or familial history of psychiatric disorder

Primary outcomes:
measure: Score on a Visual Analog Scale (VAS) of pain severity
measure: McGill Pain Questionnaire (MPQ) Short Form
measure: Neurosensory testing of: 1) warm and cold sensation, 2) warm and cold pain, 3) touch, and 4) mechanical pain. Testing administered using a Thermal Sensory Analyzer, von Frey hair filaments, and a pinch algometer, respectively.
Secondary outcomes:
measure: Trail Making Test (TMT) as a measure of psychomotor speed.
measure: Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Mark Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370079: Control Cohort CTRL COH
Official title: Control Cohort CTRL COH
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis
Keywords: Biological collection, control cohort,, new biomarkers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 350
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: Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare disease that could be difficult to diagnose. So it necessary to obtain numerous sample from different disease to develop more specific diagnosis kit It could be possible through the characterisation of new genetic biomarkers.


Eligibility criteria: Inclusion Criteria:

* patient with consent
* patient with following disease: Parkinson's disease, Amyotrophic lateral sclerosis, Glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis.

Exclusion Criteria:

* refusal consent
* patient with neurological disorder compatible with paraneoplastic neurological syndrome or auto-immune encephalitis
* patient under guardianship

Primary outcomes:
measure: Samples (blood dry and EDTA tube and optional cerebro-spinal-fluid)
timeFrame: 15 minutes
Secondary outcomes:
measure: Description of genetic analysis
timeFrame: Data collecting: 3 years Data analysis: 2 years
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France
name: Jerome Honnorat, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342679: A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
Official title: A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Keywords: chronic myeloid leukemia
dasatinib
complete molecular response
Lead sponsor: Kanto CML Study Group
Sponsor class: OTHER
Collaborators: name: Epidemiological and Clinical Research Information Network
First posted: 2011-04-27
Enrollment: 21
Sex: ALL
Minimum age (years): 20
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 evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia


Eligibility criteria: Inclusion Criteria:

* Chronic Myeloid Leukemia in the Chronic Phase
* 20 years old over
* ECOG performance status (PS) score 0-2
* Patients for major molecular response (MMR) with no CMR
* Adequate organ function (hepatic, renal and lung)
* Signed written informed consent

Exclusion Criteria:

* A case with the double cancer of the activity
* Women who are pregnant or breastfeeding
* The case of Pleural effusion clearly
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following

  * have a Myocardial infarction within 6 months
  * have an Angina within 3 months
  * have a Congestive heart failure within 3 months
  * have a suspected congenital QT syndrome
  * have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
* Prior treatment with dasatinib
* Subjects with T315I, F317L and V299L BCR-ABL point mutations

Primary outcomes:
measure: Rate of complete molecular response (CMR) after treatment with dasatinib
timeFrame: at 12 months
Secondary outcomes:
measure: Dasatinib of dose intensity
timeFrame: at 12 months
measure: Expansions rate of large granular lymphocyte
timeFrame: at 12 months
measure: Progression free survival
timeFrame: at 12 months
measure: Number of Participants with Adverse Events
timeFrame: at 12 months
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
state: Tokyo
Study officials:
affiliation: National Hospital Organization, Mito Medical Center
name: Chikashi Yoshida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382784: Psoriasis and the Risk of Cardiovascular Disease. A Prospective Study
Official title: Psoriasis and the Risk of Cardiovascular Disease. A Prospective Observational Study to Detect Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis
Cardiovascular Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have had psoriasis for more than 5 years are being admitted to the study. The assessments include: clinical data, treatment, platelet aggregation and blood viscosity, serum markers and mediators of atherosclerosis, carotid IMT and plaque burden assessed by Color Duplex ultrasound. The patients are recruited from our dermatological department (in and outdoor patients)

Brief summary: There is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. The main goal of this on-going study is to register data which will enable the identification of new markers of atherosclerosis activity and carotid plaque instability in patients with severe psoriasis.


Eligibility criteria: Inclusion Criteria:

* \>18 years old, psoriasis for more than 5 years, moderate to severe psoriasis (PASI \>10 or systemic treatment)

Exclusion Criteria:

* familiar hypercholesterolemia, ongoing infections and cancer disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dermatological Department, OUS
city: Oslo
country: Norway
facility: Oslo university Hospital, Dermatological dept
Study officials:
References:
Clinical trial NCT01581684: Safety Tolerability and Pharmacokinetic of BI 411034
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Number of Participants With Drug Related AEs
timeFrame: From drug administration until end of trial examination, up to 13 days
measure: Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
timeFrame: From drug administration until end of trial examination, up to 13 days
Secondary outcomes:
measure: Maximum Measured Concentration (Cmax )
timeFrame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
measure: Time to Maximum Measured Concentration (Tmax)
timeFrame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
measure: Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
timeFrame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
measure: Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
timeFrame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1308.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT05351684: Effect of Dolutegravir Intensification on HIV-1 Reservoirs
Official title: Effect of Dolutegravir Intensification on Blood and Tissue Latent HIV-1 Reservoirs and on Residual Viremia Despite ART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1-infection
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 20
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: Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal.

The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.


Eligibility criteria: Inclusion Criteria:

* HIV-infected adults receiving cART for at least 3 years
* Undetectable viral for at least 3 years
* DTG/3TC/ABC as cART regimen in the previous 6 months.
* CD4 counts higher than 200 cells per μL

Exclusion Criteria:

* active hepatitis C or B
* unstable liver disease
* renal impairment (estimated glomerular filtration rate \<50 mL per min),
* gastrointestinal disorders that would affect the absorption of study treatment
* current use of drugs with significant interactions with dolutegravir
* current use of drugs with an impact on inflammation such as steroids.
* hospitalization for acute illness within the previous 8 weeks
* Pregnancy or breastfeeding.
* Anal or rectal lesions impeding rectal biopsies
* Decreased platelets count or coagulation disorder.

Primary outcomes:
measure: To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues.
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate the impact of DTG treatment intensification on residual viremia
timeFrame: 3 months
measure: To evaluate the impact of DTG treatment intensification on immune activation
timeFrame: 3 months
measure: To investigate the correlation between blood and tissues HIV reservoir
timeFrame: 3 months
measure: To correlate the concentration of DTG with residual viremia and impact on HIV reservoir
timeFrame: 3 months
measure: To evaluate the impact of DTG treatment intensification on inflammation
timeFrame: 3 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Liège university hospital
Study officials:
References: