louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04920721: Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy
Official title: Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Allergy
Keywords: immediate hypersensitivity
platinum salts
skin tests
tolerance induction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with suspected immediate hypersensitivity reactions to platinum salts

Brief summary: To assess the efficacy of skin tests with platinum salts in patients suspects with immediate hypersensitivity reactions.

All patients adressed in consultation to the Allergy Department of university hospital of nancy for an immediate hypersensitivity reaction to platinum salts between 2015 and 2021 were retrospectively recruited.


Eligibility criteria: Inclusion Criteria:

* adult
* suspected immediate hypersensitivity reaction to platinum salts

Exclusion Criteria:

* skin tests not achievable

Primary outcomes:
measure: Result of skin test
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
state: Vandoeuvre-Lès-Nancy
Study officials:
affiliation: CHRU Nancy
name: Tania ADAM, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02134821: Influence of Pain Sensitivity on Lumbar Surgery Outcomes
Official title: Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 171
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The inclusion criteria were the following: 1) patients aged 40-80 years; 2) an lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013

Brief summary: Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.


Eligibility criteria: Inclusion Criteria:

1. patients aged 40-80 years
2. lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013

Exclusion Criteria:

* a history of major psychiatric disorders (schizophrenia, major depression) or peripheral vascular disease
* any concurrent serious medical condition that would cause disability or decreased general health status such as sepsis or cancer.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: up to 12 months after operation
Secondary outcomes:
measure: Visual Analog Pain Scale for back pain
timeFrame: up to 12 months after operation
measure: Visual Analog Pain Scale for leg pain
timeFrame: up to 12 months after operation
measure: Short-Form 36
timeFrame: up to 12 months after operation
Other outcomes:
Locations:
city: Sung-Nam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin S. Yeom, MD
role: STUDY_DIRECTOR
References:
citation: Kim HJ, Park JW, Kang KT, Chang BS, Lee CK, Kang SS, Yeom JS. Determination of the Optimal Cutoff Values for Pain Sensitivity Questionnaire Scores and the Oswestry Disability Index for Favorable Surgical Outcomes in Subjects With Lumbar Spinal Stenosis. Spine (Phila Pa 1976). 2015 Oct 15;40(20):E1110-6. doi: 10.1097/BRS.0000000000001023.
Clinical trial NCT02376621: Bioavailability of Omega-3 Food Supplements in Healthy Subjects
Official title: Nutrition Products - An Open-Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of Omega-3 Based Dietary Supplements Under Fasting Conditions in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: omega-3 based dietary supplements
Bioavailability
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.


Eligibility criteria: Inclusion Criteria:

* males or females
* any ethnic origin
* age 40 - 65 years
* BMI 18.5 - 30.0 kg/m2
* generally in good health
* signed informed consent

Exclusion Criteria:

* males or females not willing to use appropriate contraception
* prescribed systemic or topical medication taken within 14 days
* taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
* taken any medication including St. John's Worth known to alter drug absorption within 30 days
* subjects participating in a clinical study past 3 months
* recent blood donation
* significant history of drug allergy or any allergic disease
* allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation.
* high consumption of tobacco
* high consumption of alcohol
* other significant medical history or physical findings (including HIV,hepatitis)
* vegetarians
* not willing to follow dietary restrictions
* frequent migraine attacks
* previously taken part in or withdrawn from study or according to investigator should not participate.

Primary outcomes:
measure: Area under curve of omega-3 based dietary supplements under fasted conditions.
timeFrame: Pharmacokinetics up to 36 hours postdose
measure: Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.
timeFrame: Pharmacokinetics up to 36 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Study officials:
affiliation: Covance Clinical Research Unit (CRU) Ltd.
name: Ashley Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01999621: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure
Official title: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: organ failure
intensive care
palliative care
patient's wishes
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 140
Sex: ALL
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: Each lung cancer patient with organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included

Brief summary: Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

Detailed description: Two hundred patients have to be enrolled in 2 years in the Grenoble Teaching Hospital and in the Saint Louis hospital in Paris between November 2010 and November 2012. Each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included.

The objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Eligibility criteria: Inclusion Criteria:

* lung cancer
* Organ failure

Exclusion Criteria:

-

Primary outcomes:
measure: Identify an association between patients' characteristics and proposition for intensive care unit admission.
timeFrame: at day 0
Secondary outcomes:
measure: Identify an association between patients' characteristics and decision of intensive care unit admission among patients proposed for ICU admission
timeFrame: at day 0
Other outcomes:
measure: identify patients' characteristics associated with survival
timeFrame: up to 4 months after the last inclusion
measure: patients' feelings according to intensity of care they received
timeFrame: at 3 months
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: TIMSIT Jean-François, PU/PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700921: Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Lovastatin as a Potential Modulator of Apoptosis in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test whether lovastatin helps to modify lung inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).

Detailed description: The impact of lovastatin, 40mg by mouth once daily on biological and clinical outcomes will be evaluated in an exploratory 16-week comparative treatment efficacy trial in 44 adult former smokers with established COPD of moderate severity. This trial employs a longitudinal randomized, parallel-arm, double-blind, placebo-controlled design using biomarkers of airway inflammation as the primary outcomes of interest.

Eligibility criteria: Inclusion Criteria:

1. Adult (≥45 years) former smokers with ≥ 10 pack-years of cigarette smoking
2. FEV1/FVC ratio \< 70%
3. Post-bronchodilator FEV1 between 50% and 80% of predicted if undergoing bronchoscopy, or between 30% and 80% of predicted if undergoing induced sputum only
4. DLco/VA \< 80% predicted
5. Ability to perform and adhere to study protocol
6. ability to provide informed consent.

Exclusion Criteria:

1. Asthma or other comorbid lung disease,
2. Hypoxemia (PaO2 \< 55 mmHg or SpO2 \< 88% on room air), if undergoing bronchoscopy
3. Exacerbation of COPD within the last 6 weeks
4. Upper or lower respiratory tract infection within the last 6 weeks
5. Current smoking
6. Significant coronary artery disease as reflected by unstable angina, myocardial infarction or angioplasty/stenting/bypass surgery within 6 months
7. Current use of HMG-coA-reductase inhibitors
8. Current use of inhaled corticosteroid
9. Concurrent use of other Cyp3A4 (isoform of cytochrome P450) inhibitors
10. History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis)
11. For patients undergoing bronchoscopy, any contraindication to fiberoptic bronchoscopy or conscious sedation, including abnormalities of the platelet count, prothrombin time or partial thromboplastin time.

Primary outcomes:
measure: To determine the effects of lovastatin on apoptosis and efferocytosis in pulmonary macrophages.
timeFrame: 5 years
Secondary outcomes:
measure: To determine the effects of lovastatin on COPD phenotypic variables including lung function, exercise performance, clinical status and quality of life.
timeFrame: 5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
Study officials:
affiliation: National Jewish Health
name: E Rand Sutherland, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583621: Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
Official title: Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 74
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.

Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.


Eligibility criteria: Inclusion Criteria:

1. African-Americans (blacks)
2. Age 13-45
3. Overweight/obese (BMI ≥ 85th percentile for their age and gender for age 13-17 and BMI ≥ 25 kg/m2 for age 18-45)
4. Relatively healthy (no medical history of any heart, lung, endocrine or malignant disorder)
5. Non pregnant
6. Not on any medication or vitamin supplements that can influence the study outcomes
7. Serum 25 hydroxy Vitamin D (25\[OH\] D) levels ≤ 20 ng/ml (50 nmol/L) at the time of screening

Exclusion Criteria:

1. Not meeting any one or more of the above criteria
2. Females who become pregnant/test positive on urine pregnancy test during the screening or any of the testing visits
3. Anyone who is taking any multivitamin supplements that contains vitamin D

Primary outcomes:
measure: Cardiovascular phenotypes
timeFrame: 16 weeks
measure: Primary outcome 1 dose-responsive effects of vitamin D3 supplementations
timeFrame: 16 weeks
measure: Primary Outcome 2 dose-responsive effects of vitamin D3 supplementations
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: Augusta University
name: Yanbin Dong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhagatwala J, Zhu H, Parikh SJ, Guo DH, Kotak I, Huang Y, Havens R, Pham M, Afari E, Kim S, Cutler C, Pollock NK, Dong Y, Raed A, Dong Y. Dose and time responses of vitamin D biomarkers to monthly vitamin D3 supplementation in overweight/obese African Americans with suboptimal vitamin d status: a placebo controlled randomized clinical trial. BMC Obes. 2015 Jul 4;2:27. doi: 10.1186/s40608-015-0056-2. eCollection 2015.
Clinical trial NCT03746821: Biotin Sample Collection Study
Official title: Biotin Urine Collection Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Biotin Excretion
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This protocol has been designed for a collection of urine samples from volunteers who will be given high dose biotin supplements over a period of 5 days, in order to provide a research sample bank to examine for biotin excretion rates

Detailed description: This is a sample collection study from a minimum of 10 volunteers who will be required to take a Biotin supplement daily for a period of 5 days.

Each volunteer will be asked to read the volunteer information sheet and if they wish to participate in the study, the study admission form will be completed and the volunteer will be asked to sign a consent form.

After informed consent each volunteer will be assigned a unique volunteer number for the duration of the trial to provide anonymity. The volunteer will be provided with a daily diary, urine collection material and a full set of volunteer instructions.

The daily diary will collect the following information;

* Date
* Whether or not supplement was taken and time taken
* sample collection times during the day

Volunteers will be requested to:

Day 1: Collect a urine sample from every void during the day. Days 2-6: Take biotin supplements with their evening meal and collect a urine sample from every void during the day Day 7: Collect a urine sample from every void during the day

All samples will be stored in the SPD Bio-bank until required for analysis.

Eligibility criteria: Inclusion Criteria:

* Willing to take biotin supplements and collect urine samples
* Has regular menstrual periods
* SPD employee or partner of SPD employee

Exclusion Criteria:

* Taking any other supplements or medication (other than contraceptive pill)
* Taken Antibiotics in the last 4 weeks
* Diagnosed with metabolic disorder, kidney or liver disease
* Known Pregnancy or seeking to conceive
* Breast feeding
* Undergoing medical investigation for hormone imbalance
* Condition that contra-indicates pregnancy
* Condition that contra-indicates use of biotin supplements

Primary outcomes:
measure: Biotin excretion
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development company Ltd.
name: Sarah Johnson, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01536821: PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study of LRRK2 (Leucine-rich Repeat Kinase 2)
Official title: PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson disease
Parkinson's Disease
PD
LRRK2
genetics
genes
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2012-02-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must provide test results documenting a LRRK2 mutation.

Brief summary: The PROGENI Family Study is part of a larger consortium that is studying a gene shown to be important in Parkinson's disease, called LRRK2. People who have a defect in the LRRK2 gene will often develop Parkinson's disease. Eligible participants will be asked to complete a single Study Visit at an affiliated research facility closest to their home.

Detailed description: Participants will be asked to complete a family history questionnaire, which will gather information about their family history of Parkinson's disease and related disorders. They will be asked to complete a single Study Visit, during which they will be asked to do some or all of the following:

1. Complete questionnaires regarding Parkinson's disease symptoms, medical history, mood, sleep, mental status, and activity level.
2. Be given a brief standard neurological examination.
3. Be given a scratch and sniff smell identification test.
4. Be asked to give a sample of approximately 2 tablespoons of blood.
5. Be asked to give a urine sample of approximately 1 tablespoon of urine.

Eligibility criteria: Inclusion Criteria:

Positive for a LRRK2 mutation

Primary outcomes:
measure: Observation and biological specimen collection
timeFrame: 1 time
Secondary outcomes:
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Indiana University
name: Tatiana Foroud, PhD
role: PRINCIPAL_INVESTIGATOR
References: