louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00833391: Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)
Official title: An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Healthy Volunteer
Keywords: healthy volunteer
formulations
bioavailability
pharmacokinetics
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.

Detailed description: This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.

Eligibility criteria: Inclusion Criteria:

* healthy, male and female subjects aged between 18 and 65 years old.
* normal body weight.
* normal ECG, vital signs and lab tests.
* normal kidney function
* agree to use acceptable contraceptive methods required.
* capable of giving written informed consent.

Exclusion Criteria:

* positive blood alcohol or urine drug test.
* positive hepatitis B/C and HIV
* donation of more than 450 mL blood within the 56 days.
* sensitivity to gabapentin
* pregnant or lactating females
* smoker
* certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
* history of seizure

Primary outcomes:
measure: gabapentin concentrations in blood
timeFrame: measured up to 36 hr after dosing
Secondary outcomes:
measure: gabapentin concentrations in urine
timeFrame: measured up to 36 hr after dosing
measure: Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.
timeFrame: throughout the study
Other outcomes:
Locations:
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00989391: A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth
Official title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03654764 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1 multiple dose safety toleration pharmacokinetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-05
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given once or twice daily by mouth for 10 days.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Primary outcomes:
measure: safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination.
timeFrame: 10 days
Secondary outcomes:
measure: Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, AUCtau (Day 10)/AUCtau (Day 1), CL/F
timeFrame: 10 days
measure: Urine pharmacokinetics: Ae24 & Ae24% (for once daily doses) or Ae12 & Ae12% (for twice daily dose) on Day 10, CLR
timeFrame: 10 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01314391: Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor
Official title: Pilot Case-Control Study of WT1 Mutations in Wilms Tumor Patients Who Develop ESRD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Renal Failure
Keywords: stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
renal failure
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-03-14
Enrollment: 20
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of Wilms Tumor

Brief summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from patients with Wilms tumor.

Detailed description: OBJECTIVES:

* To determine whether Wilms Tumor (WT) patients without WT1-associated congenital anomalies or syndromes, but with end-stage renal disease (ESRD) unrelated to progressive bilateral tumors, carry germline WT1 mutations.
* To determine whether non-syndromic WT1 germline mutation carriers have a substantially higher incidence of ESRD than do WT patients who do not harbor WT1 mutations.

OUTLINE: Archived blood and tumor tissue specimens (or DNA isolated from these samples) are analyzed for WT1 mutations by gene sequencing and PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of Wilms Tumor (WT)
* Patients who participated in the NWTS-5 protocol

  * Non-syndromic patients who developed end-stage renal disease (ESRD) during 5-10 years for reasons other than progressive bilateral WT
  * Matched control patients who had not developed ESRD by the time (since WT onset) of ESRD diagnosis
* Blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Vicki Huff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00062491: Study of Karenitecin (BNP1350) to Treat Malignant Melanoma
Official title: Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Neoplasm
Lead sponsor: BioNumerik Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Crown Bioscience
First posted: 2003-06-12
Enrollment: 46
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: The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.


Eligibility criteria: * Confirmed diagnosis of malignant melanoma
* Measurable disease
* Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN
* No prior treatment with other camptothecin drug.
* ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C
* ECOG Performance Status 0-1
* Negative pregnancy test for female patients

Primary outcomes:
measure: Overall Response
timeFrame: start of treatment until progressive disease
Secondary outcomes:
measure: Objective Tumor Response Rate
timeFrame: Start of treatment to date of response
measure: Duration of Response
timeFrame: Date of response to date of progressive disease
measure: Overall Survival
timeFrame: Randomization to date of death from any cause
measure: Progression Free Survival
timeFrame: Randomization to disease progression
Other outcomes:
Locations:
city: Tampa
country: United States
facility: For Information call 210-614-1701 for a site near you
state: Florida
Study officials:
References:
Clinical trial NCT02186691: Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Official title: Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetralogy of Fallot With Pulmonary Stenosis
Keywords: pulmonary valve replacement
tetralogy of Fallot
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 11
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at 35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or pulmonary regurgitation (PR). It is well established that these lesions can lead to irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve replacement technique was developed to avoid long term right ventricular dysfunction. Pulmonary valve replacement indications are based upon the presence of symptoms at exercise and/or morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatation/dysfunction. The best timing of such intervention is still underdebate with the main aim of having the right balance between avoiding long term sequelae of PR or PS and being the latter possible to push ahead the need for new intervention. Recent publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging is feasible and could help the physician to best determine the right timing for PVR in this population of patients. Cardiac function assessment at rest and during exercise is possible using MR and our centre has developed a program for cardiac exercise during MRI. This could help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.


Eligibility criteria: Inclusion Criteria:

- older than 14 year-old, with repaired tetralogy of Fallot requiring pulmonary valve

Exclusion Criteria:

* liver failure, kidney failure,
* contra indication to MRI study,
* non-affiliated to the national health care program

Primary outcomes:
measure: determination of the quantity of diffuse myocardial fibrosis
timeFrame: 2.5 years
Secondary outcomes:
measure: determination of contractile reserve
timeFrame: 2.5 years
Other outcomes:
measure: determnation of variation fibrosis biomarkers
timeFrame: 2.5 years
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Beatrice BONELLO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817791: Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery
Official title: Phase 1 Study of Protective Effect of Hyperbaric Oxygen Preconditioning on Brain and Myocardium Injury During CABG Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Myocardial Injury
Keywords: CABG
hyperbaric oxygen
preconditioning
S100B
NSE
Troponin I
CABG surgery
neuroprotection
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 49
Sex: MALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Animal studies have shown that preconditioning with hyperbaric oxygen can induce central nervous system and heart ischemic tolerance. This study was designed to determine the protective effect of hyperbaric oxygen preconditioning on brain and myocardium ischemia-reperfusion injury during coronary artery bypass graft surgery.

Detailed description: 60 patients scheduled to undergo coronary revascularization were recruited for this trial. Exclusion criteria included Emergency operation, age older than 80 years, learning difficulty, previous cerebrovascular disease, visual or hearing impairment, history of pneumothorax, Claustrophobia, middle ear disease, EF \< 35%. Patients were randomized either to the control group or hyperbaric oxygen group. The laboratory analysis of markers included S100B, NSE and troponin I. The assessment of cognitive dysfunction was performed 5 days before surgery and 7 days after surgery and haemodynamic measurements, length of stay in ICU, length of stay in hospital post-operation were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo coronary revascularization surgery.

Exclusion Criteria:

* Emergency operation
* Age older than 80 years
* Learning difficulty
* Previous cerebrovascular disease
* Visual or hearing impairment
* History of pneumothorax, claustrophobia, middle ear disease, EF \< 35%

Primary outcomes:
measure: Post operative cognitive dysfunction
timeFrame: 5 days before surgery and 7 days after surgery
Secondary outcomes:
measure: S100B protein,NSE and Troponin I
timeFrame: Within the first 3 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of anaesthiology,Xijing hospital
name: xiong L Z, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02925091: Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason \>10 years ago

Brief summary: Helicobacter pylori infects \~ 50% of the world's population and a quarter of the European population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers and gastritis. Chronic infection with H. pylori is a risk factor for the development of stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of success for an antimicrobial eradication therapy is drastically reduced by the significant increase in antibiotic resistance in Austrian H. pylori isolates. The currently available data were obtained however from narrowly defined geographical regions and the clinical routine without information on patient selection. We suspect a considerable geographical variability of resistance patterns and a clinical bias for a preferential investigation of patients with unsuccessful, empirical eradication therapy. The objective of the proposed study is therefore an Austria-wide collection of data on H. pylori resistance in a prospective clinical study. The data thus collected will enable a significant improvement in current treatment recommendations.


Eligibility criteria: Inclusion Criteria:

* Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason \>10 years ago
* Older than 18 years of age
* Written informed consent

Exclusion Criteria:

* Previous H. pylori eradication therapies
* Antimicrobial treatment for other reasons than H. pylori eradication within 3 months prior to gastroscopy

Primary outcomes:
measure: Antimicrobial resistance of H. pylori isolate
timeFrame: 1 day (Once)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bilgilier C, Stadlmann A, Makristathis A, Thannesberger J, Kastner MT, Knoflach P, Steiner P, Schoniger-Hekele M, Hogenauer C, Blesl A, Datz C, Huber-Schonauer U, Schofl R, Wewalka F, Puspok A, Mitrovits N, Leiner J, Tilg H, Effenberger M, Moser M, Siebert F, Hinterberger I, Wurzer H, Stupnicki T, Watzinger N, Gombotz G, Hubmann R, Klimpel S, Biowski-Frotz S, Schrutka-Kolbl C, Graziadei I, Ludwiczek O, Kundi M, Hirschl AM, Steininger C; Austrian Helicobacter Study Group of the Austrian Society of Gastroenterology and Hepatology. Prospective multicentre clinical study on inter- and intrapatient genetic variability for antimicrobial resistance of Helicobacter pylori. Clin Microbiol Infect. 2018 Mar;24(3):267-272. doi: 10.1016/j.cmi.2017.06.025. Epub 2017 Jun 29.
Clinical trial NCT00890591: Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension
Official title: National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: hypertension
angiotensin II type 1 receptor blocker
olmesartan
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-04-30
Enrollment: 144
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.


Eligibility criteria: Inclusion Criteria:

* Stage 1 and 2 hypertension without treatment for at least 2 weeks
* Women with no risk of becoming pregnant

Exclusion Criteria:

* Study participation could result in risk to health of subject
* Cardiovascular disease
* Secondary hypertension or stage 3 hypertension
* Myocardial infarction within the last 6 months
* Congestive heart failure
* Pulmonary edema
* Valvular alterations or rheumatic cardiopathy
* Clinically relevant conduction disorders significant arrhythmias
* Alcohol or illicit drug use
* Medication abuse
* Pregnant or nursing women

Primary outcomes:
measure: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
timeFrame: 4 - 9 wks of olmesartan monotherapy
measure: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)
timeFrame: 4 to 9 weeks on combination therapy
measure: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
timeFrame: 4 to 9 weeks
measure: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
timeFrame: 4 - 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03153891: Nature as a Buffer Among People With Chronic Pain
Official title: Virtual Nature: Benefits for Older Adults Who Experience Chronic Pain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: environment
nature
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 23
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This randomized controlled trial examines the effect of nature exposure on pain intensity levels among older adults who experience chronic pain. Investigators examine the effects of nature on: the experience of chronic pain, on pain catastrophizing, and on attention restoration.

Detailed description: Nature has been used to reduce pain in the context of acute pain (e.g., during painful medical procedures) but nature has not been examined as an intervention strategy to address chronic pain. Second, the mechanism though which nature might reduce the experience of pain is not well understood. Participants are cognitively intact individuals aged 60-90 who experience chronic pain and who rate their health as fair, good or excellent. Participants are randomly assigned to one of three conditions: virtual reality (VR) nature; VR built environment; or control. Researchers examine effects of VR nature exposure on the experience of chronic pain, pain catastrophizing, and on attention restoration as well as the relations among these variables.

Eligibility criteria: Inclusion Criteria:

* rate health as "fair" "good" or "excellent"
* experience chronic pain
* cognitively intact
* do not use wheelchair

Exclusion Criteria:

Primary outcomes:
measure: Experience of chronic pain
timeFrame: up to 3 weeks; from date of randomization until 2nd data collection date
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: up to 3 weeks; from date of randomization until 2nd data collection date
measure: cognitive functioning
timeFrame: up to 3 weeks; from date of randomization until 2nd data collection date
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
affiliation: Design + Environmental Analysis, Cornell University
name: Nancy M Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References: