louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01294540: Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 73
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.

Detailed description: The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

Eligibility criteria: Inclusion:

* Healthy males and females
* Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6)
* Body mass index (BMI) of 18 to 32kg/m\^2 at Screening
* Additional inclusion criteria for Cohort 6 (healthy elderly subjects)

Exclusion

* Females of child-bearing potential
* Personal or family history of neurological abnormalities
* Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in
* A family history of cardiac abnormalities
* Thyroid abnormalities

Primary outcomes:
measure: Safety and tolerability as evidenced by the number of subjects with adverse events
timeFrame: 38 days
Secondary outcomes:
measure: To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses
timeFrame: 4 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
Study officials:
affiliation: Glendale Adventist Medical Center, Glendale, California
name: Mark Yen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940040: High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation
Official title: Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Detailed description: This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Eligibility criteria: Inclusion Criteria:

1. Age 21 years and above
2. Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio \<0.7
3. Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
4. Fit to participate in exercise therapy as determined by both physician and physiotherapist
5. Has the mental capacity to follow instructions
6. Experience shortness of breath on exertion
7. Have decreased ability to carry out activities due to shortness of breath
8. Willing to participate in the exercise program

Exclusion Criteria:

1. Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
2. Pulmonary disorder other than COPD
3. Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.

Primary outcomes:
measure: 6-minute walk distance
timeFrame: 6 weeks
Secondary outcomes:
measure: COPD Assessment Test score
timeFrame: 3 weeks, 6 weeks and 1 month after completion of program
measure: Hospital Anxiety Depression Scale
timeFrame: 3 weeks, 6 weeks and 1 month after completion of program
measure: Respiratory function test
timeFrame: 3 weeks, 6 weeks and 1 month after completion of program
measure: 6-minute walk distance
timeFrame: 3 weeks and 1 month after completion of program
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yingjuan Mok, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897740: Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
Official title: A LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATION
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pulmonary Arterial Hypertension
Keywords: sildenafil
pulmonary arterial hypertension
PAH
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to provide Sildenafil therapy for subjects who completed A1481156 study and are judged by the investigator to derive clinical benefit from continued treatment with Sildenafil, prior to reimbursement and availability for subjects in the Russian Federation.


Eligibility criteria: Inclusion Criteria:

* Patients Who Completed study A1481156 and Are Judged by the Investigator to Derive Clinical Benefit from Continued Treatment with Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation.
* Child bearing age women should have appropriate contraception.
* Signed informed consent. Patients who have a wish and possibility to follow treatment regimens in terms of the study.

Exclusion Criteria:

* Pregnant and lactating women.
* Participation in other studies in the current moment or during study period except of A1481156.
* Patients with severe acute or chronic diseases psychiatric disorders or laboratory abnormalities.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Research Institute of Pediatrics and Pediatric Surgery
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00804440: Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fasting Conditions
Official title: A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Fasted Normal, Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalency
Keywords: bioequivalency
ibuprofen
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a single, one-tablet dose in fasted subjects.


Eligibility criteria: Inclusion Criteria:

* healthy men or women, 18 years of age or older
* body mass index between 19 and 30
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* history of allergy or hypersensitivity to ibuprofen
* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* use of tobacco products within 3 months prior to study dosing
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 30 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04740840: Anti Inflammatory Treatment of Hypertension
Official title: Comparison of Anti-inflammatory Effects of Amlodipine and Levamlodipine in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Keywords: Levamlodipine
Amlodipine
Serum inflammatory factors
Anti inflammatory treatment
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical College
Sponsor class: OTHER
Collaborators: name: First Hospitals affiliated to the China PLA General Hospital
First posted: 2021-02-05
Enrollment: 200
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: To investigate the anti-inflammatory effect of amlodipine and levamlodipine in the treatment of hypertension

Detailed description: A total of 200 inpatients or outpatients in the Department of cardiovascular medicine of the third people's Hospital of Mianyang City from April 2021 to October 2021, who met the diagnostic criteria of ish2020 international hypertension practice guidelines, were selected and randomly divided into control group and experimental group, with 100 cases in each group. The control group was treated with amlodipine and the experimental group was treated with levoamlodipine. The changes of blood pressure and serum inflammatory factors were observed before and after treatment.

Eligibility criteria: Inclusion Criteria:

* ① In line with the diagnostic criteria of ISH2020 International Guidelines for Practice of Hypertension ② Age \>18 years old, gender is not limited, during the treatment did not take other drugs that will affect blood pressure: such as antidepressants, oral contraceptives, Chinese herbal medicine, etc.; Voluntary participation and signing of informed consent, and can complete all the visit plan.

Exclusion Criteria:

* (1) Those who do not want to take blood tests; (2) Left ventricular ejection fraction \< 50%, heart rate \<50 beats/min; ③ Acute coronary syndrome (unstable angina pectoris and myocardial infarction); ④ valvular heart disease, congenital heart disease, etc.; Other infectious diseases and malignant tumors; ⑥ Bronchial asthma; ⑦ Abnormal liver function and renal dysfunction (ALT BBB 0 80U/L, CR BBB 1 442mmol/L); Autoimmune diseases or any serious and fatal diseases; ⑨ Receiving lipid-lowering therapy and oral vitamins or antioxidants; They are mentally ill, have no self-awareness, and are unable to express themselves or cooperate with others.

Primary outcomes:
measure: After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group
timeFrame: One month after treatment
measure: the serum inflammatory factor level of L-amlodipine group was lower than that of amlodipine group
timeFrame: One month after treatment
measure: Serum ATP level can be used to evaluate the anti-inflammatory effect of hypertension drugs
timeFrame: One month after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01276340: Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence
Official title: Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Urinary stress incontinence
Urinary urge incontinence
Women
electrical stimulation
KEAT stimulator
quality of life
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 450
Sex: FEMALE
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: women with stress, urge and mixed incontinence with an indication for perineal reeducation follow in gynecology

Brief summary: The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.

Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* women
* age \> 18 years
* stress, urge or mixed incontinence with indication of perineal reeducation
* follow in gynecology

Exclusion Criteria:

* incontinence due to neurological disorders
* younger than 18 years old
* pregnancy
* patient with pace-maker
* patient with gynecological cancer
* patient who don't understand the electrical stimulation procedure

Primary outcomes:
measure: change of quality of life after electrostimulation
timeFrame: 2 months
Secondary outcomes:
measure: change of urinary handicap after electrostimulation
timeFrame: 2 months
measure: satisfaction after electrostimulation
timeFrame: 2 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Issoire
country: France
facility: CH Issoire
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: CHU de Saint-Etienne
name: Gautier CHENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05710380: MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Official title: Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostate Neoplasm
Keywords: prostate cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Doctors leading this study hope to learn about a software that researchers at the University of Chicago have developed to help analyze radiographic images (different techniques for taking images that allow doctors to visualize the body's internal structures) of the prostate. Participation in this research will last about 12 months. There is a one-time MRI and 1-2 biopsies and then the investigator would like to follow the participant's progress.


Eligibility criteria: Inclusion Criteria:

* Patients with known or suspected prostate cancer who have been referred for a diagnostic magnetic resonance imaging (MRI) exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
* Voluntary written informed consent before the MRI examination.

Exclusion Criteria:

* Subjects incapable of giving informed written consent.
* Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
* Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
* Prisoners.
* Minor children (under the age of 18 years old).
* Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for prostate cancer.

Primary outcomes:
measure: Decision Map Tool Compared to Oncologists
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Medicine Comprehensive Cancer Center
name: Aytekin Oto, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01428180: Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants
Official title: Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity of Fetus
Patent Ductus Arteriosus
Keywords: preterm neonates
hemodynamically relevant patent ductus arteriosus
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 35
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm neonates with patent ductus arteriosus treated in our hospital

Brief summary: The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

Detailed description: In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to

* cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
* renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD

as measured by near infrared spectroscopy

and to

* stroke volume
* cardiac output

as measured by electrical cardiometry.

The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.

Eligibility criteria: Inclusion Criteria:

* Newborn infant below 34 weeks postmenstrual age at the time of birth
* Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
* parental informed consent

Exclusion Criteria:

* Patent ductus arteriosus as part of malformation syndrome
* Additional major cardiovascular malformations

Primary outcomes:
measure: Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
timeFrame: from 10 minutes before start of infusion until 4 hours after end of transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Medical Center
state: Baden-Württemberg
Study officials:
affiliation: University of Ulm
name: Manuel B Schmid, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001580: Tissue Acquisition for Molecular Diagnostics
Official title: Tissue Acquisition for Molecular Diagnostics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm
Keywords: Molecular Diagnostics
Ovary
Tissue Acquisition
cDNA Library
CGAP
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded without patient identifiers, pathology reports, or other labels. Tissue pathology will be verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic Initiative indications.

Detailed description: Acquisition of fresh tumor and normal tissue samples is necessary for the preparation of cDNA libraries, microarray chips, tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of patient samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded without patient identifiers, pathology reports, or other labels. Tissue pathology will be verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic Initiative indications.

Eligibility criteria: INCLUSION CRITERIA:

All patients willing to sign the informed consent for whom tissue, blood or body fluids will be available are eligible.

Histopathologic diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute and is not a criteria for inclusion.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Emmert-Buck MR, Bonner RF, Smith PD, Chuaqui RF, Zhuang Z, Goldstein SR, Weiss RA, Liotta LA. Laser capture microdissection. Science. 1996 Nov 8;274(5289):998-1001. doi: 10.1126/science.274.5289.998.
citation: Krizman DB, Chuaqui RF, Meltzer PS, Trent JM, Duray PH, Linehan WM, Liotta LA, Emmert-Buck MR. Construction of a representative cDNA library from prostatic intraepithelial neoplasia. Cancer Res. 1996 Dec 1;56(23):5380-3.
citation: Emmert-Buck MR, Vocke CD, Pozzatti RO, Duray PH, Jennings SB, Florence CD, Zhuang Z, Bostwick DG, Liotta LA, Linehan WM. Allelic loss on chromosome 8p12-21 in microdissected prostatic intraepithelial neoplasia. Cancer Res. 1995 Jul 15;55(14):2959-62.