louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01038024: Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
Official title: A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: antioxidant supplement
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.

Detailed description: In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Health male or female non-melanoma patients or volunteers
* 18 years or older with a life expectancy greater than 6 months
* Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
* Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
* Must have never smoked or has not smoked for at least 6 months
* Informed of the investigational nature of the study, is able to provide informed consent and has signed thee informed consent form

Exclusion Criteria:

* Patients/healthy volunteers not meeting all of the above selection criteria.
* Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
* Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
* Patients not willing to comply with protocol requirements

Primary outcomes:
measure: To establish a base line level for 5 DNA modifications of White blood cells
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Nathalie Zeitouni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191724: Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
Official title: Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Submassive Pulmonary Embolism
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.


Eligibility criteria: Patients with symptoms of acute pulmonary embolism (PE), without an indication for fibrinolytic therapy but with echocardiographic evidence of right ventricular dysfunction (submassive PE) within 48 hours of onset of symptoms

Inclusion Criteria:

* Clinical symptoms of Pulmonary embolism for less than 48 hours

Exclusion Criteria:

* Patients with symptoms of Pulmonary embolism for more than 48 hours

Primary outcomes:
measure: Number of Participants With Major Bleeding Events
timeFrame: baseline through day 6
Secondary outcomes:
measure: Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
timeFrame: baseline, day 6, day 90
measure: Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)
timeFrame: baseline and day 90 (follow-up)
measure: Difference in Pulmonary Artery (PA) Pressure
timeFrame: baseline, day 6, day 90
Other outcomes:
Locations:
city: Mannheim
country: Germany
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.
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:
citation: Dempfle CE, Elmas E, Link A, Suvajac N, Liebe V, Janes J, Borggrefe M. Endogenous plasma activated protein C levels and the effect of enoxaparin and drotrecogin alfa (activated) on markers of coagulation activation and fibrinolysis in pulmonary embolism. Crit Care. 2011;15(1):R23. doi: 10.1186/cc9968. Epub 2011 Jan 17.
Clinical trial NCT00066924: Spirituality, Religiosity, and Immune Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Depression
Dying Process
Keywords: spirituality
religiosity
immune functioning
psychoneuroimmunology
cytokines
cancer
death
depression
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to determine whether religiosity and spirituality are related to immune functioning, as measured by interleukin-6 blood plasma level, among terminally ill cancer patients.


Eligibility criteria: Inclusion criteria:

* Inpatient at Calvary Hospital
* Diagnosis of terminal cancer
* Score of 20 or above on Mini-Mental State Exam

Exclusion criteria:

* Presence of a psychiatric disorder that would preclude the production of meaningful data

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Calvary Hospital
state: New York
Study officials:
affiliation: Fordham University
name: Barry Rosenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: William Breitbart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClain CS, Rosenfeld B, Breitbart W. Effect of spiritual well-being on end-of-life despair in terminally-ill cancer patients. Lancet. 2003 May 10;361(9369):1603-7. doi: 10.1016/S0140-6736(03)13310-7.
Clinical trial NCT06544824: Accuracy Comparison: Optoelectronic Motion Capture and Markerless System
Official title: Accuracy of Markerless Motion Analysis in Comparison with Optoelectronic Motion Capture System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Children, Adult
Motor Disorders
Keywords: Kinematic
Markerless
OpenPose
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study includes subjects who previously underwent a functional motor assessment using the SMART DX 100 system at the IRCCS Eugenio Medea Institute. The sample comprises both healthy individuals and those with walking difficulties, all aged over 4 years.

Brief summary: The purpose of this study was to assess the Openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements. This analysis used video and optoelectronic motion capture simultaneously recorded. We assessed more of 20 subject with different motor gait impairments

Detailed description: Marker-based Optical motion tracking is the gold standard in gait analysis, but today, markerless solutions are growing rapidly. Treatment of physical impairments could improve if supported with reliable motion capture. Moreover, the use of markerless technology offers numerous advantages for working with pediatric populations under various conditions. In this paper, we assess the Openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements., in a population of children with and without gait impairments. Validating markerless methods can open the way for new motion capture techniques and enhance the accessibility of kinematic measurements and improve the treatment of physical impairments.

Eligibility criteria: Inclusion Criteria:

* Age over 4 years;
* Ability to walk independently without walking aids and/or orthoses.

Exclusion Criteria:

* Inability to walk independently and safely for short distances without walking aids and/or orthoses.

Primary outcomes:
measure: Absolute Error
timeFrame: Through study completion, an average of 1 year
measure: intraclass correlation coefficients
timeFrame: Through study completion, an average of 1 year
measure: cross-correlation coefficients
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
Study officials:
affiliation: IRCCS E.Medea
name: Giuseppe Andreoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755424: GI Symptoms in Infants Fed Goat Milk-based Infant Formula
Official title: Goat Milk-based Infant Formula and the Prevalence of Gastrointestinal Symptoms in Infants: a Real-world-evidence Study from Brazil, Mexico, Russia, and the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stool Assessment
Skin Rash
Urticaria
Regurgitation
Respiratory Ilness
Crying Time in Colicky Infants
Bloating
DIARRHEA, INFANTILE
Constipation
Keywords: gastrointestinal symptoms
CoMiSS
consumer survey
goat milk-based infant formula
Lead sponsor: Ausnutria Hyproca B.V.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 425
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants aged 0-24 months

Brief summary: A cross-sectional observational survey was conducted in Brazil, Mexico, Russia, and The Netherlands by recruiting parents/legal guardians through social media. Gastrointestinal symptoms after introduction of Goat milk-based infant formula (GMF) were questioned using the validated Cow's Milk-Related Symptom Score (CoMiSS®; scoring 0-33), lower scores indicate fewer symptoms. Occurrence of crying, gassiness, eczema, respiratory symptoms and stool consistency were asked retrospectively before and ≥14 days after introduction of GMF.

Detailed description: A cross-sectional observational online anonymous survey on GI symptoms in infants aged 0-24 months fed GMF has been developed and conducted in Brazil, Mexico, Russia, and The Netherlands. The GMF of interest was commercially available Kabrita® stage 1 or 2 (Ausnutria, B.V., the Netherlands). Participants who had purchased Kabrita® were asked to complete a voluntary survey regarding their experience and observation on their infant's GI complaints. No inclusion criteria were set at the time point of sending out the survey. The survey consisted of 30 questions and was online from June 2021 until November 2022. The survey and associated data collection do not meet the criteria for human subject research and therefore approval by an institutional and/or licensing committee is not needed, and participant consent is not required. Participation in the survey was anonymized and completely voluntary.

Eligibility criteria: Inclusion Criteria:

* infants aged 0-24 months
* fed at least once with goat milk-based infants formula

Exclusion Criteria:

* infants aged \>24 months
* taking medication for functional GI disorders

Primary outcomes:
measure: GI symptoms as assessed by the Cow's Milk-Related Symptom Score (CoMiSS®) after introduction of GMF
timeFrame: 14 days
Secondary outcomes:
measure: retrospective assessment GI symptoms before introduction of Kabrita® and improvement minimally 14 days after introduction.
timeFrame: 14 days
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Ausnutria B.V
state: Overijssel
Study officials:
References:
Clinical trial NCT00537524: Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years
Official title: A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prophylaxis of Avian Influenza
Keywords: Bird flu
seasonal influenza vaccine
influenza vaccine
prepandemic vaccine
virus strain with the potential to cause pandemic
toddlers
children
adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 471
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Receipt of Seasonal Influenza Vaccine for season 2007/2008
* Receipt of another vaccine within 3 weeks before and after each vaccination
* Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant
* Children who are in the local recommendation for influenza vaccination due to underlying diseases

Primary outcomes:
measure: safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart
timeFrame: administered 3 weeks apart
Secondary outcomes:
measure: safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1
timeFrame: 12 months after primary immunization
measure: safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies
timeFrame: 12 months after primary immunization
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: University of Tampere Medical School
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 Sep 6.
citation: Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1.
Clinical trial NCT00844324: Bioequivalence Study in Healthy Subjects
Official title: A Single Dose, 2-Period, Cross-over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Candesartan
Bioequivalence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Body mass index (BMI) 19-27 kg/m2 calculated from height and weight at the Screening visit
* Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, Hepatitis B, Hepatitis C and HIV.

Exclusion Criteria:

* History of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the IP), as judged by the Investigator
* Any condition which could modify the absorption of the IPs
* Previous randomisation of treatment in the present study
* History or symptoms and signs of ongoing severe allergic disease/hypersensitivity

Primary outcomes:
measure: PK (Candesartan cilexetil)
timeFrame: Collected at pre-dose and at selected time points; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30 and 36 hours post-dose
Secondary outcomes:
measure: Safety variables (adverse events, ECG, vital signs, safety laboratory)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: James Hainer, MD
role: STUDY_DIRECTOR
affiliation: Parexel
name: Klaus Francke, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03781024: A Subjective Observational Study of Patients Using Medicated Footbath/Footwash Treatment in Podiatry Care
Official title: The Purpose of This Study is to Evaluate the Level of Relief Perceived by Patients Using Medicated Footbath/Footwash With or Without an Oral Medication for the Treatment of: Toenail Fungus Ingrown Toenails Cellulitis Athletes' Foot Pitted Keratolysis Diabetic Ulcers Open Infected Sores Abscesses Joint Infections Wound Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Toenail Fungal Infection
Cellulitis
Pitted Keratolysis
Diabetic Foot Ulcer
Abscess
Lead sponsor: Data Collection Analysis Business Management
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 5000
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-64 years of age male or female, no children, no incarcerated subjects

Brief summary: The purpose of this study is to evaluate the level of relief perceived by patients using medicated footbath/footwash with or without an oral medication for the treatment of podiatry issues.

Detailed description: Footwash/Footbath for treatment of; Toenail fungus Ingrown toenails Cellulitis Athletes' foot Pitted Keratolysis Diabetic ulcers Open infected sores Abscesses Joint infections Wound care

Eligibility criteria: Inclusion Criteria:

Participants must be diagnosed with an ICD10 code indicative of Toenail Fungus, Ingrown Toenail, Cellulitis, Athletes Foot, Pitted Keratolysis, Diabetic Ulcers, Open infected sores, Abscesses, and Joint infections

* Participants must be starting a new regimen of a medicated footwash/foothbath
* Participants must be expecting to receive therapy for at least 12 weeks
* Participants must be between 18 and 64 years of age
* Participants must be able to provide sound verbal informed consent

Exclusion Criteria:

-

Participants must not be a beneficiary of government funded healthcare program (i.e. Medicare, Medicaid, etc.)

• Participants must not have a diagnosis of cancer within the past 5 years

Primary outcomes:
measure: Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring effectiveness and quality of life from 0 to 10
timeFrame: 36 months
Secondary outcomes:
measure: Visual Analogue scales
timeFrame: 36 months
Other outcomes:
Locations:
city: Land O' Lakes
country: United States
facility: DCABM
state: Florida
Study officials:
References:
Clinical trial NCT00765024: Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Official title: Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Strongyloidiasis
Keywords: strongyloidiasis, ivermectin, albendazole
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Atlantic Laboratory Ltd
First posted: 2008-10-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.


Eligibility criteria: Inclusion Criteria:

* Patients with positive strongyloides larva in the stool

Exclusion Criteria:

* Pregnancy
* Lactating women
* Known allergy to any study drug

Primary outcomes:
measure: cure rate
timeFrame: 1 year
Secondary outcomes:
measure: safety
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Yupin Suputtamongkol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suputtamongkol Y, Premasathian N, Bhumimuang K, Waywa D, Nilganuwong S, Karuphong E, Anekthananon T, Wanachiwanawin D, Silpasakorn S. Efficacy and safety of single and double doses of ivermectin versus 7-day high dose albendazole for chronic strongyloidiasis. PLoS Negl Trop Dis. 2011 May 10;5(5):e1044. doi: 10.1371/journal.pntd.0001044.