louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01182480: Chronic Care Management/Patient Relationship Management Proof of Concept
Official title: Chronic Care Management/Patient Relationship Management Proof of Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Microsoft Corporation
name: EMC Consulting
First posted: 2010-08-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This proof of concept study proposes to evaluate the feasibility of a communications-technology-based chronic care and patient relationship management program to improve diabetes self management among adult diabetic patients in an urban safety net population by providing between-visit reminders and chronic disease support through cell phone text messaging.

The investigators hypothesize that diabetic patients enrolled in the program will be less likely to miss scheduled appointments and will have greater perceived self-efficacy and improved patient satisfaction concerning chronic disease management. No-show rates among patients enrolled in the program are expected to be lower than among patients receiving standard care.


Eligibility criteria: Inclusion Criteria:

* patients with diabetes
* receive care at a primary care clinic in the DH system
* between 18 and 76 years of age
* primary language of English or Spanish
* ownership of a qualifying cell phone (SMS text capable)
* ownership of a glucometer.

Exclusion Criteria:

* life expectancy less than six months,
* do not have or cannot use a phone or glucometer
* do not want to participate

Primary outcomes:
measure: Patient Engagement
timeFrame: 3 months
Secondary outcomes:
measure: Appointment Attendance
timeFrame: 3 months
measure: Perceived Self-efficacy
timeFrame: 3 months
measure: Glycemic Control
timeFrame: 3 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Andrew W Steele, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer HH, Moore SL, Ginosar D, Davidson AJ, Rice-Peterson CM, Durfee MJ, MacKenzie TD, Estacio RO, Steele AW. Care by cell phone: text messaging for chronic disease management. Am J Manag Care. 2012 Feb 1;18(2):e42-7.
Clinical trial NCT01304862: Electronic Self-management Resource Training for Mental Health
Official title: Electronic Self-management Resource Training for Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Generalized Anxiety Disorder
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills.

Detailed description: Each year, more than four million young adults (age 18-25 years old) in the U.S. receive psychotropic medication or psychotherapy as treatment for a mental illness. One in every four of these young adults will disengage from mental health treatment before significant symptom remission is achieved. Mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills. Electronic self-management resource training for mental health (eSMART-MH) is an innovative use of avatars-virtual persons who tailor responses to users-to improve mental health treatment disengagement.

Eligibility criteria: Inclusion Criteria:

* Self-report of a diagnosis depression or generalized anxiety disorder greater than six months
* Young adults 18-25 years of age
* Prescribed psychotropic medication and/or psychotherapy
* Have a documented domestic telephone number
* Able to read and understand English

Exclusion Criteria:

* Participation in the eSMART-HD parent project

Primary outcomes:
measure: Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM)
timeFrame: 12 weeks
Secondary outcomes:
measure: Mental Illness Stigma: Alienation Subscale
timeFrame: 12 weeks
measure: Mental Health Literacy: In Our Own Voice Knowledge Measure (IOOVKM)
timeFrame: 12 weeks
measure: Patient Activation: Patient Activation Measure (PAM)
timeFrame: 12 weeks
measure: Effective Communication: Patients' Self-Competence Subscale (PSC)
timeFrame: 12 weeks
measure: Symptom Severity: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Feasibility and Acceptability of Intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Frances Payne Bolton School of Nursing
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Melissa D Pinto-Foltz, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896362: The Healthcare Professionals and the Leishmaniasis
Official title: Leishmaniasis: the Healthcare Professionals' Knowledge in Endemic Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge on Leishmaniasis
Lead sponsor: Centro de Pesquisas René Rachou
Sponsor class: OTHER_GOV
First posted: 2013-07-11
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses, physicians and dentists working in primary care units of the municipality, community health workers and zoonoses agents tied to health surveillance and veterinarians working in private veterinary clinics of Divinópolis city, Minas Gerais state, Brazil.

Brief summary: The aim of this work was to investigate the healthcare professionals' knowledge about leishmaniasis in Divinópolis, an endemic county of Minas Gerais state, Brazil.


Eligibility criteria: Inclusion Criteria:

* work in the healthcare centers, in the case of primary care professionals;
* have a university degree for nurses, physicians, dentists and veterinarians;
* be working effectively at the time of the interview;
* accept the terms of the research through written informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of questions correctly answered
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Pesquisas René Rachou
name: Carina M de Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03542162: Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment
Official title: Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Keywords: Healaflow
Rhegmatogenous retinal detachment
27-gauge Pars plana vitrectomy
Minimally invasive surgery
Complications
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients who meet the criteria and agree to paticipate in the clinical study, will be enrolled to this study after signing informed consent.
Primary purpose: TREATMENT

Brief summary: To report the surgical results of primary rhegmatogenous retinal detachment (RRD) repaired by 27G pars plana vitrectomy (PPV) combined with Healaflow patch and air tamponade, and do not need prone position postoperation.

Detailed description: To improve the success rates of pars plana vitrectomy(PPV) which is the most common surgical procedure for the repair of primary rhegmatogenous retinal detachment (RRD) and to avoid silicon oil tamponade and face-down position, all eyes enrolled into this clinical trail undergo 27G PPV combined with Healaflow patch and air tamponade which do not need face-down position in the postoperative period. Healaflow® (Anteis S.A., Plan Les Ouates, Switzerland) consists of over 97% water, sodium hyaluronic acid (22.5 mg/ml) of nonanimal origin cross-linked with BDDE (1.4-Butanediol diglycidyl ether), and phosphate- and NaCl-salts to maintain a physiological pH (7.0) and osmolarity (305 mOsm/kg).

At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure(IOP) will be measured and fundoscopy, OCT, B-ultrasound will be performed.

The patients are going to be followed up for at least 3 months, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.

Eligibility criteria: Inclusion Criteria: - patients with primary RRD

Exclusion Criteria: - proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD

Primary outcomes:
measure: postoperative anatomic outcome
timeFrame: baseline to 3 months post-surgery
Secondary outcomes:
measure: BCVA
timeFrame: baseline to 3 months post-surgery
measure: postoperative complications
timeFrame: baseline to 3 months post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: Xiaorong Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00565162: Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus
Official title: A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating Lantus(Insulin Glargine) Therapy to Determine Metabolic and Economic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 124
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 introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.


Eligibility criteria: Inclusion Criteria:

* Insulin-naive Type 2 Diabetes Mellitus subjects, aged ≥18 years and on stable oral anti-diabetic treatment for \>6 months requiring basal long-acting insulin (HbA1c \>7.5 % and \<12.0 %).

Exclusion Criteria:

* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Superiority is based on observing clinically significant difference in glycaemic control (> than or = to 0,5 % HbA1c). Programs are defined as equally successful if the HbA1c differs less than 0,5 %.
timeFrame: HbA1c values at visits 1, 2, 5 and 10
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Sanofi-Aventis
city: Amsterdam
country: Netherlands
facility: Sanofi-Aventis
city: Stockholm
country: Sweden
facility: Sanofi-Aventis
city: Leicester
country: United Kingdom
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Sanni Lahdenpera
role: STUDY_DIRECTOR
References:
citation: Yki-Jarvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenpera S, Nijpels G, Vahatalo M. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diabetes Care. 2007 Jun;30(6):1364-9. doi: 10.2337/dc06-1357. Epub 2007 Mar 23.
Clinical trial NCT00754962: Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-way Crossover Bioequivalency Study of Protriptyline Tablets 10 mg Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Protriptyline or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: baseline, 2-period, 28 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Advanced Biomedical Research
state: New Jersey
Study officials:
affiliation: Advanced Biomedical Research
name: Benno G Roesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03263962: Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure (the Coffee-it Study)
Official title: Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Heart Failure Patients
Keywords: CHF
Canrenone
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CHF and preserved systolic function with or without an aldosterone antagonist as canrenone.

Brief summary: To evaluate canrenone effects compared to other therapies on cardiovascular mortality in patients with congestive heart failure and preserved systolic function after 12 years of evaluation.

Detailed description: The investigators will verify patients with cardiac heart failure (CHF) and preserved systolic function and each patient must have all clinical evaluation through basal measurements of blood pressure, heart rate, biochemical tests, and color Doppler echocardiographic parameters for at least 12 years.

The investigators will evaluate the effects of an aldosterone antagonist as canrenone compared to a group without canrenone and the investogators will verify how many patients reported cardiovascular mortality or will survive.

Eligibility criteria: Inclusion Criteria:

* patients with CHF
* preserved systolic function (FE ≥ 45%)

Exclusion Criteria:

* severe hypertension identified by blood pressure ≥180/110 mmHg
* patients with impaired systolic function (FE \< 45%)
* history of active hepatitis or cirrhosis
* impaired renal function
* hyperpotassemia
* diabetes

Primary outcomes:
measure: Progression of CHF
timeFrame: 12 years
measure: Haemodynamic data
timeFrame: 12 years
measure: Metabolic data
timeFrame: 12 years
measure: Renal function
timeFrame: 12 years
measure: Endocrine data
timeFrame: 12 years
measure: Cardiovascular mortality
timeFrame: 12 years
measure: Survival
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT00259662: High-dose Periop Statins for Prevention of DVT
Official title: High-dose Statin Therapy in the Perioperative Period and DVT Prevention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Oncological Pelvic/Abdominal Surgery
Keywords: cancer--ovarian
cancer--endometria
deep vein thrombosis
statin therapy in perioperative period
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Washington Mutual Foundation
First posted: 2005-11-29
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory responses and deep vein thrombosis formation when given in high doses in the perioperative period.


Eligibility criteria: Inclusion Criteria:

* gynecologic tumor scheduled for resection

Exclusion Criteria:

* prior reaction to statins
* renal insufficiency
* liver disease
* h/o alcoholism
* prior h/o DVT or hypercoagulability
* concurrent medications that significantly affect cytochrome P450 3A4
* breast feeding or pregnancy

Primary outcomes:
measure: Decrease in incidence of deep vein thrombosis
Secondary outcomes:
measure: Decrease in inflammatory mediator release.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Assistant Professor
name: Ala S Haddadin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lippi G, Favaloro EJ, Sanchis-Gomar F. Venous thrombosis associated with HMG-CoA reductase inhibitors. Semin Thromb Hemost. 2013 Jul;39(5):515-32. doi: 10.1055/s-0033-1343892. Epub 2013 Apr 29.
Clinical trial NCT03500562: Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)
Official title: Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who receive branded DCV-based therapy in the real-world treatment setting for the first time under the approved indications.

Brief summary: Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy


Eligibility criteria: Inclusion Criteria:

* Participants 18 years of age and older
* Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label

Exclusion Criteria:

* Participants under the age of 18

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: Approximately 72 weeks
measure: Number of serious adverse events (SAEs)
timeFrame: Approximately 72 weeks
Secondary outcomes:
measure: Number of participants who discontinue therapy due to an AE
timeFrame: Approximately 72 weeks
measure: Effectiveness of daclatasvir DCV-based therapy
timeFrame: Approximately 72 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02755662: Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M CadCam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea (OSA) Therapy: ESTAMPS Study
Official title: Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M Cad Cam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea Syndrome (OSA) Therapy: ESTAMPS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive Sleep Apnea Syndrome
mandibular repositioning device
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: ESTAMPS is a randomized clinical trial with a crossover design:

Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume

secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning

Detailed description: Hypothesis ORCADES results suggest that Narval O.R.M CC could be more efficient than Narval MRD trad to reduce AHI whatever the initial OSA severity 79% of CC MRD patients have at least an AHI reduction of 50% (vs. 61% with a trad Narval MRD, p=0.0031) 66% of CC MRD patients get a complete answer with an AHI reduction \<10 (vs. 49% with a trad Narval MRD, p=0.0017) The investigators think that differences seen in the ORCADES study between the 2 MRD is due to a different impact on upper airway volume

Eligibility criteria: Inclusion Criteria:

* Patients with a mild OSA syndrome (5\<AHI\<30) and mild to moderate sleepiness without cardiac comorbidities or patients with mild to severe OSA syndrome (IAH\>15) who do not tolerate or refuse CPAP therapy
* Patients ≥ 18 years old
* Patient is able to fully understand study information and provide written informed consent

Exclusion Criteria:

* MRD contraindication
* Clinical trial classic exclusion criteria

Primary outcomes:
measure: upper airway volume
timeFrame: 1 month
Secondary outcomes:
measure: maximal mandibular propulsion
timeFrame: 1 month
measure: quality of sleep
timeFrame: 1 month
measure: sleepiness
timeFrame: 1 month
measure: MRD therapy efficacy
timeFrame: 1 month
measure: mandibular positioning
timeFrame: 1 month
measure: Occlusal vertical dimension
timeFrame: 1 month
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: CHU Rouen
name: Jean-Baptiste Kerbrat, MD
role: PRINCIPAL_INVESTIGATOR
References: