louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03530709: Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers
Official title: Traditional vs Virtually-integrated Co-management of Children With Medical Complexity Between Complex Care and Community-based Primary Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.


Eligibility criteria: Inclusion Criteria: Caregiver of patient seen for co-managed care in Special Care Clinic; caregiver has a smartphone that will accept the technology; PCPs office has wireless internet connection -

Exclusion Criteria: Child is in foster care

-

Primary outcomes:
measure: Proportion of co-managed visits scheduled that are completed through videoconferencing
timeFrame: 12 months
Secondary outcomes:
measure: Caregiver Perception of integrated care
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
measure: Caregiver Satisfaction with Telehealth
timeFrame: After every telehealth visit (up to 3 visits)
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jeanne Van Cleave
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748409: Physiopathological Study of Autonomic Failure in Parkinson's Disease
Official title: Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 47
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's disease
* ages 45 to 80 years, both genders
* patients who signed informed consent

Exclusion Criteria:

* autonomic function modifying treatment
* pre-existing neuropathy or risk factors for neuropathy
* dementia
* colonic disorders
* coagulation disorders (may be due to treatment)

Primary outcomes:
measure: Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate association between autonomic failure and severity factors in Parkinson's disease
timeFrame: 3 months
measure: Evaluate consequences of autonomic failure on quality of life and sleep quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital
state: Loire Atlantique
Study officials:
References:
Clinical trial NCT02649309: Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial
Official title: Effect of Single-cycle Remote Ischemic Preconditioning and Postconditioning on Myocardial Injury in Patients Undergoing Emergency and Elective Percutaneous Intervention in Phramongkutklao Hospital and Thammasat University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Reperfusion Injury
Keywords: Ischemic Preconditioning
Postconditioning
Angioplasty
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.


Eligibility criteria: Inclusion Criteria:

* Eligible for percutaneous coronary intervention (elective and emergency cases)
* Age \> 18-year-old
* Informed consent

Exclusion Criteria:

* Previous CABG
* Previous PCI in 1 week / treatment with thrombolysis within 30 days
* Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
* Paresis of upper limb
* Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
* Fatal cardiac arrhythmia (VT / VF)
* Chronic hypoxia

Primary outcomes:
measure: Change in cardiac Troponin-T from baseline
timeFrame: within 24 hours
Secondary outcomes:
measure: Incidence of myocardial injury
timeFrame: within 24 hours
measure: Major adverse cardiovascular events (MACE) in each intervention group
timeFrame: 6 months
measure: Incidence of myocardial injury in differrent subgroups of patient characteristics
timeFrame: within 24 hours
measure: Incidence of myocardial injury in patients with vs. without RIPre and RIPost
timeFrame: 24 hours
measure: Incidence of MACE in differrent subgroups of patient characteristics
timeFrame: 6 months
measure: Incidence of MACE in patients with vs. without RIPre and RIPost
timeFrame: 6 months
measure: Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Internal Medicine
Study officials:
affiliation: Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand
name: Nakarin Sansanayudh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02103309: Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan
Official title: Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Myopic Astigmatism
Keywords: Soft contact lenses
DACP
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-04-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.


Eligibility criteria: Inclusion Criteria:

* Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
* Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
* Those who play ball sports at least 1 day per week
* Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Those who regularly wear the study device
* Those who require ocular treatment with eye drops
* Those who have a condition contraindicating soft contact lens wear, such as eye irritation
* Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
* Those who are participating in another clinical study or research or have a plan of such participation during the present study
* Women who are pregnant or intend to become pregnant during the study
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean Investigator-Rated Lens Centration
timeFrame: After 1 week of wear
Secondary outcomes:
measure: Mean Investigator-Rated Lens Fit
timeFrame: After 1 week of wear
measure: Average Subjective Ratings Score (Lens Handling and Overall Vision)
timeFrame: After 1 week of wear
measure: Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
timeFrame: After 1 week of wear
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Lisa L. Zoota, MPH, CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04347109: cArdiac Non Invasive MApping in resynchronizaTION
Official title: cArdiac Non Invasive MApping in resynchronizaTION Registry
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cardiac Resynchronization Therapy
Keywords: non invasive mapping
cardiac resynchronization therapy
pacing-induced cardiomyopathy
electrical shock
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred for change or upgrading of a right ventricular pacing device in our center (CHU Tours).

Brief summary: Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.

Detailed description: Non-invasive mapping using the Cardio Insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy.

Control patients are included, requiring chronic permanent right ventricular pacing.

Specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.

Eligibility criteria: Inclusion Criteria:

* Patients implanted with a biventricular pacing device (CRT) device
* Patients chronically implanted with a right ventricular pacing device.

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: Ventricular activation map
timeFrame: Up to 6 months
measure: Response to CRT
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
state: Please Select...
Study officials:
References:
Clinical trial NCT00726609: Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Official title: Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycoses
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with invasive fungal infection refractory to first-line treatment or unable to tolerate it were selected at hospitals in Germany.

Following the enlargement of the marketing authorization for posaconazole, subjects at risk for invasive fungal infection were also enrolled.

Brief summary: The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.

Detailed description: Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs \& symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms.

This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety.

Eligibility criteria: Inclusion Criteria:

Adult subjects with:

* Invasive aspergillosis refractory to, or intolerant of, amphotericin B or itraconazole,
* Fusariosis refractory to, or intolerant of, amphotericin B,
* Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole,
* Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or fluconazole.
* Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections.
* Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for Graft-versus-host disease and who are at high risk for developing invasive fungal infections.

Exclusion Criteria:

* Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.

Primary outcomes:
measure: Number of Participants Reporting Adverse Drug Reactions.
timeFrame: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06277609: A Trial Investigating Lu AF28996 in Healthy Adult Participants
Official title: Interventional, Open-label, Repeated Single-dose Trial Investigating the Effects of Enzyme Inhibition on the Pharmacokinetic Profile of Lu AF28996 and Its Metabolites in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.

Detailed description: The study has 2 parts: Part A and Part B.

Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors.

Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.

Eligibility criteria: Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m\^2) at the Screening Visit and at the Safety Baseline Visit.
* The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Safety Baseline Visit.
* The participant has a resting supine systolic blood pressure ≥90 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥50 and ≤90 mmHg at the Screening Visit and at the Safety Baseline Visit.
* The participant has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.

Exclusion Criteria:

* The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
* Part B only, the participant is a woman of childbearing potential AND is using oral hormonal contraceptives.
* The participant has previously been enrolled in this trial.
* The participant has previously been dosed with Lu AF28996.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of Lu AF28996
timeFrame: Predose to Day 13
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996
timeFrame: Predose to Day 13
Secondary outcomes:
measure: Nominal Time Corresponding to the Occurrence of Cmax
timeFrame: Predose to Day 13
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas CRU
state: Texas
Study officials:
References:
Clinical trial NCT02142309: Glycemic Durability After Metformin Failure
Official title: Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 450
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of \<7%.

AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.

Detailed description: * Source data verification: paper or electronic medical records.
* Statistical analysis: All analyses will compare the randomly assigned treatment groups under the intention- to-treat principle

Eligibility criteria: Inclusion Criteria:

* Newly-diagnosed, type 2 diabetic patients, failing to diet

Exclusion Criteria:

* Suspected type 1 diabetes or secondary diabetes resulting from specific causes
* Current or previous (within past 3 months) treatment with any investigational drug
* Any major cardiovascular event in previous year
* Plans for pregnancy during the course of the study for women of childbearing potential
* Serum creatinine level \>1.3 mg/dL in women and \>1.4 mg/dL in men
* History of cancer, other than nonmelanoma skin cancer, that required therapy in the 5 years before randomization
* Treatment with oral, loal, systemic glucocorticoids 14. Treatment with atypical antipsychotics

Primary outcomes:
measure: The primary outcome is maintenance of metabolic control (glycemic durability), defined as time to primary failure with a HbA1c value >7% on maximally tolerated doses of the assigned drug.
timeFrame: Six years
Secondary outcomes:
measure: Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up
timeFrame: 6 years
Other outcomes:
measure: Changes of low density lipoprotein cholesterol level from baseline each year of follow up
timeFrame: 6 years
measure: Changes of high density lipoprotein cholesterol level from baseline each year of follow up
timeFrame: six years
measure: Changes of triglyceride level from baseline each year of follow up
timeFrame: 6 years
Locations:
city: Naples
country: Italy
facility: Department of Geriatrics and Metabolic Diseases
city: Naples
country: Italy
facility: Katherine Esposito
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Dario Giugliano, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03360409: Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph
Official title: Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Disc Degeneration
Keywords: Cervical Disc Degeneration
cervical anterior discectomy
Spinal alignment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

Detailed description: This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.

Eligibility criteria: Inclusion Criteria:

* patients with arm pain not responding to conservative treatment
* lasted longer than 10 weeks
* single level disc degeneration
* mobile spine on dynamic lateral cervical X-rays

Exclusion Criteria:

* severe cardiopulmonary comorbidity
* suspected underlying malignant disease
* radicular syndrome
* spinal-cord compression syndrome
* contraindication for radiography

Primary outcomes:
measure: change of cervical alignment
timeFrame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
Secondary outcomes:
measure: quality of life
timeFrame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
Other outcomes:
Locations:
Study officials:
affiliation: PekingUPH department of spinal surgery
name: zhenqi zhu
role: STUDY_DIRECTOR
References: