louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03939039: From Known to New Genes in Dyslipidemia
Official title: Genetical Characterization of Patients Presenting With Dyslipidemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyslipidemias
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients with dyslipidemia

Brief summary: The mechanism of the majority of the dyslipidemia is multifactorial at the molecular level and remains elusive in more than 50% of the patients in many clinical conditions. Next generation sequencing, a booming strategy, improves the molecular diagnosis efficiency in both monogenic and polygenic dyslipidemia.

In order to decipher the mechanisms involved in the occurrence of dyslipidemia, in addition to the exploration of known candidate genes and Single Nucleotide Polymorphisms (SNP) involved in polygenic modulation, new genes involved in the regulation of lipoprotein metabolism or associated with lipids concentrations need to be sequenced in large groups of dyslipidemic patients.

The goal of this project is to gain new insight into genotype/phenotype correlation.


Eligibility criteria: Inclusion Criteria:

* patients with a family documented history of primary hypercholesterolemia, hypertriglyceridemia, hypobetalipoproteinemia, combined hypolipidemia and combined hyperlipidemia according to the European Atherosclerosis Society and/or published data.
* patients with major secondary dyslipidemia.

Exclusion Criteria:

* inability to provide written informed consent
* lack of legal representative

Primary outcomes:
measure: Genetical exploration in dyslipidemic patients
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est, Département de biochimie et biologie moléculaire Grand Est
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe Moulin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03222739: Ultrasound for Scoliosis Diagnostic Evaluation
Official title: Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis Idiopathic
Scoliosis; Juvenile
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Kitware, Inc.
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2017-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm unblinded group of patients will receive ultrasound imaging of spine.
Primary purpose: OTHER

Brief summary: Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.

Detailed description: All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.

Eligibility criteria: Inclusion Criteria:

* All patients ages 7-17 years who present to Dr. Matthew Oetgen in the Department of Orthopaedic Surgery \& Sports Medicine for clinical evaluation of scoliosis,
* Scoliosis curve type to include adolescent idiopathic (AIS) or juvenile, and
* Have x-rays taken as part of clinical evaluation

Exclusion Criteria:

* Not willing or able to provide consent, or
* Had x-rays taken at an outside facility, or
* Any underlying neuromuscular condition or syndrome and congenital deformities

Primary outcomes:
measure: Imaging
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
References:
Clinical trial NCT00575939: Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV
Official title: Assessment of the Use of a Metabolically-friendly Antiretroviral Regimen to Slow Down the Rate of Progression in Carotid Artery Intima-medial Thickness in Adults With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Atherosclerosis
Keywords: HIV
IMT
coronary
Treatment Naive
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-12-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80 HIV-infected adults older than 18 years of age, ART-naïve with CD4 count of at least 400 cells/mm3

The control group will be adults, healthy controls with no active infection or inflammatory condition, who are matched by gender and age to the HIV positive group

Brief summary: It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.


Eligibility criteria: Inclusion Criteria for HIV positive group:

* HIV-1 infection
* Age at least 18 years
* Naïve to antiretroviral therapy
* CD4 cell count \> 400 cells/mm3

For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications.

Exclusion Criteria (both groups):

* Diabetes
* Pregnant or breastfeeding
* Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period.
* Active infectious or inflammatory condition
* In jail or involuntarily incarcerated

Primary outcomes:
measure: Changes in Carotid IMT
timeFrame: Annualy for 4 years
Secondary outcomes:
measure: Increase or decrease in Inflammatory markers
timeFrame: Annually for 4 years
measure: Changes in Fasting lipids
timeFrame: Annually for 4 years
measure: Change in Insulin resistance by HOMA score
timeFrame: Annually for 4 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University and University Hospitals of Cleveland
name: Grace A McComsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217539: The Swedish Two-County Trial of Mammography Screening
Official title: The Two-County Swedish Mammography Screening Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Ostergotland County Council, Sweden
First posted: 2017-07-14
Enrollment: 133065
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and Ostergotland to find out the impact of early detection on mortality from breast cancer.

Detailed description: The Swedish Two-county study is a randomized controlled trial of invitation to mammography screening. The trial took place in Kopparberg (W), now called Dalarna, and Ostergotland counties in Sweden. The trial randomized 77,080 women aged 40-74 years to invitation to screening (active study population, ASP) and 55,985 women to no invitation to screening (passive study population, PSP). The trial started in 1977 in W-county and in 1978 in E-county. Women in age 40-49 years were invited to single-view mammography screening on average every 24 months, and women aged 50-74 years on average every 33 months. Approximately seven years after randomization a significant 31% decrease in breast cancer mortality was observed in the ASP group, whereupon the PSP was invited to screening once and the screening phase of the trial ended. The mortality data have been reported every two years during the follow-up period and published in peer-reviewed medical journals. The investigators have follow-up data to the Dec 31 2015. The 29-year follow-up data has been published in 2012 in Radiology. Publication of the long-term data reflects the fact that deaths avoided by early detection include some that would have occurred a considerable time later than the screening.

Eligibility criteria: Inclusion criteria

* Female
* Aged 40-74
* No history of breast cancer

Exclusion criteria

• Breast cancer diagnosis prior to randomization

Primary outcomes:
measure: Breast cancer death
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Mammography, Falun Central Hospital
name: Laszlo K Tabar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03710239: OPIOID Study - Pain With Osmotic Dilators
Official title: OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in Second Trimester
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.
Primary purpose: TREATMENT

Brief summary: Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.

Detailed description: This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D\&E) procedures. Pain levels and medication usage will also be assessed following the D\&E procedure itself, up to 7 days after the procedure.

Eligibility criteria: Inclusion Criteria:

* scheduled D\&E for 15+0 to 23+6 wga
* ability to speak and read in English
* ownership of smartphone with internet access and data plan

Exclusion Criteria:

- chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics

Primary outcomes:
measure: Maximum pain above baseline following Laminaria versus Dilapan-S placement
timeFrame: First 24 hours after dilator placement
measure: Time of maximum pain above baseline following Laminaria versus Dilapan-S placement
timeFrame: First 24 hours after dilator placement
Secondary outcomes:
measure: Pain medication use after Laminaria versus Dilapan-S placement
timeFrame: First 24 hours after dilator placement
measure: Maximum pain increase over baseline following D&E procedure
timeFrame: First week after D&E
measure: Pain medication use after D&E
timeFrame: First week after D&E
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Obstetrics and Gynecology
state: New York
Study officials:
References:
Clinical trial NCT00006439: Effects of Home Visits on Medication Adherence in Children and Youth With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-11-06
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.


Eligibility criteria: Inclusion Criteria:

* HIV positive
* English speaking
* Live in Denver metro area
* Taking \>=1 antiretroviral medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
Study officials:
name: Elizabeth McFarland
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232439: A Study of Brain Receptor Occupancy in Healthy Subjects
Official title: Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female
* Have clinical laboratory tests within normal reference ranges
* Have arterial and venous access sufficient to allow blood sampling

Exclusion Criteria:

* Currently enrolled in, or discontinued within the last 30 days from a clinical trial
* History of severe allergies or multiple adverse drug reactions
* Have an abnormal ECG at screening visit
* Have abnormal sitting blood pressure
* Have an increased risk of seizures
* Current suicidal ideation
* Positive test for HIV, hepatitis C, or hepatitis B
* Women who are breast feeding
* Smoke more than 10 cigarettes per day, or equivalent
* Drink more than 5 cups of coffee per day, or equivalent
* Have a history of head injury
* Unable to undergo a MRI
* Suffer from claustrophobia

Primary outcomes:
measure: Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
timeFrame: Baseline, after single dose of study drug
Secondary outcomes:
measure: Pharmacokinetics, area under the curve (AUC)
timeFrame: Days 1 and 2
measure: Number of participants with clinically significant effects
timeFrame: Baseline to study completion
measure: Pharmacokinetics, concentration maximum (Cmax)
timeFrame: Days 1 and 2
Other outcomes:
Locations:
city: New Haven
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Connecticut
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02561039: A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
Official title: Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 97
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 will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults at least 18 years of age
* Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
* Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
* Radiologically confirmed bone disease disease

Exclusion Criteria:

* Previous treatment with ibandronate (Bondronat) within previous 2 months
* Severely impaired renal function
* Known brain metastases

Primary outcomes:
measure: Response rate according to reduction in BPI most acute pain score from Baseline
timeFrame: Month 4
measure: Change in KPI
timeFrame: Baseline to Month 4
Secondary outcomes:
measure: Time to onset of decrease in most acute pain score
timeFrame: Up to 4 months
measure: Analgesic consumption according to participant diary
timeFrame: Up to 5 months
measure: Incidence of adverse events
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: Bourgas
country: Bulgaria
city: Haskovo
country: Bulgaria
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Varna
country: Bulgaria
city: Vratza
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT03896139: Identification of PAthways of Kinase Inhibitors TOxicity
Official title: Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kinase Inhibitors Toxicity
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2019-03-29
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with kinase inhibitors or drugs targeting kinase pathways for a cancer with at least one report accessible in the VUMC electronic health record database and/or in VigiBase, the WHO's international pharmacovigilance database.

Brief summary: The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.


Eligibility criteria: Inclusion Criteria:

* Patient treated with a kinase inhibitor
* Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase

Exclusion Criteria:

-

Primary outcomes:
measure: Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity
timeFrame: population included in VUMC database and/or WHO's database resource up to march 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Study officials:
References: