louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01171547: Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
Official title: Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bacteremia
Keywords: pharmacokinetics
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.


Eligibility criteria: Inclusion Criteria:

* male or female of 18 years or older
* females: negative pregnancy test
* Hospitalisation in the medical ICU
* High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
* Subjects receiving standard antibiotic treatment for Gram-positive infection
* Evidence of renal failure
* Clinical necessity for continuous renal replacement therapy
* Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.

Exclusion Criteria:

* Skeletal muscle disorders or CPK levels of \> 2 x ULN
* History of hypersensitivity to the drug
* Participation in another study
* Subjects with a history of muscle disease
* Patients with severe liver function impairment (Child C)
* Life expectancy of less than 5 days

Primary outcomes:
measure: Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
timeFrame: PK on days 1, 3, and 5
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Medical Intensive Care Unit, University Hospital Zurich
Study officials:
References:
Clinical trial NCT06972147: Prevalence and Description of FIRE (Food Induced Immediate Response of the Esophagus) in the Pediatric Population With Eosinophilic Esophagitis
Official title: Prevalence and Description of FIRE (Food Induced Immediate Response of the Esophagus) in the Pediatric Population With Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eosinophilic Esophagitis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2025-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient follow-up in the allergology unit of Angers University Hospital

Brief summary: A new clinical entity of eosinophilic esophagitis, Food Induced Immediate Response of the Esophagus or FIRE, has been described since 2020. Diagnostic criteria are not clearly established. Specific questioning is necessary for differential diagnosis, such as the oro-pharyngeal syndrome notably described in pollinics, or a mechanical blockage strictly speaking linked to esophagitis. The aim is to obtain epidemiological data on this entity.


Eligibility criteria: Inclusion Criteria:

* Patients over 6 and under 18 years of age at the time of inclusion
* Follow-up in the allergology unit of Angers University Hospital for eosinophilic esophagitis

Exclusion Criteria:

* Patients or legal representative with severe communication or language comprehension difficulties
* Patients or legal representatives objecting to study participation

Primary outcomes:
measure: diagnosis of FIRE syndrome
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Angers
name: Anne HOPPE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736047: Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Official title: A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smokers
Keywords: Smokers
smoking cessation
vaccine
antibodies
anti-nicotine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female smoking subjects age 18 to 65 years of age
* Subjects must be smoking 10 or more cigarettes per day during the past 12 months
* The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
* The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion Criteria:

* Attempted to quit smoking in the three (3) months.
* Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Smoking status
timeFrame: 12 weeks
measure: Exhaled carbon monoxide
timeFrame: 12 weeks
Secondary outcomes:
measure: Smoking status at various time intervals from target quit date to the end of the study
timeFrame: 52 weeks
measure: Safety and tolerability
timeFrame: 52 weeks
measure: Immunogenicity (specific anti-nicotine antibodies in serum)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041847: Gene-Environment Interaction in Prostate Cancer
Official title: Gene-Environment Interaction in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: gene
environment
occupation
diet
interaction
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-22
Enrollment: 881
Sex: MALE
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine whether certain environmental factors, namely occupational exposures and diet, have a greater effect on prostate cancer risk in the presence of selected inherited genetic factors.


Eligibility criteria: men diagnosed with prostate cancer before age 70 and race/age frequency matched healthy controls

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT00884247: Structured Treatment of Gastroesophageal Reflux in a Company Health Care Setting, -Effect on Quality of Life, Symptoms and Productivity
Official title: A Prospective, Non Interventional Study to Evaluate the Effects on Quality of Life, Symptoms and Productivity in Patients With Gastroesophageal Reflux Disease (GERD) After 6 Weeks Structured Treatment in a Company Health Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Keywords: GERD
Quality of life
Structured treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Company health care setting

Brief summary: The study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients.


Eligibility criteria: Inclusion Criteria:

* Female and/or male aged \> 18 years
* Diagnosis of GERD confirmed
* Prescription of GERD treatment or already receiving GERD treatment

Exclusion Criteria:

* Any symptom suggesting a need for further investigation
* Previous participation in the present study
* Current participation in a clinical study or participation in a clinical study during the last 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hälsocenter
country: Sweden
facility: Research Site
state: Södertälje
Study officials:
affiliation: AstraZeneca Sweden
name: Svante Sjöstedt, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Sweden
name: Dan Regberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04113447: Mitochondrial Donation: An 18 Month Outcome Study.
Official title: Mitochondrial Donation: An 18 Month Outcome Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitochondrial Diseases
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2019-10-02
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with mitochondrial disease undergoing mitochondrial donation treatment

Brief summary: The Investigator proposes to record the fetal and postnatal development of children conceived using Mitochondrial Donation (MD) and to perform expert assessment of development at 18 months (corrected for gestational age) using the internationally validated Bayley-III developmental assessment tool.

Detailed description: To record the fetal and postnatal development of children conceived using Mitochondrial Donation and to perform internationally validated Bayley-III developmental assessment tool at 18 months (corrected for gestational age).

The null hypothesis for this research is that children born following the use of Mitochondrial Donation (IVF) techniques have normal neurodevelopment developmental outcomes at 18 months.

Eligibility criteria: Inclusion Criteria:

Women will only be eligible if they meet all of the following criteria.

* Women with confirmed mtDNA mutation
* Suitable to undergo Mitochondrial Donation as a treatment (in line with HFEA license)
* Informed Consent for the study obtained before Mitochondrial Donation treatment commences
* Ability and willingness to adhere to the protocol including evaluation schedule
* Willingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)

Exclusion Criteria:

Women will not be eligible if they meet any of the following criteria

* Declined Mitochondrial Donation as a treatment (in line with HFEA license)
* Inability or unwillingness to adhere to the protocol including evaluation schedule
* Unwillingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)

Primary outcomes:
measure: A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected
timeFrame: 18 months
Secondary outcomes:
measure: 1)Normal hearing as assessed by formal audiology,
timeFrame: 18 months
measure: 2)Normal vision as assessed by ophthalmologist
timeFrame: 18 months
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne & Wear
Study officials:
References:
Clinical trial NCT03129347: Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers
Official title: Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2017-04-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Detailed description: This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.

Eligibility criteria: Inclusion Criteria:

* Males and females 18 to 55 years of age
* Provide written informed consent
* Body Mass index (BMI) ranging from 18 to 32 kg/m2
* Adequate venous access
* No clinically significant concurrent medical conditions
* Males subjects must agree to use an acceptable method of birth of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration
* Female subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

* Please contact the site for more information

Primary outcomes:
measure: Pharmacokinetic parameters of nalmefene
timeFrame: 17 days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 17 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
Study officials:
affiliation: Vince & Associates Clinical Research, Inc.
name: Debra Kelsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788047: A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
Official title: A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Huntington Disease
Alzheimer Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2008-11-10
Enrollment: 14
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 drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects.
* Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.

Exclusion Criteria:

* Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
* Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.

Primary outcomes:
measure: Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
timeFrame: Day 12
Secondary outcomes:
measure: Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
timeFrame: Day 15
measure: Dextrorphan (the metabolite of dextromethorphan) exposure
timeFrame: Day 12
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01480947: The Treatment Effect of Bio-Three on Children With Enteritis
Official title: The Treatment Effect of Bio-Three on Children With Enteritis Due to Salmonella or Rotavirus or Any Unknown Reason
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroenteritis
Diarrhea
Keywords: probiotics
pediatric
salmonella
rotavirus
gastroenteritis
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2011-11-29
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are infected by rotavirus or salmonella.

Base on the past researches, there is benefit effect of probiotics on patients with diarrhea or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three independent probiotics, will be used in patients with acute diarrhea.

This is a single site, controlled clinical research. About 80 patients will be enrolled into this study to evaluate the benefit effect of bio-Three among patients with acute enteritis due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

Detailed description: Intervention: Subjects were randomly assigned to receive control treatment (intravenous fluid, oral rice and half strength milk formula) or add-on treatment of the probiotics (Bio-three®) to the control treatment.

Main outcome measures: Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Exclusion criteria included immunodeficiency, severe abdominal distension with risk of bowel perforation, severe infection or sepsis, history of gastrointestinal tract surgery, and probiotics use in the preceding 1 week.

Eligibility criteria: Inclusion Criteria:

* Clinical symptom of diarrhea less than 3 days

Exclusion Criteria:

* Severe abdominal distension with risk of bowel perforation
* Risk for sepsis
* Past history with surgical operation of gastrointestinal tracts
* immunodeficiency
* probiotics use in the preceding 1 week

Primary outcomes:
measure: Quantitative Vesikari scales and qualitative severe diarrhea
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Pediatrics, Kaohsiung Veterans General Hospital
Study officials:
affiliation: Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
name: Yung-Feng Huang, MD. MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00984347: Breast Stimulation Versus Pitocin for Induction of Labor
Official title: Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Induction
Keywords: nipple stimulation
Oxytocin
induction of labor
term pregnancies
grandmultipara
VBAC
PROM
comparison of two methods for induction of labor
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* completed 37 weeks gestation
* singleton pregnancy
* reassuring fetal heart rate at admission monitor

Exclusion Criteria:

* multiple pregnancies
* known fetal malformations
* non reassuring NST
* polyhydramnios (AFI\>220)
* oligohydramnios
* PET
* IUGR
* macrosomia (EFW \>4000g)
* antepartum bleeding
* maternal fever

Primary outcomes:
measure: time from induction to delivery
timeFrame: 24h
Secondary outcomes:
measure: fetal distress (monitor assessment, cord ph)
timeFrame: 24 h
measure: cesarean section rate
timeFrame: 24h
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Mt. Scopus
Study officials:
affiliation: Hadasah Medical Organization
name: Drorith Hochner-Celnikeir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04951947: JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer
Official title: A Prospective, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer With Previous Chemotherapy Combined With PD-L1 Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Small-cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.


Eligibility criteria: Inclusion Criteria:

* 1. The imaging diagnosis is the extensive stage of SCLC
* 2. The patient failed first-line EC+PD-L1 treatment
* 3 PS 0-1

Exclusion Criteria:

* 1. Diagnosed as non-small cell lung cancer
* 2. Women during pregnancy
* 3. Patients with symptomatic brain metastases
* 4. PS≥2

Primary outcomes:
measure: ORR
timeFrame: 1 year
Secondary outcomes:
measure: PFS
timeFrame: 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: