louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04568837: Steroids After Spine Fusion Surgery
Official title: Postoperative Steroids and Recovery After Spine Fusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spine Fusion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 420
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into one of two groups: treatment group vs control (no treatment) group
Primary purpose: TREATMENT

Brief summary: This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.

Detailed description: PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group.

OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic and/or lumbar spine fusion surgery at Oregon Health and Science University. Participants undergo their scheduled spine fusion surgery. After surgery, participants are randomized into either the study drug group or the control (non-treatment) group. If randomized into the study drug group, participants will orally take a daily dose of 20 mg of prednisone (1 mL of 4 mg/mL dexamethasone sodium phosphate if unable to tolerate oral administration) on postoperative days one and two.

Eligibility criteria: Inclusion Criteria:

* All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included

Exclusion Criteria:

* Patient is already taking chronic steroids
* Patient is pregnant
* Patient is decisionally impaired
* Patient is a prisoner

Primary outcomes:
measure: Morphine equivalent pain medication use over the length of hospitalization
timeFrame: From postoperative admission to discharge, up to 4 weeks
measure: Length of hospital stay after surgery
timeFrame: From postoperative admission to discharge, up to 4 weeks
measure: Time to first bowel movement in hospital after surgery
timeFrame: From postoperative admission to discharge, up to 4 weeks
measure: Number of major complications reported during hospital stay after surgery
timeFrame: From postoperative admission to discharge, up to 4 weeks
measure: Morphine equivalent pain medication use over the first 48 hours of hospitalization
timeFrame: From postoperative admission to 48 hours after
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Department of Orthopaedics and Rehabilitation
name: Jung U Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000237: Buprenorphine Detoxification - BBDVI - 19
Official title: Buprenorphine Detoxification - BBDVI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the long-term efficacy of alternate-day dosing schedules in promoting treatment compliance in the absence of confounding behavioral contingencies.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Weeks abstinent
measure: Weeks continuous abstinence
measure: Overall treatment outcome
measure: Opioid dependence and psychiatric status
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496637: A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen
Official title: A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Eating Disorders
Keywords: Obesity
Eating Disorders
Appetite regulation
Eating Regulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women. It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group. Appetite Awareness Training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.

Detailed description: All female freshmen students residing in the university dorms were recruited to participate in this study. After completing the baseline assessment, eligible participants were randomly assigned to one of the three arms. Those in the AAT condition received guided administration of AAT over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6). The standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician. A manualized approach to administration of the intervention was created based on the AAT treatment and was strictly followed in order to standardize the implementation of the prevention groups. The no-treatment control group only participated in the assessments.

Eligibility criteria: Inclusion Criteria:

* Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories

Exclusion Criteria:

* Males, non-dormitory residing, non-freshmen.

Primary outcomes:
measure: Change in Body Weight measured in pounds
timeFrame: Baseline, 6 weeks, 4 months
measure: Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)
timeFrame: Baseline, 6 weeks, 4 months
Secondary outcomes:
measure: Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
timeFrame: 6 weeks, 4 months
measure: Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire
timeFrame: 6 weeks, 4 months
Other outcomes:
Locations:
city: Duluth
country: United States
facility: University of Minnesota Duluth
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lara LaCaille, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224237: Exploring Folk Health Practices in Latinos With Chronic Medical Conditions
Official title: Exploring Folk Health Practices in Latinos With Chronic Medical Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypertension
Asthma
Heart Disease
Stroke
Arthritis
Keywords: Latino patients
Health practices
Culture influences
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be self-identified, adult Latino men and women from the community setting. The sample will comprise of a convenience sample from community-based organizations, including persons of Mexican, Puerto Rican, Cuban, Dominican, Central American, South American, or other Spanish-speaking culture.

Brief summary: This study will explore how culture influences the use of folk healing practices and medical services in Latinos with chronic medical conditions.

Detailed description: Sociocultural aspects of using ethnomedical health practices in a community-based Latino population will be described using both qualitative and quantitative survey methods. This study will rely heavily on its descriptive section, which will use in-depth, open-ended questions in a semi-structured personal interview format following qualitative research principles. It will also use closed-ended questions in a short survey format to begin to explore some variables that may be associated with using traditional healing practices. These variables include level of acculturation, degree of family social support, degree of adherence to standard medical regimens, perceived health status, presence of depressive symptoms, and severity of co-illnesses. These variables will be examined using common, validated scales.

Eligibility criteria: Inclusion Criteria:

Participants will be self-identified, adult men and women from the community setting. The sample comprise a convenience sample, including persons of Mexican, Puerto Rican, Cuban, Dominican, Central American, South American, or other Spanish speaking culture.

1. Latino men and women over the age of 18
2. Those self-identifying as having at least one chronic medical condition including:diabetes, hypertension, asthma, history of heart disease or stroke or musculoskeletal disease (arthritis).
3. Those reporting use of complementary or alternative therapies, including ethnomedical healing practices or practitioners.
4. Those who speak English or Spanish.

Exclusion Criteria:

Individuals who refuse to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jacqueline Duarte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622037: Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2008-02-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.


Eligibility criteria: Inclusion Criteria:

* Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
* Physician assessment of mild-moderate dry eye
* Patient willing to instill drops QID and complete entire length of protocol.
* TBUT \< 10 seconds
* BCVA of 20/30 or better

Exclusion Criteria:

* Current topical cyclosporine use (Restasis)
* Current Systane use
* Refractive surgery within the last 6 months
* Oral or topical corticosteroid use
* Severe dry eye patients by physician assessment
* current active Blepharitis
* Oral Doxycyclines use
* Oral Antihistamine use

Primary outcomes:
measure: Dry Eye Signs
timeFrame: 4 months
Secondary outcomes:
measure: Visual Quality
timeFrame: 4 months
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Florida Microsurgical Eye Institute
state: Florida
Study officials:
affiliation: Florida Microsurgical Eye Institute
name: Barry Schechter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03766737: Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children
Official title: Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children: Using a Human-in-the-loop Artificial Intelligence Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmopathy
Artificial Intelligence
Keywords: Vision Disorders
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Visual development during early childhood is a vital process. Examining the visual acuity of children is essential for the early detection of visual abnormality, but performing such an assessment in children is challenging. Here, the investigators developed a human-in-the-loop artificial intelligence (AI) paradigm that combines traditional vision examination and AI with integrated software and hardware, thus making the vision examination easy to perform. The investigator also establish a entity intelligent visual acuity diagnostic system based on the paradigm, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.


Eligibility criteria: Inclusion Criteria:

* Paediatric patients from eye clinic written informed consents provided

Primary outcomes:
measure: The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lin Haotian, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544037: BENEFIT Extension Study
Official title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 283
Sex: ALL
Minimum age (years): 23
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.

Brief summary: To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.


Eligibility criteria: Inclusion Criteria:

* All patients randomized and treated at least once in study 304747

Exclusion Criteria:

* Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study

Primary outcomes:
measure: To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
timeFrame: End of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Belgium
city: Many Locations
country: Canada
city: Many Locations
country: Czech Republic
city: Many Locations
country: Denmark
city: Many Locations
country: Finland
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Hungary
city: Many Locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Netherlands
city: Many Locations
country: Norway
city: Many Locations
country: Poland
city: Many Locations
country: Slovenia
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.
Clinical trial NCT07001137: Medication Reconciliation Process in Clinical Practice
Official title: Medication Reconciliation Process in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Reconciliation
Patient Safety
Geriatrics
Hospital Readmission
Pharmaceutical Services
Transitions of Care
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 386
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of elderly patients aged 75 years and older who were hospitalized in the short-stay geriatric unit of Casanova Hospital between January 1 and August 31, 2019. These patients typically present with multiple chronic conditions and are often prescribed numerous medications (polymedicated), making them particularly vulnerable to medication errors during care transitions.

The population is selected from a hospital-based, real-world clinical setting, and reflects a high-risk group for hospital readmission, emergency visits, and medication-related complications.

Brief summary: This study looks at how reviewing and confirming a patient's medications during a hospital stay can help reduce problems after they go home. It focuses on patients aged 75 and older who were admitted to a short-stay geriatric unit. The researchers compared three groups:

* Patients who did not receive any medication reconciliation (CTM),
* Patients who received CTM only at hospital admission,
* Patients who received CTM at both admission and discharge.

The goal was to see if this process could lower the number of hospital readmissions, emergency room visits, and deaths within six months after discharge. The study is based on real data from a hospital in 2019 and was conducted by pharmacists and doctors working together.


Eligibility criteria: Inclusion Criteria:

- All patients admitted to the short-stay geriatric unit of Casanova Hospital Between January 1st and August 31st, 2019

Exclusion Criteria:

- Patients who were discharged and then readmitted to the short-stay unit after a brief transfer to another unit (e.g., surgery, internal medicine, or intensive care).

Primary outcomes:
measure: Number of hospital readmissions within six months following discharge from the short-stay geriatric unit
timeFrame: Six months after discharge from the short-stay geriatric unit
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT02920437: A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
Official title: A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: dietary salt
24 hour urinary sodium excretion
blood pressure
hypertension
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot randomized controlled trial will be conducted to investigate the feasibility and effectiveness of a salt intake reduction intervention to young hypertension patients in Hong Kong who had high salt intake.

Detailed description: Convenience sample will be recruited from the community in Hong Kong through different channels of promotion.

Eligibility criteria: Inclusion Criteria:

* i) adults aged 18 to 44
* ii) diagnosed hypertension or borderline hypertension
* iii) complete collection of 24-hour urine at baseline
* iv) 24-hour urinary sodium excretion above 2000mg at baseline
* v) can communicate in Cantonese

Exclusion Criteria:

* i) renal illnesses;
* ii) taking diuretics;
* iii) taking RAS blockers;
* iv) attending or planning to attend new hypertension education programme or salt intake reduction programme during the study period.

Primary outcomes:
measure: 24-hour urinary sodium excretion
timeFrame: 10-Week
Secondary outcomes:
measure: Health literacy on low salt intake
timeFrame: 10-Week
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: School of Nursing, The University of Hong Kong
name: Chau Pui Hing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00135837: Photodynamic Therapy in Occult-Only Lesions (POOL)
Official title: An Open-Label, Multicenter, Phase 4 Study of the Effect of Verteporfin for Injection Therapy in Subjects With Occult With No Classic Choroidal NeoVascularization Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Keywords: Age related Macula Degeneration,
AMD,
choroidal neovascularisation (CNV),
occult CNV lesion,
verteporfin for injection,
photodynamic therapy (PDT)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: QLT Inc.
First posted: 2005-08-26
Enrollment: 202
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Age related macular degeneration is the leading cause of blindness for people over 50 in the western world. Blood vessels which start to grow form a lesion in the back of the eye. Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess the efficacy and safety of verteporfin in patients with occult only lesions.


Eligibility criteria: Inclusion Criteria:

* 50 years or older
* Must see better or equal to 34 letters (visual acuity)
* Choroidal neovascularization (CNV) lesion must be occult only

Exclusion Criteria:

* Evidence of classic CNV in the lesion
* Prior treatment of disease in study eye
* Have a history of moderate to severe hepatic impairment

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: visual acuity measurements, baseline, 12 months
Secondary outcomes:
measure: visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis Customer Information
role: STUDY_CHAIR
References: