louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04011488: Shared Decision Making and How It Impacts the Patient Understanding
Official title: Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: shared decision making
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Johns Hopkins University
name: 3rd Coast Research Associates
name: Yale University
name: University Hospitals Cleveland Medical Center
name: PIH Family Practice Residency
name: Baylor College of Medicine
name: Zimmer Biomet
First posted: 2019-07-08
Enrollment: 108
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis.

1. Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women?
2. Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
3. What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?


Eligibility criteria: Inclusion Criteria:

* - Aged 45 to 64 years
* Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician
* Self-identified as African American and/or Hispanic
* At least one of the following comorbidities:

  1. Obesity (BMI ≥ 30),
  2. Hypertension (ICD10 codes below)
  3. Diabetes (ICD10 codes below)

Exclusion Criteria:

* - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
* Prior total knee replacement
* Recommended total knee replacement
* Acute knee trauma

Primary outcomes:
measure: Patient Information Survey
timeFrame: One month afterwards
Secondary outcomes:
measure: Personal Health Questionnaire (PHQ-8),
timeFrame: One month post intervention
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)
timeFrame: One month post intervention
measure: Patient Experience Survey
timeFrame: One month post intervention
measure: Patient Information Survey- Qualitative portion
timeFrame: One month post intervention
measure: Shared Decision Making (SDM) Survey
timeFrame: One month post intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Michael L. Parks, MD
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Michael L Parks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062188: VAlidity and Reliability of the Telephone Interview Form for Stroke Outcome Evaluation
Official title: Development and Validation of the Telephone Interview Form for Stroke Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke outcomes
Telephone interview
Modified Rankin Scale questionnaire
Barthel Index questionnaire
Validity study
Reliability study
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are clinically stable stroke patients with the course between 1 to 12 months.

Brief summary: The investigators combined the mRS questionnaire and BI questionnaire and then developed a telephone interview form as a simple questionnaire with internal rules. The main purpose of this study is to evaluate the validity and reliability of the telephone interview form when compared with face-to-face assessment in clinically stable patients with stroke.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of ischemic or hemorrhagic stroke.
* The course of 1 to 12 months.
* Patient or procuratorial caregiver has a good understanding so as to answer rater's telephone interview.
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Patients with psychological or mental disorders.
* Patients suffer from other so severe diseases that they can't complete the follow-up.

Primary outcomes:
measure: Criterion validity of the Telephone Interview Form
timeFrame: Baseline, 3 days after baseline, 6 days after baseline
measure: Inter-rater reliability of the Telephone Interview Form
timeFrame: 3 days after baseline, 6 days after baseline
Secondary outcomes:
measure: Sensitivity of Telephone Interview Form
timeFrame: 3 days after baseline, 6 days after baseline
measure: Specificity of Telephone Interview Form
timeFrame: 3 days after baseline, 6 days after baseline
measure: Internal consistency reliability of Barthel Index questionaire in Telephone Interview Form
timeFrame: Baseline, 3 days after baseline, 6 days after baseline
measure: Convergent validity of Telephone Interview Form
timeFrame: Baseline, 3 days after baseline, 6 days after baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital affiliated to Beijing University of Chinese
name: Ying Gao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594788: Neutrophil Gelatinase-associated Lipocalin as a New Biomarker to Detect Acute Kidney Injury in Postoperative Cardiac Surgery
Official title: NGAL as a Marker of Acute Kidney Injury After Cardiac Surgery. Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalised patients

Brief summary: Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).


Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years proposed for cardiac surgery with / without CPB.
* Accepting to participate in the study, with informed consent signed by the patient, guardian or family member.

Exclusion Criteria:

* Patients \< 18 years.
* Patients do not agree to participate in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT06858488: Bioimpedance for Ortho Trauma
Official title: A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Soft Tissue Injury Following High Energy Extremity Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma Injury
Keywords: Orthopedics
Extremity fracture
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2025-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with high-energy extremity trauma will undergo imaging with an EIT device in the Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms. The EIT device is an electrical impedance tomography system.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* High energy closed extremity fracture
* Provision of informed consent

Exclusion Criteria:

* Metatarsal fractures
* Injury to both lower extremities precluding contralateral imaging
* Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
* Currently pregnant, potentially pregnant, or lactating women

Primary outcomes:
measure: Feasibility and acceptability of the EIT device
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ida L Gitajn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00134888: Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
Official title: The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Opioid Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-08-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.

Detailed description: Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.

This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.

Eligibility criteria: Inclusion Criteria:

* Meets diagnostic criteria for opioid dependence
* Qualifies for opioid substitution treatment (e.g., methadone)

Exclusion Criteria:

* Significant psychiatric or physical disorder

Primary outcomes:
measure: Physiological effects
timeFrame: up to one day
measure: drug effects (measured at Week 11)
timeFrame: up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937988: Patient Support During Surgical Abortion
Official title: Patient Support During Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Abortion
Keywords: Doula
Abortion
Pain
support
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a non-blinded randomized controlled trial (RCT) of women presenting for abortion at \<13 6/7 weeks. Women will be randomized either to receive support by a trained abortion doula (intervention) or to have standard procedure (control) during the abortion procedure. The investigators hypothesize that women who receive doula support during a first trimester abortion will report less pain during the abortion procedure compared to women who do not receive abortion doula support.


Eligibility criteria: Inclusion Criteria:

* Aged \> 18 years
* Gestational age by sonogram \< 13 6/7 weeks gestation
* Desires pregnancy termination
* Ability to understand the study and give informed consent
* Ability to read and comprehend informed consent document in English

Exclusion Criteria:

* Aged \< 18 years
* Gestational age by sonogram \> 13 6/7 weeks gestation
* Inability to understand the study and give informed consent
* Inability to read and comprehend informed consent document in English

Primary outcomes:
measure: Pain at time of procedure
timeFrame: At time of procedure
Secondary outcomes:
measure: Satisfaction with procedure
timeFrame: 10 minutes post-procedure
measure: Difficulty of procedure
timeFrame: Immediately post-procedure
measure: Duration of procedure
timeFrame: During procedure
measure: Pain at time of speculum insertion
timeFrame: At time of speculum insertion
measure: Anticipated pain
timeFrame: Prior to procedure
measure: Pre-procedure anxiety
timeFrame: Prior to procedure
measure: Post-procedure recalled pain
timeFrame: Post-procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
Study officials:
References:
Clinical trial NCT05120388: Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
Official title: Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: GDM
Extra Virgin Olive Oil
lipid profile
insulin requirement
postpartum reclassification
Lead sponsor: Center for Pharmacological and Botanical Research
Sponsor class: OTHER_GOV
Collaborators: name: Sociedad Argentina de Diabetes
First posted: 2021-11-15
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
Primary purpose: PREVENTION

Brief summary: Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.

Detailed description: This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.

Eligibility criteria: Inclusion Criteria:

* GDM (diagnosis criteria of the Latin American Society of Diabetes (ALAD) and Argentine Society of Diabetes (SAD): Fasting plasma glucosa \> 100 mg/dl, p75 oral glucose tolerance test-2 h plasma glucose \> 140 mg/dl)

Exclusion Criteria:

* Multiple pregnancy
* Pregestational diabetes (type 1 or type 2)
* Bariatric surgery
* Infectious diseases

Primary outcomes:
measure: maternal triglyceridemia
timeFrame: term pregnancy
measure: maternal weight gain
timeFrame: change from prepregnancy weight to term pregnancy weight
measure: number of participants with insulin requirement
timeFrame: term pregnancy
Secondary outcomes:
measure: number of participants with diabetes at postpartum
timeFrame: six weeks postpartum
Other outcomes:
Locations:
city: Neuquén
country: Argentina
facility: Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo
state: Neuquen
Study officials:
References:
Clinical trial NCT05746988: Carrageenan for the Prevention of Oral HPV Infection
Official title: Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Oral HPV infection
Mouthwash
Carrageenan
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a single in-person visit at baseline, filling out a questionnaire on their electronic device and giving an oral rinse sample for HPV testing. They will receive an adequate supply of mouthwash and instructions on its use. They will subsequently be followed up for up to six months. Every two weeks, participants will fill out a follow-up questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample to be returned by mail.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 45 years old
* Sexually active and have had oral sex in the past month
* Will be residing in Montreal for the next six (6) months after study enrolment

Exclusion Criteria:

* Previous vaccination against HPV
* Previous cancer of the mouth or throat

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 year
measure: Drop-out rate
timeFrame: 1 year
measure: Adherence rate for mouthwash use
timeFrame: 6 months
measure: Adherence rate for self-sampling
timeFrame: 6 month
measure: Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
timeFrame: 6 months
Secondary outcomes:
measure: Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
timeFrame: 6 months
Other outcomes:
measure: Time to oral HPV infection
timeFrame: 6 months
measure: Time to oral HPV clearance
timeFrame: 6 months
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Belinda Nicolau, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329988: Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.
Official title: Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unhealthy Alcohol Use
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population consulting in a primary care office over 18 years old.

Brief summary: Unhealthy alcohol use (UAU) is a very important public health concern. In France UAU is the second cause of avoidable death after tobacco smoking. In 2014, 31% of the French adult population presented with unhealthy alcohol use. Primary care practitioners have access to validated questionnaires in French such as the Alcohol Use Disorder Identification Test (AUDIT) and the Fast Alcohol Consumption Evaluation (FACE). These tests are not often used because of their length.

In 2009 a study by Smith et al in the USA compared a single question with the AUDIT-c (a short version of the AUDIT). The single question was "How many times in the past year have you had X or more drinks in a day?" Where X is 7 for men and 6 for women. This study found that the single question had a comparable sensitivity and a specificity, respectively 81,8% and 79,3%.

The aim of the study is to validate this question in French. First the question has been translated from English to French following the WHO method. The aim of the present study is to validate the French translation by comparing it with the AUDIT and the FACE. A questionnaire will be given to patients with inclusion criteria in general practitioners waiting rooms (15 different locations). This questionnaire will be composed of the single question, followed by the AUDIT and FACE, and three socio-demographic questions. The questionnaire will be anonymous.


Eligibility criteria: Inclusion Criteria:

* Consulting in a general practitioner's office
* Over 18 years Old

Exclusion Criteria:

* Less than 18 years old
* Pregnant women or breast-feeding mothers
* People under legal protection

Primary outcomes:
measure: sensitivity of the single question
timeFrame: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).
measure: specificity of the single question
timeFrame: At inclusion (Patients will answer the questionnaire only once while waiting in theirs doctor's waiting room).
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Quentin-Fallavier
country: France
facility: Cabinet de Médecine Générale Dr Christine Maynie-François
Study officials:
References: