louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00432627: Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
Official title: An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Hepatic impairment
adults
deferasirox
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.


Eligibility criteria: Inclusion criteria for those with hepatic impairment:

* Physical signs consistent with a clinical diagnosis of liver cirrhosis
* Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
* Otherwise considered healthy

Inclusion criteria for healthy volunteers:

• In good health.

Exclusion criteria for those with hepatic impairment:

* Clinically significant abnormal findings other than hepatic impairment
* Clinical evidence of severe ascites
* History of surgical portosystemic shunt
* Any evidence of progressive liver disease within the last 4 weeks

Exclusion criteria for healthy controls:

* Clinical evidence of liver disease or liver injury
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* Use of any prescription medication within 1 month prior to dosing

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetics of deferasirox and its metabolites
timeFrame: at FPFV and at LPLV
Secondary outcomes:
measure: Safety and tolerability of deferasirox assessed by adverse events
timeFrame: at FPFV and at LPLV
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04159727: Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson
Official title: Gut Microbiota Dysbiosis and Translocation Within Patients Suffering From Diseases Associated With Increased Intestinal Barrier Permeability : IBD and Parkinson
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Parkinson Disease
Keywords: gut microbiota
Bacterial translocation
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Inflammatory bowel diseases (IBD) and Parkinson disease (PD) are complex and multifactorial pathologies. Gut microbiota seems to play an active role. Indeed the digestive microbiota of patients with IBD or PD exhibits different compositions compared with asymptomatic subjects.

Bacterial translocation from gut to blood has been reported.

Detailed description: The investigators designed a case-control study to investigate the digestive microbiota and bacterial translocation during IBD and PD. The investigators want to evaluate gut microbiota bacteria involved in dysbiosis and bacterial translocation during IBD and PD. The investigators want to identify bacterial populations that can serve as biomarkers for clinical practice.

Eligibility criteria: Inclusion Criteria:

* PD patients : age \< or = 60 years
* asymptomatic subjects : no chronic disease
* asymptomatic subjects : no treatment

Exclusion Criteria:

* severe anemia (Hb\<7g/L)
* people who don't read french
* pregnant women
* people treated by antibiotic, probiotic or prebiotic during the 2 month before inclusion
* people with any diagnosed or treated pathology

Primary outcomes:
measure: 16S RNA sequencing in stool sample
timeFrame: 2 years
measure: 16S RNA sequencing in blood sample
timeFrame: 2 years
measure: Stool quantification of key bacteria associated with intestinal barrier permeability.
timeFrame: 2 years
measure: Blood quantification of key bacteria associated with intestinal barrier permeability.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: European Hospital
state: Bouches-du Rhone
Study officials:
affiliation: Hôpital Européen Marseille
name: Philippe HALFON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844727: Coxib-inhibition of Duodenal Polyp Growth in FAP
Official title: Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Duodenal Polyposis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 38
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: Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.


Eligibility criteria: Inclusion Criteria:

* FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria:

* Pregnancy
* Malignancy
* NSAID hypersensitivity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Medicine, Rikshospitalet
Study officials:
References:
Clinical trial NCT00717327: Adolescent Knowledge of Their Medications
Official title: Medication Reconciliation List and Adolescent Functional Health Literacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects' Understanding of Prescribed Medications
Keywords: MRL
Adolescents
Health Literacy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2008-07-17
Enrollment: 384
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents enrolled in an primary care clinc.

Brief summary: Do adolescents know about their medications?


Eligibility criteria: Inclusion Criteria:

* Adolescents between the ages of 12 and 23 who are able to answer questions regarding their prescribed medications (no receptive or expressive disability)

Exclusion Criteria:

* Adolescents outside age range of 12 and 23 who have receptive and/or expressive disability

Primary outcomes:
measure: Subjects' ability to identify name and purpose of medication.
timeFrame: Clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center Adolescent Clinic
state: Texas
Study officials:
affiliation: Brooke Army Medical Center Adolescent Clinic
name: Chistopher C Dillon, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005427: Cohort Study of Respiratory Illness in Early Childhood
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Diseases
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To analyze previously collected data on respiratory illness in early childhood.

Detailed description: BACKGROUND:

The study built on a previous study funded by the Health Effects Institute, a non-profit foundation jointly supported by the U.S. Environmental Protection Agency and vehicle manufacturers. The previous study was a prospective cohort study of nitrogen dioxide (NO2) exposure and respiratory symptoms and illnesses during the first 18 months of life. Between January, 1988 and June, 1990, 1,315 infants were enrolled and then followed with collection of daily respiratory symptom data and serial monitoring of NO2 concentrations in their homes. The full protocol was completed by 823 subjects and a total follow-up experience of over one-half million days was accumulated. Follow-up ended in December, 1991 and analyses related to the study's principal focus, the health effects of NO2, was completed during the fall of 1992.

DESIGN NARRATIVE:

The analyses were directed at the following: 1) Time spent in day-care and the incidence and severity of respiratory illnesses; 2) Breast-feeding and the incidence and severity of respiratory illnesses during the first six months of life; 3) Determinants of wheezing and wheezing illnesses; 4) Determinants of a physician-diagnosis of asthma; 5) Exposure to woodsmoke and incidence and severity of respiratory illnesses; 6) Household demographics, including ethnicity, and incidence and severity of respiratory illnesses; 7) Determinants of the duration of respiratory illnesses; 8) The validity of retrospective parental reports of respiratory illness; 9) Parental perceptions of the risks of indoor and outdoor air pollution; 10) Clinical findings on assessment of ill children in the community.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bosken CH, Hunt WC, Lambert WE, Samet JM. A parental history of asthma is a risk factor for wheezing and nonwheezing respiratory illnesses in infants younger than 18 months of age. Am J Respir Crit Care Med. 2000 Jun;161(6):1810-5. doi: 10.1164/ajrccm.161.6.9903030.
citation: Cushing AH, Samet JM, Lambert WE, Skipper BJ, Hunt WC, Young SA, McLaren LC. Breastfeeding reduces risk of respiratory illness in infants. Am J Epidemiol. 1998 May 1;147(9):863-70. doi: 10.1093/oxfordjournals.aje.a009540.
Clinical trial NCT05630027: A Scalp Lotion Toimprove Sensitive Scalp Syndrome
Official title: Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia
Sensitive Skin
Keywords: alopecia
sensitive skin
prurit
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with mild alopecia and no dandruff

Brief summary: Overall, 100 Caucasian subjects participated in this 6-weeks lasting study, AC5+ was applied daily. All subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. Instrumental assessments included Trans Epidermal Water Loss (TEWL), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. Subjective/Self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). Same assessments were provided by the investigators.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* mild alopecia:
* female: Ludwig type 1
* male: Hamilton III to IV type

Exclusion Criteria:

* Moderate or severe alopecia
* Dandruff

Primary outcomes:
measure: erythema
timeFrame: Baseline
measure: erythema
timeFrame: Day 21
measure: inflammation
timeFrame: Baseline
measure: inflammation
timeFrame: Day 21
measure: greasiness
timeFrame: Baseline
measure: greasiness
timeFrame: Day 21
measure: Global soothing score
timeFrame: Baseline
measure: Global soothing score
timeFrame: Day 21
Secondary outcomes:
measure: pruritus
timeFrame: Baseline
measure: pruritus
timeFrame: Day 21
measure: burning
timeFrame: Baseline
measure: burning
timeFrame: Day 21
measure: stinging
timeFrame: Baseline
measure: stinging
timeFrame: Day 21
measure: scratching
timeFrame: Baseline
measure: scratching
timeFrame: Day 21
measure: hair quality
timeFrame: Baseline
measure: hair quality
timeFrame: Day 21
measure: Transepidermal water loss
timeFrame: Baseline
measure: Transepidermal water loss
timeFrame: Day 21
measure: Inflammation markers
timeFrame: Baseline
measure: Inflammation markers
timeFrame: Day 21
measure: squalene
timeFrame: Baseline
measure: squalene
timeFrame: Day 21
measure: Squalene monohydroperoxide
timeFrame: Baseline
measure: Squalene monohydroperoxide
timeFrame: Day 21
Other outcomes:
Locations:
city: Saint-Ouen
country: France
facility: L'OREAL Research and Innovation
Study officials:
affiliation: L'OREAL Research and Innovation, Saint-Ouen, France
name: Philippe Massiot
role: STUDY_DIRECTOR
References:
Clinical trial NCT02277327: Trial to Reduce Hospitalizations in Children With Medical Complexity
Official title: Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Illness
Keywords: Hospitalization
Readmissions
Medical complexity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators hypothesize that an intervention, within an established patient-centered medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital utilization among medically complex children.

Detailed description: The investigators will pilot test an intervention that includes contingency planning and care transitions within an established medical home program caring for children with medical complexity. Children with medical complexity receiving care within the UCLA Medical Home Program will be randomized to the pilot intervention or usual medical home care. The primary goal will be to reduce admissions and readmissions in the intervention group.

Eligibility criteria: Inclusion Criteria:

* Children ages 0 to 17 years old who are enrolled in the Pediatric Medical Home Program at UCLA
* English and Spanish-speaking only

Exclusion Criteria:

* Children older than 17 years old who are enrolled in the Pediatric Medical Home Program
* Non-English and Non-Spanish speakers

Primary outcomes:
measure: (1) number of all-cause admissions, defined as any admission occurring during the study period
timeFrame: 18 to 24 months
measure: (2) preventable admissions, defined by 2 independent physicians blinded to study assignment as an admission due primarily to one of the preventable factors identified from Phase 1 of the study
timeFrame: 18 to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Thomas Klitzner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205827: A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
Official title: A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: whole blood clotting time
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2014-07-31
Enrollment: 12
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: OTHER

Brief summary: The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.

Detailed description: No investigational product was administered to any subject in this study.

Eligibility criteria: Inclusion Criteria:

1. Signed and dated, written informed consent (Institutional Review Board \[IRB\]-approved informed consent form \[ICF\]).
2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)

Exclusion Criteria:

1. Healthy subjects who do not conform to the above inclusion criteria.
2. Healthy subjects who cannot communicate reliably with the Investigator.
3. History of major bleeding or major trauma within the past 6 months
4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
5. Significant infection or known inflammatory process within 2 weeks of screening.
6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
7. Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin \[ASA\]) with a direct effect on hemostasis within 7 days of testing
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Subjects who are concurrently enrolled in any other clinical study.

Primary outcomes:
measure: Variability in whole blood clotting time measurement
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles Phase I Services, LLC
state: Kansas
Study officials:
affiliation: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
name: James Costin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01689727: Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
Official title: A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pituitary Tumors
Keywords: Pituitary Tumors
Lead sponsor: Endocyte
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a ligand (EC20) designed to bind to the folate receptor. The study is designed as an open-label, baseline-controlled study.

Detailed description: This is a Phase 2 open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of subjects with pituitary tumors with increased uptake of FolateScan in tumors and correlate the immunohistochemical staining findings with the FolateScan images, in subjects with pituitary tumors.

Eligibility criteria: Inclusion Criteria:

Subjects must meet the following eligibility requirements to be enrolled in the study:

1. Subject must be 18 years of age or older.
2. Subject must have a pituitary tumor.
3. Subject must have good kidney function.

3. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

Subjects must be excluded if any of the following conditions are present:

1. Subject is pregnant or breastfeeding.
2. Subject is simultaneously participating in another investigational drug study.
3. Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study.
4. Subject is unable to tolerate conditions for radionuclide imaging.
5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
Study officials:
affiliation: Emory Hospital
name: Nelson Oyesiku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03520127: A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
Official title: A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Lesions
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone the Intact procedure that are female and 18 years of age or older.

Brief summary: The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥ 18 years
* BIRADS ≤ 5, as initially imaged
* Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used

Exclusion Criteria:

* Male
* Subjects with subglandular (pre-pectoral, or "single plane") breast implants
* Subjects with electronic implantable devices (such as pacemakers and defibrillators)
* Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed

Primary outcomes:
measure: Lesion BIRADS score
timeFrame: Weeks prior to the Intact procedure
measure: Imaging lesion size
timeFrame: Weeks prior to the Intact procedure
measure: Lesion histology
timeFrame: Weeks prior to the Intact procedure
measure: Tissue margin (as reported from histology) rate
timeFrame: Weeks after the Intact procedure, up to approximately 12 weeks
measure: Underestimation rate
timeFrame: Weeks after the Intact procedure, up to approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Breast Care
state: Alabama
city: Atlanta
country: United States
facility: Winship Cancer Institute-Emory St. Joseph's
state: Georgia
city: Dalton
country: United States
facility: Dalton Surgical Group
state: Georgia
city: Lithonia
country: United States
facility: Metro Surgical Associates Inc.
state: Georgia
city: Holyoke
country: United States
facility: Holyoke Medical Center
state: Massachusetts
city: Nashville
country: United States
facility: Nashville Breast Center
state: Tennessee
city: Chesapeake
country: United States
facility: The Breast Center at Chesapeake Regional Healthcare
state: Virginia
Study officials:
affiliation: Medtronic Surgical Technologies
name: Lydia Sakakeeny, PhD
role: STUDY_DIRECTOR
References: