louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04716621: Computerized Decision Support Tool for Pain Management in Primary Care
Official title: Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: MJHS Institute for Innovation in Palliative Care
Sponsor class: OTHER
Collaborators: name: Pfizer
name: The Institute for Family Health
First posted: 2021-01-20
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.

The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.

Detailed description: This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.

Eligibility criteria: Inclusion Criteria:

1. Treated at the Institute for Family Health
2. Spoke English or Spanish
3. Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
4. Pain screening at the prior three office visits documented scores \>3 on the 0-6 scale (FACES, Hicks et al., 2001).
5. Willingness to complete questionnaires three times
6. A commitment to return to the practice
7. Reachable by phone
8. No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments

Exclusion Criteria:

-

Primary outcomes:
measure: Worst Pain Intensity
timeFrame: From baseline to 6 months following intervention implementation
measure: Average Pain Intensity
timeFrame: From baseline to 6 months following intervention implementation
measure: Pain Interference with Function
timeFrame: From baseline to 6 months following intervention implementation
Secondary outcomes:
measure: Worst Pain Intensity
timeFrame: From 6 to 12 months following intervention implementation
measure: Average Pain Intensity
timeFrame: From 6 to 12 months following intervention implementation
measure: Pain Interference with Function
timeFrame: From 6 to 12 months following intervention implementation
measure: Uptake of the PMSS-PC intervention tool
timeFrame: From baseline to 12 months following intervention implementation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00213421: Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Pemphigoid
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with compatible bullous pemphigoid clinical exam

Brief summary: to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* immunoflurescence, histological exam, predictive value according to bullous pemphigus diagnostic
* consentment patient

Exclusion Criteria:

* age \< 18
* no consentment
* localized bullous pemphigus (\<400cm2)
* linear IgA pemphigus
* corticothérapy, immunotherapy
* pregnant woman pemphigus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH-rouen
state: Seine maritime
Study officials:
affiliation: UH Rouen
name: Pascal Joly, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01085721: Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
Official title: Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Viral Infections of the Upper Respiratory Tract
Keywords: allergic rhinitis
viral infections of the upper respiratory tract
dexchlorpheniramine
pseudoephedrine
guaifenesin
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production.

The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.


Eligibility criteria: Inclusion Criteria:

* Patients with allergic rhinitis with symptoms of viral infection of the upper respiratory tract (rhinorrhea, nasal obstruction and productive cough)
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent
* Patients who did not use forbidden medications

Exclusion Criteria:

* History of allergy to any component of the formulations
* Use of any investigational drug within the last 30 days
* Patients with bacterial infections of the upper respiratory tract
* Patients with high blood pressure (\> 140 x 90 mmHg)
* Patients who are receiving inhaled beta-agonists or other antihistamine, decongestant or expectorant
* Patients with known pulmonary disease (asthma, COPD, neoplasias)
* Pregnancy
* HIV + patients
* Other conditions considered by the investigator as reasonable for non-eligibility

Primary outcomes:
measure: Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
timeFrame: 5 days
Secondary outcomes:
measure: Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03801421: Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision
Official title: Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Suture, Complication
Keywords: Surgical Wound
Suture, Complication
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 2000
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: A better suture technology will reduce postoperative incision complications. This study is designed to compare mass continous suture with PDS and interrupted suture with thread on major abdominal incision.

Detailed description: A better suture technology will reduce postoperative incision complications. The previous retrospective cohort study from the investigator has demonstrated that continuous mass suture with PDS led to shorter incision closure time, early wound healing and comparable incisional complications versus interrupted thread suture. As such, the current RCT study will include 100 subjects with major abdominal incision. They will be divided into two groups randomly: Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with thread. The wound healing time, stitches removal time and incidence of incision complications will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* the patient with major abdominal incision.
* the incision is longer than 10 cm
* aged between 18 to 65 years old

Exclusion Criteria:

* Pregnant woman
* Patient with diabetes
* Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
* Severe lung diseases such as COPD and asthma
* Patients undergoing emergent or infectious surgery
* Patients with surgical site infection
* No autonomy, inability or unwillingness to participate in follow-up

Primary outcomes:
measure: healing time, d (day)
timeFrame: Up to 1 month after surgery
Secondary outcomes:
measure: incidence of incision complications
timeFrame: Up to 1 month after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Xu-Feng Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01607164: Healthy Mood Internet Recruitment Study
Official title: Depression Prevention and Management Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recruitment
Keywords: Mood management
self-help
depression
prevention
cognitive behavioral
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-05-28
Enrollment: 1226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is pilot testing a self-help automated Website (similar to a self-help book) designed to help individuals to learn methods to manage their mood. The methods are cognitive-behavioral skills found effective in the treatment of depression when provided by live therapists. The purpose of the study is to determine the number of individuals who will visit the site, use the site, and respond to online surveys reporting their mood levels while using the site, and at 1, 3, and 6 months after starting to use the site. The investigators want to eventually examine whether learning these methods online would help prevent depression.

Detailed description: Self-help automated website in Spanish and English consisting of an 8-lesson course on mood management based on cognitive behavioral methods.

Accessible via the web.

Follow-up assessments conducted at 1, 3, and 6 months.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* valid email address
* fluent in English

Exclusion Criteria:

* less than 18 years of age
* no valid email address
* not fluent in English

Primary outcomes:
measure: Recruitment
timeFrame: One year
Secondary outcomes:
measure: PHQ-9
timeFrame: Screening, plus 1, 3, and 6 months later
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psychiatry at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ricardo F Muñoz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munoz RF, Beardslee WR, Leykin Y. Major depression can be prevented. Am Psychol. 2012 May-Jun;67(4):285-95. doi: 10.1037/a0027666.
Clinical trial NCT01032564: Interest of HI-RTE Elasticity in Obstetric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 73
Sex: FEMALE
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: DIAGNOSTIC

Brief summary: In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.

If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.

The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.

Its contribution in obstetric must be estimated to improve patients minimum fare.

The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women


Eligibility criteria: Inclusion Criteria:

* Unique(only) or multiple pregnancy about is the term presenting an intra Utérine pregnancy in the 1st quarter ·
* Signed lit(enlightened) consent ·
* Patient of more than 18 years old

Exclusion Criteria:

* Suspicion of pregnancy extra utérine, hémodynamique unstable, important métrorragies, maternal diabetes, arterial high blood pressure

  * impossibility to receive the consent lit(enlightened) by the patient · patient old under age 18

Primary outcomes:
measure: The elastography (elasticity imagery)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Florence BRETELLE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sabiani L, Haumonte JB, Loundou A, Caro AS, Brunet J, Cocallemen JF, D'ercole C, Bretelle F. Cervical HI-RTE elastography and pregnancy outcome: a prospective study. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:80-4. doi: 10.1016/j.ejogrb.2015.01.016. Epub 2015 Jan 23.
Clinical trial NCT01536964: The Effect of Morphine on Prasugrel Absorption in STEMI Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2012-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Heart Attacks are a major cause of death in this country. When patients have a heart attack, they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is important that Prasugrel starts to work as quickly as possible following a heart attack. As many patients who have a heart attack experience excruciating pain, they are often given morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend to study the effect of morphine on the absorption of Prasugrel.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age and willing and able to provide informed consent
* Admission to hospital with a STEMI \>12 months prior to recruitment
* Previous prasugrel and morphine use with no adverse effect

Exclusion Criteria:

* Active respiratory disorder, resting oxygen saturation \< 95% or decompensated congestive cardiac failure
* Current use of anti-platelet or anti-coagulant drugs apart from aspirin 75 mg daily, or receipt of any dose of clopidogrel, prasugrel or ticagrelor in the last 2 weeks
* Current use of opiate analgesia

Primary outcomes:
measure: VerifyNow P2Y12 PRU measurement at 2 hours post dose
timeFrame: 2 hours
Secondary outcomes:
measure: Estimated time to PRU less than 150; maximal LTA response to ADP 20 microM at 2 hours post dose; final LTA response to ADP 5 microM at 2 hours post dose.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
References:
Clinical trial NCT02887664: The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants
Official title: The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small for Gestational Age Infants
Appropriate for Gestational Age Infants
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-09-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers of term or or near term infants after delivery

Brief summary: Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy and lactation for the prevention of preterm birth, beneficial effects on fetal development, visual and cognitive development and other functional outcomes of the infants.

The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid and inflammation markers in SGA infants compared with appropriate for gestational age (AGA) infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid concentrations in cord blood will differ from those observed in AGA and might correlate with the level of circulating mediators.


Eligibility criteria: Inclusion Criteria:

* Mothers of SGA infants ( above 35 week of gestation)
* Mothers of term and near-term AGA infants

Exclusion Criteria:

* Maternal chronic diseases, smoking, diabetes, alcohol use, pregnancy-associated hypertension and pre-eclampsia
* Neonatal depression
* Congenital malformations
* Intrauterine infections
* Chromosomal aberrations
* Mothers interested in cord blood banking

Primary outcomes:
measure: Cord blood analysis
timeFrame: at time of delivery
Secondary outcomes:
measure: Maternal blood analysis
timeFrame: at time of delivery
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky medical center (Ichilov)
Study officials:
affiliation: Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
name: Dror Mandel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02467764: "Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis
Official title: Definition of a "Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: Knee
Knee osteoarthritis
Knee replacement
Hip
Hip osteoarthritis
Hip replacement
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.

Brief summary: The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions commonly make a significant improvement in the quality of life of patients. Infection can occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not infected character directly influences the surgical conduct. It is therefore recommended that the positive or negative diagnosis is made in the most reliable way possible, but no single element only allows a low diagnosis. The concomitant use of several clinical, radiological and aggregated into a composite score history could help facilitate this preoperative approach during reoperation on prosthetic joint


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: define a composite score on total Hip or Knee Prosthesis
timeFrame: patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426164: Liposomal Bupivacaine in Total Knee Arthroplasty
Official title: Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Arthroplasty, Replacement, Knee
Osteoarthritis
Lead sponsor: Miller Orthopedic Specialists
Sponsor class: OTHER
Collaborators: name: Creighton University Medical Center
name: CHI Health Mercy Hospital
First posted: 2015-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial

Exclusion Criteria:

* Patients with a sensitivity to marcaine
* Pregnant or lactating women
* Non-English speaking individuals

Primary outcomes:
measure: Mean visual analog scale (VAS) pain scores
timeFrame: Night of surgery
measure: Mean visual analog scale (VAS) pain scores
timeFrame: Post-operative day 1
measure: Mean visual analog scale (VAS) pain scores
timeFrame: Post-operative day 2
measure: Pain assessment phone call
timeFrame: Post-operative day 3
Secondary outcomes:
measure: Complications
timeFrame: Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.
Other outcomes:
Locations:
city: Council Bluffs
country: United States
facility: Miller Orthopedic Specialists
state: Iowa
Study officials:
affiliation: Miller Orthopedic Specialists
name: Clifford K Boese, MD
role: PRINCIPAL_INVESTIGATOR
References: