louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00729976: Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Official title: Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fever
Keywords: Ibuprofen
Suppository
febrile children
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom.

Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.


Eligibility criteria: Inclusion Criteria:

Age: 3 mo- 4 years

* Weight 6 - 18 kg
* Rectal temperature \> 38.50

Exclusion Criteria:

* Treatment with acetaminophen in the last 4 hours
* Treatment with Ibuprofen in the last 6 hours
* Unable to take oral or rectal medications
* Hypersensitivity to ibuprofen
* Renal failure
* Liver disease
* Rectal temperature can't be measured (due to anatomical or medical problem)
* Informed consent could not be granted

Primary outcomes:
measure: Maximal change in temperature during the 4-hour period after enrollment.
timeFrame: 4 hours
Secondary outcomes:
measure: Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours.
timeFrame: 4 h
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT00367276: Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.
Official title: A Multicentre, Open, Uncontrolled Study to Assess Quality of Life During Six Cycles (24 Weeks) of Treatment With an Oral Contraceptive Containing 30 µg of Ethinylestradiol and 3 mg of Drospirenone (Yasmin).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Females requiring contraceptives
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: 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 effects on the quality of life and BMI of new contraceptives.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Female requiring contraceptives.
* Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
* Regular menstrual cycle (defined as duration of 28 +/- 5 days).

Exclusion Criteria:

* No Contraindication for OC use

Primary outcomes:
measure: Change of Psychological General Well Being Questionnaire score
timeFrame: pretreatment cycle to cycle 6
Secondary outcomes:
measure: Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
timeFrame: pretreatment to cycle 6
measure: Subject satisfaction with treatment at final visit
timeFrame: at final visit
measure: Subject evaluation of changes in greasy skin and greasy hair
timeFrame: baseline to cycle 6
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00226876: Dreaming During Anaesthesia and Anaesthetic Depth
Official title: Dreaming During Anaesthesia and Anaesthetic Depth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaesthesia
Keywords: dreaming
anaesthesia
electroencephalography
bispectral index
awareness
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: Australian and New Zealand College of Anaesthetists
First posted: 2005-09-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting for elective non-cardiac surgery

Brief summary: Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor).

Detailed description: In this study, we will record the depth of anaesthesia during surgery with the BIS monitor and then interview patients immediately upon emergence to determine whether they recall dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* American Society of Anesthesiologists physical status 1-3
* Non-cardiac surgery under relaxant general anaesthesia
* Tracheal extubation planned at end of surgery

Exclusion Criteria:

* Inadequate English language skills (due to language barrier, cognitive deficit or intellectual disability)
* Major drug abuse or psychiatric condition
* Expected to be unable to co-operate or be available for followup

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: King Edward Memorial Hospital for Women
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: Melbourne Health
name: Kate Leslie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968876: Is a Smartphone Application Effective as an Oral Medication Adherence Aid
Official title: Is a Smartphone Application Effective as an Oral Medication Adherence Aid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Hypertension
Diabetes
Dyslipidemia
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will act as a pilot study that will be conducted to determine the effectiveness of a smartphone medication adherence application on adherence to oral hypertensive, diabetic, and dyslipidemic medications using a prospective randomized design. Subjects will be recruited from the University of Arkansas for Medical Sciences (UAMS) Internal Medicine Clinic North, and the study data will be collected using only subject self-reports and subject pharmacy records.


Eligibility criteria: Inclusion Criteria:

* Males and females at least 18 years of age
* Provide informed consent
* Prescribed an oral medication indicated for hypertension, diabetes, or dyslipidemia during 12 weeks pre-enrollment
* Own a smartphone (Android or iOS) with unlimited text messaging, email access, and app store access
* Oral confirmation that the subject has not previously used a medication adherence app
* Able to consult with a pharmacy or medical student during the recruitment process for purposes of consent, data collection, and/or medication reconciliation, and/or MyMedSchedule registration

Exclusion Criteria:

* Severely impaired vision
* Reside in a nursing home
* Non-ambulatory/bedridden
* Not fluent in English

Primary outcomes:
measure: Change from baseline in number of pills taken over number of pills prescribed at 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Change from baseline in number of pills taken over number of pills prescribed at 12 weeks
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Internal Medicine Clinic North; University of Arkansas for Medical Sciences
state: Arkansas
city: Little Rock
country: United States
facility: Remedy Drug
state: Arkansas
city: Little Rock
country: United States
facility: Internal Medicine Clinic West; University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Paul H Anderson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02262676: Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain
Official title: Observational and Cross-sectional Study to Assess the Sociodemographic and Clinical Characteristics of Patients Treated With RIVAROXABAN in the Context of Routine Clinical Practice of Spanish Haematologists, Cardiologists and Internists (HEROIC Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Stroke prevention on Atrial Fibrillation
Prevention and Control
Stroke
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2014-10-13
Enrollment: 2251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking rivaroxaban for stroke prevention in atrial fibrillation attending consults of hematology, cardiology and internal medicine

Brief summary: Depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Patients with atrial fibrillation
* Patients in treatment with rivaroxaban for stroke prevention in atrial fibrillation at least 3 months previous to inclusion period in study

Exclusion Criteria:

* Patients in treatment after start of study
* Patients treated with other anticoagulant treatment

Primary outcomes:
measure: Demographic Data
timeFrame: At recruitment visit
measure: Medical History
timeFrame: At recruitment visit
Secondary outcomes:
measure: Assess regional differences among the different Spanish autonomous communities on the management of patients with rivaroxaban treatment during the routine clinical practice
timeFrame: At recruitment visit
measure: Adherence to rivaroxaban treatment
timeFrame: At recruitment visit
measure: Assess the satisfaction of rivaroxaban treatment
timeFrame: At recruitment visit
measure: Assess the quality of life in patients
timeFrame: At recruitment visit
Other outcomes:
Locations:
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05270876: Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
Official title: A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interrupted time series
Primary purpose: OTHER

Brief summary: This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.


Eligibility criteria: Inclusion Criteria:

* Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
* At least three months of experience with the cochlear implant.
* Older than 18 years when entering the study.
* Subject is fluent speaker in the language used for assessments.
* Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Primary outcomes:
measure: Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet
timeFrame: 0 to 4 weeks after fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: HEARnet Clinical Studies - The University of Melbourne
state: Victoria
city: East Melbourne
country: Australia
facility: Cochlear Ltd. Melbourne
state: Victoria
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
state: België
city: Wilrijk
country: Belgium
facility: Sint-Augustinus Antwerpen
state: België
city: Mechelen
country: Belgium
facility: Cochlear Technology Centre Belgium
Study officials:
References:
Clinical trial NCT05113576: Combining Intratumoral Metabolic Heterogeneity and Dissemination Feature (Dmax) on 18F-FDG PET/CT Improves Prognosis Prediction in DLBCL
Official title: Combining Intratumoral Metabolic Heterogeneity and Dissemination Feature (Dmax) on 18F-FDG PET/CT Improves Prognosis Prediction in Diffuse Large B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Keywords: diffuse large B-cell lymphoma
Positron emission tomography (PET)
metabolic heterogeneity
dissemination
metabolic tumor volume
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 132 patients with DLBCL

Brief summary: This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-\[18F\]fluoro-D-glucose positron emission tomography/computed tomography (\[18F\]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)

Detailed description: This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-\[18F\]fluoro-D-glucose positron emission tomography/computed tomography (\[18F\]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)

Patients would be retrospectively includedin this study.The inclusion criteria included (1) pathologically proven DLBCL; (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin); (3) at least 2 evaluable hypermetabolic lesions on PET/CT;(4) underwent pre-treatment \[18F\]FDG PET/CT.

Eligibility criteria: Inclusion Criteria:

* (1) pathologically proven DLBCL, (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin),(3) at least 2 evaluable hypermetabolic lesions on PET/CT, (4) underwent pre-treatment \[18F\]FDG PET/CT

Exclusion Criteria:

* (1) patients who had received surgical resection or other treatments before chemotherapy, (2) patients who had coexistent central system lymphoma or other types of malignancies

Primary outcomes:
measure: the accuracy of prognosis prediction
timeFrame: Through study completion, about 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT04787276: Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
Official title: Probiotic E.Coli Nissle 1917 Comparing to Lactulose and Rifaximin in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Liver Cirrhosis
End Stage Liver DIsease
Keywords: hepatic encephalopathy
Liver Cirrhosis
End Stage Liver DIsease
E.coli Nissle 1917
Probiotic
lactulose
rifaximin
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 42
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: The purpose of study to assess the short-term efficacy and safety of probiotic E.coli Nissle 1917 strain comparing to lactulose and rifaximin in patients with mild (Stage 1-2) or minimal hepatic encephalopathy


Eligibility criteria: Inclusion Criteria:

* Cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement or radiological study;
* presence of minimal or mild (Grade 1-2) HE as defined by West Haven criteria;
* two or more documented episodes of HE in the last 6 months, in addition to at least one episode in the last 3 months;
* subject is capable and willing to comply with all study procedures;
* signed inform consent.

Exclusion Criteria:

* history of taking L-ornithine- L -aspartate, zinc, metronidazole, or neomycin, antibiotics, probiotics and yogurt consumption within 6 weeks;
* subject has a history of allergy or intolerance to lactulose and/or rifaximin;
* alcohol intake during the past 6 month or during follow up;
* recent (6 weeks) gastro-intestinal bleed;
* hepato-cellular carcinoma or liver transplantation;
* renal insufficiency;
* significant comorbid illness such as heart or respiratory failure;
* concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection;
* any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies;
* subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments.

Primary outcomes:
measure: Change in Stroop test
timeFrame: 1 month
measure: Change in serum ammonia
timeFrame: 1 month
Secondary outcomes:
measure: Change in serum inflammatory cytokine
timeFrame: 1 month
measure: Bacteriology measured in the stool flora by specialized non-culture techniques
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Bogomolets National Medical University
name: Elina Manzhalii, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05125276: Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Official title: Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Non ST Segment Elevation Acute Coronary Syndrome
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 3090
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: Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.

Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.

Study design: Open-label, multicentre randomized controlled trial.

Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.

Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.

Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
* Successful PCI (according to the treating physician)

Exclusion Criteria:

* Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
* Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
* Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
* Planned surgical intervention within 12 months of PCI
* Pregnant or breastfeeding women at time of enrolment
* Participation in another trial with an investigational drug or device

Primary outcomes:
measure: Bleeding endpoint
timeFrame: 12 months
measure: Ischemic endpoint
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
Study officials:
References: