louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02660619: Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
Official title: Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-Related Disorders
Opiate Addiction
Narcotic Abuse
Drug Abuse
Lead sponsor: Member Companies of the Opioid PMR Consortium
Sponsor class: INDUSTRY
Collaborators: name: Research Foundation for Mental Hygiene, Inc.
name: Columbia University
First posted: 2016-01-21
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from low-risk and high-risk treatment settings in the greater New York City metropolitan area, which includes the five boroughs of the city and Long Island. Thus, the population will be a mix of urban and suburban participants.

Brief summary: The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.

Detailed description: "Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The present study, PMR Study #2065-2, focuses on addiction, and addresses the FDA requirement to conduct a validation study of the measure of addiction that will be used in PMR Study #2065-1.

The primary objective for Study 2b is to validate PRISM-5-Op measures of DSM-5 prescription opioid SUD/addiction in patients who have, or have had, a prescription for opioids for at least 30 days to treat chronic pain"

Eligibility criteria: Inclusion Criteria:

1. Has or has had a prescription for opioids for chronic pain for at least 30 days
2. Age 18 years or older and English-speaking
3. Willing and able to provide informed consent"

Exclusion Criteria:

1. Patient has a hearing or vision impairment that would preclude an interview or completion of self-administered questionnaires
2. Patient too cognitively impaired to give informed consent or participate in the evaluations.

Primary outcomes:
measure: Diagnoses of Addiction to Prescription Opioids via PRISM-5-Op
timeFrame: Up to 14 days (reliability determined by re-interviews 1-14 days after first interview)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Kenneth R Petronis
role: STUDY_CHAIR
References:
citation: Hasin DS, Shmulewitz D, Stohl M, Greenstein E, Aharonovich E, Petronis KR, Von Korff M, Datta S, Sonty N, Ross S, Inturrisi C, Weinberger ML, Scodes J, Wall MM. Diagnosing Prescription Opioid Use Disorder in Patients Using Prescribed Opioids for Chronic Pain. Am J Psychiatry. 2022 Oct;179(10):715-725. doi: 10.1176/appi.ajp.21070721. Epub 2022 Jun 15.
Clinical trial NCT06165419: Definitive Radiation for High-Risk Spine Metastases
Official title: A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Cancer
Metastatic Lung Cancer
Metastatic Breast Cancer
Metastatic Tumor
Metastatic Tumor of Bone
Metastatic Tumor to the Spine
Spine Metastases
Metastasis
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2023-12-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery


Eligibility criteria: Eligible patients must have:

* Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease
* Metastatic spine involvement documented by imaging
* Involvement of maximum 3 contiguous vertebral bodies at the index site
* Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids
* An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending
* ECOG Performance Status of 0-3

Patients are ineligible if they have:

* An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12
* Had previous surgery or radiation to address the target spinal metastases
* Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)

Primary outcomes:
measure: Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in epidural tumor volume
timeFrame: 3 months
measure: Changes on Neck Disability index
timeFrame: 1 months, 3 months, 6 months
measure: Changes on Oswestry Low Back Disability Questionnaire
timeFrame: 1 months, 3 months, 6 months
measure: Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
timeFrame: 1 months, 3 months, 6 months
measure: Progression-free survival
timeFrame: 6 months
measure: Overall survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook Cancer Center
name: Kartik Mani, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02998619: Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis
Official title: Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms Benign
Radiotherapy Side Effect
Lymph Node Disease
Lead sponsor: Kantonsspital Graubuenden
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective analysis of men irradiated for high risk prostate cancer including pelvic lymph nodes (L5/S1)

Brief summary: Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03.

Detailed description: Collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes.

What influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. How does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)

Eligibility criteria: Inclusion Criteria:

* Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016

Exclusion Criteria:

* Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes

Primary outcomes:
measure: Progression-free survival
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Toxicity (CTCAE v4.03)
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
Study officials:
affiliation: Kantonsspital Graubuenden
name: Daniel R Zwahlen, MD, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT05427019: Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty
Official title: Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Osteoarthritis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Continuous administration of local anesthetics to the distal adductor canal could spread into the popliteal fossa and contribute to analgesic effects on posterior knee pain. Periarticular local anesthetic infiltration is a component of multimodal joint pathways and the posterior knee capsule was among the tissues routinely infiltrated. It is expected that there will be overlapping effects of distal adductor canal block and periarticular injection. Therefore, we aim to compare the postoperative pain in the group that received only continuous distal adductor canal block and the group that received both continuous distal adductor canal block and periarticular injection. Sixty-six patients scheduled for total knee arthroplasty will be randomly divided into the two groups. In group 1, the adductor canal catheter is inserted 2cm above the adductor hiatus. In group 2, the adductor canal catheter is inserted where the nerve block performed in group 1 and periarticular injection are performed intraoperatively.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total knee arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study 2. Hepatic or renal insufficiency 3. Opioid dependency 4. Coagulopathy 5. Pre-existing neurologic or anatomic deficits in the lower extremities 6. Severe psychiatric illness

Primary outcomes:
measure: Numeric rating scale pain score
timeFrame: postoperative 1 day morning (08:00-09:00 AM)
Secondary outcomes:
measure: Numeric rating scale pain score
timeFrame: postoperative 6 hours, postoperative 1 day afternoon (4:00-5:00 PM), postoperative 2 day morning (08:00-09:00 AM)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Yong Seon Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291719: Insulin Balanced Infusion System
Official title: Insulin Balanced Infusion System Control of Glucose
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hyperglycemia
Diabetes
Keywords: closed loop glucose control
intensive care glucose control
Lead sponsor: Admetsys Corporation
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Insulin and glucose infusion in closed loop control; intervention is glucose control with insulin and glucose infusion
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery

Detailed description: The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm

Eligibility criteria: Inclusion Criteria:

* type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%
* glucose at time of study \> 150 mg/dl

Exclusion Criteria:

* pregnancy
* renal or hepatic disease
* corticosteroids
* poor intravenous access
* anemia
* electrolyte abnormality

Primary outcomes:
measure: glucose control in target range
timeFrame: data will be evaluated within 6 months after completion of all 40 studies
Secondary outcomes:
measure: hypoglycemia
timeFrame: data will be evaluated within 6 months after all 40 studies are completed
Other outcomes:
Locations:
city: Orlando
country: United States
facility: 3113 Lawton Road
state: Florida
Study officials:
affiliation: Admetsys Corporation
name: Timothy W Valk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Preliminary Study. J Diabetes Sci Technol. 2019 Sep;13(5):935-940. doi: 10.1177/1932296818821349. Epub 2019 Jan 24.
citation: Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Advancing the Development. J Diabetes Sci Technol. 2019 Sep;13(5):941-948. doi: 10.1177/1932296819832876. Epub 2019 Mar 10.
Clinical trial NCT02836119: Infant Sleep Behaviour and Gut Microbacteria
Official title: Sleep Behaviour and Gut Microbiota in Healthy Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gut Microbiota and Sleep in Infants
Keywords: Gut Microbiota
Gut Microbiome
Sleep
Infancy
Development
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Children's Hospital, Zurich
First posted: 2016-07-18
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy infants

Brief summary: The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight into the functional coevolution of the GMB and host sleep behavior.


Eligibility criteria: Inclusion Criteria:

* Good general health status
* exclusively breastfed (at baseline)
* vaginal birth delivery mode

Exclusion Criteria:

* C-section delivery mode
* Formula fed (at baseline)
* Diseases or lesions of the central nervous system, acute pediatric disease, developmental/neurologic/metabolic disorders, chronic medical conditions, or head injury
* Family history of narcolepsy/psychosis/bipolar disorder
* Conceptual age of \< 37 or \> 42 weeks
* Low birth weight (\< 2500g)
* Co-sleeping during \> 50% of the time in the same bed
* Medication use affecting sleep/alertness
* Vaccination (2 weeks prior to study)
* Antibiotics (3 months prior to study)
* Travelling across a time zone (within 1 month prior to study)
* intrauterine drug exposure, intrauterine infection, known or suspected drug or alcohol abuse
* Insufficient knowledge of German (parents)

Primary outcomes:
measure: Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)
timeFrame: across the first twelve months of life
measure: Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes
timeFrame: across the first twelve months of life
Secondary outcomes:
measure: Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)
timeFrame: across the first twelve months of life
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Clinic for Pulmonology
name: Salome Kurth, Dr. sc. nat.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01660919: Vascular and Metabolic Effects of Rosuvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: insulin resistance
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.


Eligibility criteria: Inclusion Criteria:

* hypercholesterolemia

Exclusion Criteria:

* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Primary outcomes:
measure: flow-mediated dilation
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: insulin resistance
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
Clinical trial NCT03470519: Magnesium Food Frequency Questionnaire
Official title: Validation of a Newly Developed Food Frequency Questionnaire to Assess Magnesium Intakes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women ages 20-75 years free of chronic diseases.

Brief summary: The study aims to develop a quick tool to assess magnesium intakes.

Detailed description: The study aims to develop a quick tool to assess magnesium intakes. Participants will be asked to record a complete dietary intake for 14 consecutive days, the magnesium food frequency questionnaire along with a calcium food frequency questionnaire, and a brief participant data form. Data from the 14 day consecutive food diary will be correlated with the food frequency questionnaire.

Eligibility criteria: Inclusion Criteria:

* 20-75 years of age
* Fluent in spoken and written English

Exclusion Criteria:

* Unable to report continuous food diary for 14 days
* Medical conditions/medications/supplements affecting metabolism and/or magnesium or calcium status

Primary outcomes:
measure: Magnesium Status
timeFrame: 14 days
Secondary outcomes:
measure: Calcium Status
timeFrame: 14 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Nutrition Sciences Research Lab
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03341819: Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Official title: Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Urinary Retention
Urinary Tract Infections
Epidural Anesthesia
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 242
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* History of renal disease
* History of urinary tract infection
* History of previous urinary tract surgery
* Benign prostatic hypertrophy
* Bilateral total knee arthroplasty
* Revision total knee arthroplasty
* Patients who need intraoperative monitoring of urine output

Primary outcomes:
measure: postoperative urinary retention
timeFrame: 6 hours after surgery and 6 hours after remove urinary catherter
Secondary outcomes:
measure: urinary tract infection
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiengwittayaporn S, Uthaitas P, Hongku N, Tunyasuwanakul R, Limphunudom P, Leelachiewchankul F. Indwelling urinary catheterization was unnecessary in non-drainage total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Mar;141(3):469-476. doi: 10.1007/s00402-020-03677-z. Epub 2020 Nov 12.