louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03531229: Single Ascending Dose Study of Lu AF76432 in Healthy Young Men
Official title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF76432 in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-05-21
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men


Eligibility criteria: Inclusion Criteria:

-Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.

Exclusion Criteria:

* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
* The subject has taken any investigational medicinal product \<3 months prior to the first dose of IMP

Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events
timeFrame: From dosing to 12 days
Secondary outcomes:
measure: AUC0-t
timeFrame: From dosing to 72 hours post dose
measure: Cmax
timeFrame: From dosing to 72 hours post dose
measure: AUC0-inf
timeFrame: From dosing to 72 hours post dose
measure: CL/F
timeFrame: From dosing to 72 hours post dose
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Parexel Early Phase Clinical Unit
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03691129: Yoga Efficacy and Bioactive Materials in the Blood of Korean Elderly
Official title: The Studies of Yoga Efficacy and Bioactive Materials in the Blood of Korean Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Yoga
Healthy Elderly
Lead sponsor: Wonkwang University
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is conducted to verify the relationships between yoga efficacy and bioactive materials in the blood of Korean elderly.

Detailed description: Glycoproteomics approach will be applied to verify the relationships between yoga efficacy and bioactive materials in the blood of Korean elderly.

Eligibility criteria: Inclusion Criteria:

* The elderly group participant over 60 years old.
* The young group participant over 20 to 57 years old.
* Individual who can read and understand Korean.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Participant who was diagnosed with cancer in the last five years.
* In case of participants leaving the yoga program after the primary blood collecting, they will be excluded from the secondary blood collecting.
* Individuals who are judged inappropriate for the study.

Primary outcomes:
measure: Measuring the number of glycoproteins in blood between before and after participation in an elderly yoga program for both the Advanced group and Beginner group
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang University
state: Jeonbuk
Study officials:
affiliation: Wonkwang University
name: Wonryeon Cho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01221129: Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
Official title: Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zinc Deficiency
Keywords: zinc
reticulocyte
PBMC
whole blood
transcriptome
microarray
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-10-14
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UF campus community

Brief summary: The specific aim of this protocol is to examine differential expression of specific mRNAs and proteins that occur when the dietary intake of zinc is acutely reduced below the dietary requirement for a period of ten days.

Detailed description: Methods to assess the dietary zinc status of individual humans or populations are lacking. The study is a three period observational study of biomarkers of zinc status before, during and after zinc depletion. The entire dietary study will take 24 days composed of three parts:

* Dietary Acclimation (Phase 1): 7 days
* Dietary Zinc Restriction (Phase 2): 10 days
* Dietary Zinc Repletion (Phase 3): 7 days

The dietary treatments and all blood draws will be carried out in the General Clinical Research Center (GCRC) at University of Florida. Previous research from has shown that both metallothionein gene expression and specific zinc transporter genes in blood leukocyte subsets are directly proportional to dietary zinc intake. By using cDNA array analysis and quantitative PCR technology with blood RNA, those genes most sensitive to zinc nutrition will be identified for the purpose of developing zinc status assessment methods on how zinc functions in human biology.

Additionally, buccal mucosal cells will be collected in the GCRC by using swabs, i.e., in a noninvasive manner, to further characterize the expression pattern of the genes under study. This method has the potential for nutrition studies in the field (international nutrition, etc).

Eligibility criteria: Inclusion Criteria:

* Healthy male
* 21-35 years
* Body weight above 110 lb

Exclusion Criteria:

* Use of dietary supplements
* Smoker
* Alcoholic
* Under medication
* History of chronic disease
* Use of denture cream
* Vegetarian
* Food allergy

Primary outcomes:
measure: Serum zinc concentration
timeFrame: 24 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Robert J Cousins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryu MS, Guthrie GJ, Maki AB, Aydemir TB, Cousins RJ. Proteomic analysis shows the upregulation of erythrocyte dematin in zinc-restricted human subjects. Am J Clin Nutr. 2012 May;95(5):1096-102. doi: 10.3945/ajcn.111.032862. Epub 2012 Mar 28.
Clinical trial NCT05570929: LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration
Official title: Observation of Alterations in Kidney Function, Immune System and Gut Mircobiota After Living Donor Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Keywords: Short chain fatty acids
Shannon-Index
Microbial diversity
Home sampling
Kidney transplant
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease

Brief summary: This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.


Eligibility criteria: Inclusion Criteria:

* Body-Mass-Index 18,5 - 34,9 kg/m2
* Planned living kidney donation / transplantation

Exclusion Criteria:

* Clinically relevant heart, lung, liver, and kidney diseases
* Postoperative phase
* Acute infections
* Vegan diet
* Change of body weight of more than 10% in the month prior to study entry
* Known drug or alcohol abuse

Primary outcomes:
measure: Fecal microbiome taxonomy (Shannon-Index)
timeFrame: Change from Baseline at 24 weeks
Secondary outcomes:
measure: Functional capacity of gut microbiota
timeFrame: Change from Baseline at 24 weeks
measure: Frequency of circulating T-cell subtypes
timeFrame: Change from Baseline at 24 weeks
measure: Serum tryptophan metabolites concentration
timeFrame: Change from Baseline at 24 weeks
measure: Serum short-chain fatty acid concentration
timeFrame: Change from Baseline at 24 weeks
measure: Fecal tryptophan metabolites concentration
timeFrame: Change from Baseline at 24 weeks
measure: Fecal short-chain fatty acid concentration
timeFrame: Change from Baseline at 24 weeks
measure: Office systolic blood pressure
timeFrame: Change from Baseline at 24 weeks
measure: Office diastolic blood pressure
timeFrame: Change from Baseline at 24 weeks
measure: Body fat content
timeFrame: Change from Baseline at 24 weeks
measure: Fat free mass
timeFrame: Change from Baseline at 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Nicola Wilck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Hendrik Bartolomaeus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Anja Mähler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384629: PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
Official title: PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Bifurcation Lesions
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures,
* Patients ≥ 19 years old,
* Patients who are expected to undergo PCI for bifurcation lesions.

Exclusion Criteria:

* Age\> 85 years,
* Cardiogenic shock or unstable patients,
* Increased risk of bleeding, anemia, thrombocytopenia,
* A need for oral anticoagulation therapy,
* Pregnant women or women with potential childbearing,
* Life expectancy \< 1 year.

Primary outcomes:
measure: Late loss of side branch(SB)
timeFrame: 9 months after procedure
Secondary outcomes:
measure: Cardiovascular (CV) death
timeFrame: 9 months after procedure
measure: Myocardial infarction (MI)
timeFrame: 9 months after procedure
measure: stent thrombosis (ST)
timeFrame: 9 months after procedure
measure: SB closure
timeFrame: 9 months after procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02271529: Zilver PTX Delivery System
Official title: Zilver Paclitaxel(PTX) Thumbwheel Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: Peripheral Vascular Disease
Femoral Artery
Drug-Eluting Stent
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-10-22
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: TREATMENT

Brief summary: The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.


Eligibility criteria: Inclusion Criteria:

* Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
* Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

* Patient is \< 18 years of age
* Patient unable to complete required follow-up assessments
* Patient unwilling to sign and date the informed consent
* Simultaneous participation in another investigational drug or device study
* Pregnant, breastfeeding or planning to become pregnant in the next 5 years
* Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

Primary outcomes:
measure: Mean Percent Change in Stent Length Upon Deployment
timeFrame: Immediately following completion of the stent placement procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Frankston
country: Australia
facility: Frankston Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
Study officials:
affiliation: Auckland District Health Board
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01574729: Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Official title: Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: p53 gene therapy
non-small cell lung cancer
post-surgery
chemotherapy
Lead sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 120
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: The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.

The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.


Eligibility criteria: Inclusion Criteria:

* historically diagnosed advanced non-small lung cancer
* has surgery indication
* age 18 years old or greater
* life expectancy greater than 12 weeks
* ECOG: 0-2
* no prior chemotherapy, radiotherapy in 2 weeks
* Neutrophils≥1.5×10\^9/L,platelet≥80×10\^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range
* subject provides signed informed consent

Exclusion Criteria:

* hypersensitive to study drug
* with a coagulational test unnormal or a bleeding disorder
* infections
* with serious condition which can't stand a surgery
* pregnant or lactating
* principle investigator consider not suitable

Primary outcomes:
measure: overall survival
timeFrame: 3 year after the treatment
measure: adverse effects
timeFrame: from starting treatment to 30 days after treatment
Secondary outcomes:
measure: local recurrent rate
timeFrame: 3 years
measure: quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of Surgery Research, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Institute of Surgery Research, Daping Hospital, Third Military Medical University
name: Qunyou Tan, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04394429: Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation
Official title: Analysis of Events of Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Keywords: Endotracheal Tube
ETT
Intubation
Mechanical ventilation
Endotracheal tube obstruction
ICU
Covid-19
SARS-CoV-2
ARDS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with COVID 19 hospitalized in the intensive care unit at the NHC of the University Hospitals of Strasbourg

Brief summary: The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.


Eligibility criteria: Inclusion Criteria:

* Major Subject (≥18 years)
* Subject with COVID 19 (radiological suspicion or microbiological confirmation)
* Subject hospitalised in the intensive care unit at the NHC of the University Hospitals of Strasbourg between 01/03/2020 and 03/04/2020.
* Subject treated by mechanical ventilation
* Subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research

Translated with www.DeepL.com/Translator (free version)

Exclusion Criteria:

* Subject who expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguarding of justice

Primary outcomes:
measure: Analysis of risk factors for intubation tube obstruction
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil
Study officials:
affiliation: Anesthesia-Resuscitation Department - Strasbourg University Hospitals
name: Bob HEGER
role: STUDY_DIRECTOR
References:
Clinical trial NCT00127829: Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
Official title: A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Solid Tumors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-08-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists
* Life expectancy of \> 12 weeks
* World Health Organization (WHO) performance status of \< 2

Exclusion Criteria:

* Known severe hypersensitivity to gefitinib or any of the excipients of this product
* Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)
* Incomplete healing from previous oncologic or other major surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
Study officials:
References:
Clinical trial NCT02116829: Is There Room for Butter in a Healthy Diet?
Official title: Is There Room for Butter in a Healthy Diet? - A Randomized Controlled Dietary Human Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
First posted: 2014-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols).

The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-CRP.


Eligibility criteria: Inclusion Criteria:

* Sign written consent
* Age: 20-70 y
* BMI: 18.5 - 32 kg/m2
* Healthy men and women (with no known diseases)

Exclusion criteria

* Current or previously cardiovascular disease, high blood pressure
* Diabetes Mellitus or other severe chronic disease, including severe allergies
* Use of dietary supplements and blood donations prior to, and during the study
* Known or suspected abuse of alcohol, drugs or medication
* Pregnant or are planning pregnancy during the study period
* Extreme physical activity level (more than 10 hours tough physical activity pr. week)
* Participation in other research studies
* Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff

Primary outcomes:
measure: Total cholesterol
timeFrame: 5 weeks
measure: LDL cholesterol
timeFrame: 5 weeks
measure: HDL cholesterol
timeFrame: 5 weeks
measure: Triglycerides
timeFrame: 5 weeks
Secondary outcomes:
measure: Insulin
timeFrame: 5 weeks
measure: Glucose
timeFrame: 5 weeks
measure: hs-CRP
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Tine Tholstrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engel S, Tholstrup T. Butter increased total and LDL cholesterol compared with olive oil but resulted in higher HDL cholesterol compared with a habitual diet. Am J Clin Nutr. 2015 Aug;102(2):309-15. doi: 10.3945/ajcn.115.112227. Epub 2015 Jul 1.