louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00691171: Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use
Official title: Using an Electronic Health Record-based Intervention and Broad Education Reach Strategies to Improve Quality of Care for GERD and Gastroprotection for Patients on NSAIDs: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Keywords: gastroesophageal reflux disease
GERD
nonsteroidal anti-inflammatory drugs
peptic ulcer
Diagnosed GERD
Atypical GERD symptoms
chronic NSAID therapy
Risk for ulcer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 5234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primarily primary care practices of physicians participating in the Medical Quality Improvement Consortium (MQIC)

Brief summary: The purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for upper GI tract ulcers and ulcer related complications.


Eligibility criteria: Inclusion Criteria:

* Eligibility as determined by criteria for participation in studies as part of the MQIC
* Agreement of participating clinical practices to undergo training in the electronic health record (EHR) intervention designed for this study

Exclusion Criteria:

* Based on voluntary participation by MQIC practices, so practices were excluded if they decided to opt out

Primary outcomes:
measure: Diagnoses of GERD
timeFrame: After 12 months of intervention
measure: Prescriptions for gastroprotective medicines in at-risk, chronic NSAID users
timeFrame: After 12 months of intervention
Secondary outcomes:
measure: Prescriptions for GERD medications
timeFrame: After 12 months of intervention
measure: Change in GERD symptoms score
timeFrame: After 12 months of intervention
measure: NSAID-related GI complications
timeFrame: After 12 months of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Delaware Valley Outcomes Research
name: James M Gill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gill JM, Mainous AG 3rd, Koopman RJ, Player MS, Everett CJ, Chen YX, Diamond JJ, Lieberman MI. Impact of EHR-based clinical decision support on adherence to guidelines for patients on NSAIDs: a randomized controlled trial. Ann Fam Med. 2011 Jan-Feb;9(1):22-30. doi: 10.1370/afm.1172.
Clinical trial NCT01365871: CREMS Prostate Biopsy Pain Relief Study
Official title: Pain Relief With Local Anesthetic at Time of Prostate Biopsy: Comparing Apical and Basal Injection Versus Basal Injection Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: prostate biopsy
pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2011-06-03
Enrollment: 300
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current standard for pain relief during prostate biopsy is the injection of local anesthetic agents into or around the prostate at various sites including apex, base, lateral aspects and into the prostate itself. Despite such anesthetic injection, some men still experience severe pain and often at the base of the penis. The study audits current practices comparing the degree of pain relief provided by injection at basal versus basal+apical sites. All these injection sites are standard practice at our hospital.


Eligibility criteria: Inclusion Criteria:

* Men who come for prostate biopsy

Exclusion Criteria:

* Men who are unwilling or unable to consent and fill in the forms

Primary outcomes:
measure: Pain scores comparing two groups.
timeFrame: post prostate biopsy procedure up to 6 months
Secondary outcomes:
measure: Incidence of side effects and complications.
timeFrame: post prostate biopsy procedure up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Ants Toi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04796571: Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
Official title: Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Twine Clinical Consulting LLC
First posted: 2021-03-15
Enrollment: 425
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: SUPPORTIVE_CARE

Brief summary: The study team performed a randomized controlled trial to evaluate the efficacy of a care coordination intervention composed of proactive symptom monitoring and algorithm-based triggers to improve patient reported outcomes (PROs) and healthcare expenditures for high-risk patients with IBD. Enrolled patients with IBD were randomized to proactive symptom monitoring with the support of a care coordinator or usual care.


Eligibility criteria: Inclusion Criteria:

* established diagnosis of IBD (with at least 3 office visits)
* followed in GI clinic within 1 year of enrollment
* in top 20th percentile of predicted risk for subsequent healthcare utilization (previously validated model)

Exclusion Criteria:

* non-IBD driver for high utilization (e.g., active cancer undergoing treatment
* A life expectancy of less than one year, were excluded from participation.

Primary outcomes:
measure: Change in patient reported outcome (PRO) scores
timeFrame: 9 months
measure: IBD-related charges per person
timeFrame: 12 months
measure: Total healthcare charges per person
timeFrame: 12 months
Secondary outcomes:
measure: Emergency Department (ED) visits per person
timeFrame: 12 months
measure: Proportion of hospitalizations per person
timeFrame: 12 months
measure: Change in IBD medication utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Peter Higgins, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berinstein JA, Cohen-Mekelburg SA, Greenberg GM, Wray D, Berry SK, Saini SD, Fendrick AM, Adams MA, Waljee AK, Higgins PDR. A Care Coordination Intervention Improves Symptoms But Not Charges in High-Risk Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):1029-1038.e9. doi: 10.1016/j.cgh.2021.08.034. Epub 2021 Aug 28.
Clinical trial NCT00002188: A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma
Official title: Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Sarcoma, Kaposi
Antineoplastic Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
Collaborators: name: Ligand Pharmaceuticals
First posted: 2001-08-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).

Detailed description: Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.

Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV positive status and histologic confirmation of KS.
* CD4 count \> 200 mm3 (required of one-half of patients).
* Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
* Acceptable organ system function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.

Prior Medication:

Excluded:

* Systemic therapy for KS within 30 days.
* Local or topical therapy for KS indicative lesions within 60 days.
* Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.

Required:

Approved antiretroviral therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02040688: Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder
Official title: Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SID
Feeding Disorder
SPD
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-01-20
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 7-36 months old children will be selected from:

* The clinic of feeding disorders at Dana Children's Hospital.
* The Pediatric Sleep Center at Dana Children's hospital
* Well-care clinics in the metropolitan of Tel Aviv

Brief summary: Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family.

Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from children with physiological difficulties in ingesting food, through picky eaters to full fledged infantile feeding disorders.

We have recently shown that feeding and eating difficulties are more prevalent among children with behavioral insomnia of childhood and that sleep problems are more frequent in children with feeding disorders.

We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that children with sleep or feeding disorder have increased rate of Sensory intergration disorder (SID) compared with healthy controls.


Eligibility criteria: Inclusion Criteria:

* children 7-36 months of age with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria .
* children 7-36 months of age with feeding disorders based on Chatoor criteria.
* children 7-36 months of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.

Exclusion Criteria:

Children with

* Chronic medical conditions.
* Congenital abnormalities.
* Significant developmental delay.

Primary outcomes:
measure: Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment.
timeFrame: Imidietly after the questionnaire filled by the parent.
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Pediatric Sleep Center at Dana Children's hospital
Study officials:
References:
Clinical trial NCT02781688: Increasing Physical Activity in Persons With Depression
Official title: Increasing Physical Activity in Persons With Depression - Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Physical Activity
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 25
Sex: ALL
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: TREATMENT

Brief summary: Pilot study to assess a multi-component intervention to increase physical activity in persons with depression.

Detailed description: The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among persons with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention. Intervention components will include self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 2 time points during the intervention (Weeks 7 and 13). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Positive depression screen (Patient Health Questionnaire \[PHQ-9\]) or current antidepressant treatment
* Report \<150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the Exercise Vital Sign (EVS)
* Written and verbal fluency in English

Exclusion Criteria:

* Medical condition contraindicating physical activity participation
* Cognitively unable to give informed consent
* Non-English speaking

Primary outcomes:
measure: Moderate-to-vigorous physical activity as measured by Actigraph accelerometer
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT01320488: Breast Cancer in Young Women: Is it Different?
Official title: Breast Cancer in Young Women: Is it Different?
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Female Breast Cancer
Keywords: Breast Cancer
Lead sponsor: National Guard Health Affairs
Sponsor class: OTHER_GOV
First posted: 2011-03-22
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed project is a prospective longitudinal cohort study of young women with breast cancer. Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area. It is anticipated that at least 400 of these women (from study and control group) will agree to participate in the study.

Brief summary: Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently observed at young age. The data on this observation is either lacking or scares. Furthermore, the pathological and molecular features of breast cancer in young women are not clear. The study will provide important information to the national health care planner about this disease in young women including shedding light on possible genetic risk factors

Detailed description: The study is a prospective longitudinal cohort study of young women with breast cancer. Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area. It is anticipated at least 400 of these women will agree to participate in the study. The comparable control group of older patients with breast cancer will be used for study comparison. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be surveyed every 6 months after diagnosis. The study will investigate short and long-term disease and treatment issues, and psychosocial concerns. We will also collect tumor and blood samples to characterize the pathological and molecular aspects of tumors, and establish tumor bank for future studies.

Eligibility criteria: Inclusion Criteria:

* Female
* Diagnosis of breast cancer
* Age 40 or younger at diagnosis for study group and older women for control group
* Informed consent obtained from patient

Exclusion Criteria:

* Absence of informed consent

Primary outcomes:
measure: experience of breast cancer in young women
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City for National Guard Health Affairs
Study officials:
affiliation: King Abdul Aziz Medical City for National Guard
name: Omalkahir Abulkhair, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04791488: Impact of Hyperoxia and Involvement of the Immune System in Diving Accident
Official title: Impact of Hyperoxia and Involvement of the Immune System in Diving Accident
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decompression Sickness
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. Consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness.

In mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria.

Under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells.

The results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial DNA (mtDNA), suggesting cellular destruction linked to hyperoxia/hyperbaria. In fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtDNA levels and an immune reaction through the mobilisation of leukocytes.

The main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.


Eligibility criteria: Inclusion Criteria:

* Healthy subject with no contraindications to diving OR patient admitted to the hospital for suspicion of a diving accident OR patient admitted to the hospital for hyperbaric oxygen therapy

Exclusion Criteria:

* Contraindication to diving or contraindication to hyperbaric oxygen therapy

Primary outcomes:
measure: Evolution of decompression sickness clinical symptoms
timeFrame: Until the end of the oxygen therapy treatment (up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References:
Clinical trial NCT04673188: Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
Official title: Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellar Dislocation
Keywords: Medial patello femoral ligament
Patellar instability
Reconstruction
Predicting factors
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
name: University of Ljubljana
First posted: 2020-12-17
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

Brief summary: The purpose of the study is:

1. to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity
2. to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of MPFL graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age
* surgical intervention with MPFL reconstruction
* with or without tibial tuberosity transposition (TTT).

Exclusion Criteria:

* trochleoplasty,
* corrective knee osteotomy
* reparative cartilage treatment
* reconstruction of other knee ligaments
* meniscus repair
* movement impairments
* plegia
* paresis
* neuromuscular diseases
* participation rejection
* rejection to complete the control questionnaires
* lack of understanding of the Slovenian language

Primary outcomes:
measure: Change of subjective knee status evaluated with EQ-5D
timeFrame: 2-8 years
measure: Change of subjective knee status evaluated with KOOS
timeFrame: 2-8 years
measure: Change of subjective knee status on Tegner activity scale
timeFrame: 2-8 years
measure: Change of subjective knee status evaluated with Kujala score
timeFrame: 2-8 years
measure: Change of subjective knee status on IKDC
timeFrame: 2-8 years
Secondary outcomes:
measure: Patellar position change
timeFrame: 2-8 years
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Orthopaedic Surgery of the Ljubljana University Medical Centre
Study officials:
References: