louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01718652: A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers
Official title: An Open-Label, Single Sequence Study to Assess the Effect of a Single Dose of Cyclosporine on the Steady-State Pharmacokinetics of JNJ-28431754 (Canagliflozin) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Canagliflozin (JNJ-28431754)
Pharmacokinetics
Cyclosporine
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how a single dose of cyclosporin affects the pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

Detailed description: This study will be an open label (all volunteers and study staff know the identity of assigned treatments), single-center, multiple-dose study to determine how cyclosporin (a drug which reduces the activity of a patient's immune system) affects the pharmacokinetics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. Each volunteer will participate in the study for approximately 47 days.

Eligibility criteria: Inclusion Criteria:

* Must have body mass index between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* If a woman, must be either postmenopausal, defined as no spontaneous menses for at least 18 months or amenorrhea for at least 6 months or surgically sterile (have had a hysterectomy, or tubal ligation)

Exclusion Criteria:

* History of smoking or use of nicotine-containing substances within the previous 2 months
* Have had history of or current medical illness considered to be clinically significant by the Investigator

Primary outcomes:
measure: Plasma concentrations of canagliflozin (JNJ-28431754)
timeFrame: Day 7 and Day 8
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: Up to 47 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development,L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002352: A Study of Lobucavir in Patients With AIDS
Official title: Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infections
HIV Infections
Keywords: Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.

Detailed description: Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.
* TMP / SMX.
* Isoniazid.
* Dapsone.
* Fluconazole.
* Ketoconazole.
* Rifabutin.
* Fluoxetine HCl.
* Acetaminophen.
* Antacids.
* Metamucil.
* Multivitamins.
* Other drugs with approval from sponsor.

Patients must have:

* AIDS.
* CD4 count \< 200 cells/mm3.
* Cytomegalovirus ( CMV ) viruria and virosemenia.
* No evidence of intraocular CMV.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness.
* Inability to take oral medication.
* Allergy to nucleoside analogs.
* Diarrheal illness.
* Poor venous access.
* Positive test for drugs of abuse.
* Any other condition that would render patient unsuitable for study.

Patients with the following prior conditions are excluded:

* History of pancreatitis.
* Recent diarrheal illness.
* History of weight loss.
* Acute serious illness within 4 weeks prior to study entry.

Prior Medication:

Excluded within 4 weeks prior to study entry:

* Erythropoietin.
* Any agent with anti-CMV activity.
* Other investigational agents.

Prior Treatment:

Excluded within 4 weeks prior to study entry:

* Surgery.
* Blood transfusion. Drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Mount Zion Med Ctr / UCSF
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Adm Med Cntr
state: California
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT02605252: New Strategy Study of Functional Cure of Chronic Hepatitis B
Official title: A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B, Chronic
Keywords: Chronic hepatitis B
Peginterferon alfa-2b
Nucleotide analogue
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha-2b and NAs.

Detailed description: CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.

Eligibility criteria: Inclusion Criteria:

1. CHB patients who had received NAs for more than 12 months.
2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
3. Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL.
4. Hepatitis B virus DNA not detectable.

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
2. Patients with other factors causing liver diseases.
3. Pregnant and lactating women.
4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
5. Patients with diabetes, autoimmune diseases.
6. Patients with important organ dysfunctions.
7. Patients with serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. )
8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
9. Patients who can't come back to clinic for follow-up on schedule.

Primary outcomes:
measure: HBsAg loss
timeFrame: Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The third affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Xiang Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05103852: Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.
Official title: Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac MRI
Right Cardiac Catheterization
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Having an indication for a diagnostic of right cardiac catheterization at the J Cartier Hospital for one of the following pathologies: dilated, restrictive cardiomyopathy, pulmonary arterial hypertension, chronic constrictive pericarditis, chronic post-embolic pulmonary heart.
* Subject affiliated or beneficiary of a social security scheme
* Patient having freely signed the informed consent.

Exclusion Criteria:

* Pregnancy (declarative, known pregnancy, any unexplained period delay in a woman of childbearing age)
* Presence of a contraindication to MRI: intraocular metallic splinter, surgical clip for cerebral aneurysm, claustrophobia, defibrillator, implanted electronic equipment) or to gadolinium chelates (anaphylactic reactions to gadolinium chelates, creatinine clearance \<= 30 ml / min).
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
* Patient participating in another clinical study

Primary outcomes:
measure: Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Massy
country: France
facility: Hôpital Jacques Cartier
Study officials:
References:
Clinical trial NCT03381352: Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
Official title: Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anal Cancer
Keywords: Radiotherapy
Anal cancer
IMRT
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-12-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.


Eligibility criteria: Inclusion Criteria:

* CT/MRI diagnosed stage cT1-4N0-3;
* Histologically confirmed anal squamous carcinoma;
* KPS \>= 70
* Adequate organ function;
* No previous radiotherapy or chemotherapy;
* No surgery.

Exclusion Criteria:

* Previous malignant cancer history;
* Allegic to 5-fu or MMC

Primary outcomes:
measure: Response rate
timeFrame: 8 weeks after IMRT
Secondary outcomes:
measure: Adverse events
timeFrame: from start of IMRT to 8 weeks after IMRT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese academy of medical sciences
state: Beijing
Study officials:
References:
Clinical trial NCT03608852: Unconventional Financial Incentives for Smoking Cessation
Official title: Bad is Stronger Than Good: Unconventional Financial Incentives for Smoking Cessation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking Cessation
Lead sponsor: Miami VA Healthcare System
Sponsor class: FED
First posted: 2018-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The goal of this study is to enroll 36 active smokers

Brief summary: The proposed study is a randomized study of actively smoking veterans cared for at the Miami VA Medical Center. Subjects are randomized into 2 groups and will all receive a regimen of nicotine replacement therapy (NRT) standardized to their smoking habit. Subjects are followed biweekly for smoking cessation by using biochemical tests (exCO and COHb) to determine smoking abstinence. The first group called the Banked-Money Group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. The second group called the Reward Group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking.


Eligibility criteria: Inclusion Criteria:

Enrollment criteria include subjects 18 years of age or older, currently smoking at least a half a pack of cigarettes a day, who have at least a ten-pack year smoking history, are interested in quitting smoking, agree to submit to exhaled breath and ABG analysis and have reliable means of visiting the clinic every two weeks. Subjects must be able to tolerate NRT including patches and lozenges and meet with the VA smoking cessation counselor.

Exclusion Criteria:

Subjects will not be enrolled if they are currently taking varenicline as the VA disallows concurrent use of varenicline and NRT.

Primary outcomes:
measure: Smoking cessation rate
timeFrame: 1 year
Secondary outcomes:
measure: Household income
timeFrame: 1 year
measure: Smoking habits
timeFrame: 1 year
measure: Nicotine dependence
timeFrame: 1 year
measure: Nicotine withdrawal symptoms
timeFrame: 1 year
measure: Anxiety / Depression
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03971552: Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed
Official title: Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Mechanical thrombectomy
Magnetic resonance angiography
Angiogram
Angiography
Magnetic resonance imaging
Revascularization
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-03
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke (AIS) patients who underwent magnetic resonance imaging (MRI) based screening for acute neurovascular evaluation and who underwent mechanical thrombectomy (MT) at one comprehensive stroke center.

Brief summary: The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics.

Consecutive patients (912) treated by mechanical thrombectomy (MT) at a large comprehensive stroke center between January 2012 and December 2017 who were screened using pre-intervention MRI were included. Patient's characteristics and procedural data were collected. Analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial MRA.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke

Exclusion Criteria:

Primary outcomes:
measure: time from groin puncture to clot contact
timeFrame: 1 day
Secondary outcomes:
measure: modified Rankin Score
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01445652: A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Official title: A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
First posted: 2011-10-04
Enrollment: 113
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.


Eligibility criteria: Inclusion Criteria:

* Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.
* Willing and able to follow the protocol.
* Currently wearing spectacles full-time (at least five days per week, eight hours per day).
* Has never worn contact lenses (more than one day) before.
* Agrees to not participate in other clinical research for the duration of this study.
* Can attain at least 6/9 in each eye with the study optical correction.
* Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group).
* Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day.
* Owns or has regular access to a mobile phone and is familiar with SMS text messaging.
* Has an up-to-date and functional pair of spectacles at time of enrollment.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has an ocular or systemic disorder that would normally contraindicate contact lens wear.
* Is using any topical medication such as eye drops or ointment.
* Has had corneal refractive surgery.
* Has had cataract surgery.
* Has diabetes.
* Has taken part in other clinical research within two weeks of starting the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Subjective Happiness With Correction Type
timeFrame: Month 6
measure: Subjective Vision With Correction Type
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: University of Manchester
name: Philip Morgan, PhD MCOptom FAAO FBCLA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05874752: Myocardial Function Assessment in Patients With Coronary Artery Disease Using Noninvasive Myocardial Work
Official title: Myocardial Function Assessment in Patients With Coronary Artery Disease Using Noninvasive Myocardial Work
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Noninvasive Myocardial Work
Coronary Artery Disease
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were hospitalized for coronary angiography with angina or equivalent symptoms.

Brief summary: Noninvasive pressure-strain loop (PSL) derived myocardial work (MW) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. The aim of this study was to assess left ventricular (LV) myocardial function in symptomatic patients with coronary artery disease using the promising method.

Methods: Transthoracic echocardiography was performed on patients with angina or equivalent symptoms before coronary angiography. Images were stored and imported into the software for further offline analysis of PSL-based MW. MW analysis were carried out on each patient for global and regional myocardial function assessment.


Eligibility criteria: Inclusion Criteria: Patients who were hospitalized for coronary angiography with angina or equivalent symptoms.

-

Exclusion Criteria: Acute coronary syndrome, left main stem coronary disease, left ventricular ejection fraction (LVEF) below 55%, observed resting regional wall motion abnormalities (RWMAs), non-sinus rhythm, intraventricular block, previous cardiac surgery, severe valvular heart disease, hypertrophic cardiomyopathy, myocarditis, pericardial diseases, pulmonary hypertension, and poor image quality.

-

Primary outcomes:
measure: myocardial function
timeFrame: baseline (before coronary angiography)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yingmei Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426152: Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome
Official title: Association Between Progesterone Levels on the Day of Ovulation Induction and IVF Outcome: Retrospective Study With 2500 Controlled Ovarian Stimulations Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Infertility
Keywords: IVF
progesterone
ovulation induction
pregnancy rates
Female Infertility Due to Nonimplantation
Lead sponsor: Bollmann Bruckner Noss
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 2555
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with infertility undergoing assisted reproduction techniques, i.e. in vitro fertilization.

Brief summary: Progesterone levels measured in blood/serum of patients on the day of ovulation induction following controlled ovarian stimulation for in vitro fertilization may be associated with pregnancy outcome. The hypothesis is that higher progesterone levels are associated with lower implantation rates due to changes in the endometrial receptivity.


Eligibility criteria: Inclusion Criteria:

* IVF/ICSI following controlled ovarian stimulation
* progesterone measured on the day of ovulation induction
* informed consent

Exclusion Criteria:

* missing consent

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 13 weeks
Secondary outcomes:
measure: Delivery after 23.gestational weeks
timeFrame: 9 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Praxis Bollmann-Brückner-Noss
state: Bavaria
Study officials:
affiliation: Center for Reproductive Medicine
name: Robert Ochsenkuehn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ochsenkuhn R, Arzberger A, von Schonfeldt V, Gallwas J, Rogenhofer N, Crispin A, Thaler CJ, Noss U. Subtle progesterone rise on the day of human chorionic gonadotropin administration is associated with lower live birth rates in women undergoing assisted reproductive technology: a retrospective study with 2,555 fresh embryo transfers. Fertil Steril. 2012 Aug;98(2):347-54. doi: 10.1016/j.fertnstert.2012.04.041. Epub 2012 May 24.