louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01680627: The Effect of Computerized Alcohol Screening and Brief Intervention (CASI) on Alcohol Consumption in Adolescent Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Consumption
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 235
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EMERGENCY DEPARTMENT

Brief summary: The purpose of this research is to examine the effectiveness of the Computerized Alcohol Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department at the UC Irvine Medical Center. This research study will evaluate the effectiveness of the brief intervention compared to standard of care (no intervention). Brief interventions have a high potential impact in ED. Computerized alcohol screening and brief intervention (CASI) is a fast and easy to use tool for patients and healthcare providers. CASI provides the Alcohol Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and CRAFFT3, followed by a brief intervention and customized alcohol intake recommendations for the patient. This study will also determine the effectiveness of the brief intervention in reducing alcohol use/abuse in adolescents between 12-17 years of age.

The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and provide an intervention at an early stage. The current data to support alcohol and screening and brief intervention in adolescents is limited. The researchers hope that this research study will add to the overall body of knowledge in support of using the emergency department as a tool in public health, as it relates to the individual patients morbidity and mortality (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor vehicle collisions).


Eligibility criteria: Inclusion Criteria:

- Ages 12-17

Exclusion Criteria:

- Intoxicated

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
References:
Clinical trial NCT00766727: Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Official title: Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Surgical Incisions From Abdominoplasty Procedures
Keywords: incision
abdominoplasty
Lead sponsor: Neodyne Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.

Detailed description: This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.

Eligibility criteria: Inclusion Criteria:

* subjects who have undergone an abdominoplasty 1 week prior to study participation

Exclusion Criteria:

* subjects with a history of collagen vascular disease or scleroderma
* subjects with known adverse reactions to steri-strips, medical tapes or adhesives

Primary outcomes:
measure: Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
timeFrame: through 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Josh Korman, MD
state: California
Study officials:
affiliation: Neodyne Biosciences, Inc.
name: Michael Longaker, MD
role: STUDY_DIRECTOR
References:
citation: Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159.
Clinical trial NCT06465927: Clinical Significance of Appendicoliths in Elderly Patients Over 80 Years Old Undergoing Emergency Appendectomy
Official title: Clinical Significance of Appendicoliths in Elderly Patients Over 80 Years Old Undergoing Emergency Appendectomy: A Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Appendicoliths in Elderly Patients
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 130
Sex: ALL
Minimum age (years): 80
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients over 80 years old who underwent emergency appendectomy for acute appendicitis at the Department of Emergency Surgery of Zhongshan Hospital, Fudan University, from January 2016 to March 2023.

Brief summary: Acute appendicitis with an appendicolith is one of the most common abdominal emergencies in elderly patients and is more likely to progress to gangrene and perforation. This study aimed to analyze the clinical data of patients over 80 years old who underwent emergency appendectomy for acute appendicitis, to explore the clinical significance of appendicoliths, and to improve treatment strategies.


Eligibility criteria: Inclusion Criteria:

* Patients who aged 80 years or older, who received conservative treatment for less than 24 hours before surgery, who had no peri-appendiceal abscess larger than 2 cm in diameter on CT scan, who underwent emergency appendectomy, and who had postoperative pathological confirmation of acute appendicitis.

Exclusion Criteria:

* Patients younger than 80 years, those with malignancies, and those with incomplete clinical or pathological records were excluded from the study.

Primary outcomes:
measure: Morbidity of elderly patients undergoing emergency appendectomy
timeFrame: January 01, 2024 to December 31, 2024.
measure: Mortality of elderly patients undergoing emergency appendectomy
timeFrame: January 01, 2024 to December 31, 2024.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03924076: Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Elementary School Children
Official title: Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Indonesian Elementary School Children: a Double Blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humoral Immune Response
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 79
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA

Detailed description: The type of the study is double blind randomize placebo-controlled trial with minimum 72 subjects which divided into 2 groups i.e. 1) placebo group which will receive UHT milk (125 mL) and 2) treatment group which will received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL). The subjects have to consume one pack of milk every day for 90 consecutive days. Before and after intervention (day 30 and day 90), several data will be collected i.e. faecal sIgA, blood IgG, IgM, and IgA. The subjects recruited from elementary school in Yogyakarta District.

Eligibility criteria: Inclusion Criteria:

* children at age of 7-9 years
* have normal body mass index (BMI) i.e. -2 ≤ z-score \< +1, slightly overweight z-score \< +1.5, and slightly underweight z-score \> -3.

Exclusion Criteria:

* allergic to milk
* consuming other probiotic product
* he/she do not want to stop consumption \& doing washout for 2 weeks.

Primary outcomes:
measure: Serum IgG
timeFrame: 90 days
measure: Serum IgA
timeFrame: 90 days
measure: Serum IgM
timeFrame: 90 days
measure: Faecal sIgA
timeFrame: 90 days
Secondary outcomes:
measure: Weight
timeFrame: 90 days
measure: Height
timeFrame: 90 days
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Universitas Gadjah Mada
state: D.I.Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: Siti Helmyati, DR.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gadjah Mada University
name: Mohammad Juffrie, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gadjah Mada University
name: Lily A Lestari, DR.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02989376: Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients
Official title: Emergent Carotid Ultrasound in Hyperacute Cerebral Vessel Occlusion for Selecting Patients to be Treated With Endovascular Clot Retrieval Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Kohnan Hospital
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 40
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: The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular imaging for selecting acute stroke patients for endovascular thrombectomy.


Eligibility criteria: Inclusion Criteria:

* Endovascular treatment can be initiated within 6 hours of symptom onset.
* ASPECTS of \>=6 is diagnosed by two or more stroke physicians.
* The end diastolic velocity in the common carotid arteries or internal carotid artery is evaluated by carotid duplex ultrasound
* NIHSS score of \>=6.
* Age\>=18 years.
* Written informed consent is obtained.

Exclusion Criteria:

* Pre-stroke modified Rankin Scale (mRS) score \>=2.
* Difficulties to evaluate ASPECTS on initial CT.
* Difficulties to groin puncture.
* History of severe allergic reaction to contrast medium.
* End stage renal disease.

Primary outcomes:
measure: modified Rankin Scale
timeFrame: at 90 days after onset
Secondary outcomes:
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Kohnan hospital
state: Miyagi
Study officials:
affiliation: Kohnan Hospital
name: Ryo Itabashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02678676: An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications
Official title: An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 3599
Sex: ALL
Minimum age (years): 36
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive study (NCT00174993) were included in this study.

Brief summary: The purpose of this study was to investigate the mortality and macrovascular morbidity as well as the incidence of malignancies over time, in high-risk diabetic participants who previously received long-term treatment with either pioglitazone or placebo in combination with their usual medication for glycaemic management.

Detailed description: This was a European,multicenter,observational study of participants who were previously treated with pioglitazone or placebo in addition to their existing anti diabetic medication. This 10-year observational study was conducted as a follow-up of PROactive study (NCT00174993) to investigate the CV and macrovascular effects observed with pioglitazone over time during PROactive.In this study,high risk T2DM patients previously enrolled in PROactive were analyzed for long-term incidence,nature, and pattern of all malignancies in pioglitazone and placebo-treated groups.This study enrolled 3599 participants.No treatment was prescribed by this protocol and participants will be managed in accordance with normal medical practice.The planned total duration of the study was 10 years,with data being analyzed and reported every 2 years.Participants were assessed at nominal visits every 6 months and every effort was made to obtain as much of the required information as possible.

Eligibility criteria: Inclusion Criteria:

* Completion of the final visit of the PROactive Study (NCT00174993).
* Willingness and ability to give written informed consent for the observational study.

Exclusion Criteria:

* There were no exclusion criteria.

Primary outcomes:
measure: Percentage of Participants With First Occurrence of Macro-vascular Event or Death
timeFrame: Up to Year 10
Secondary outcomes:
measure: Incidences With Malignancies
timeFrame: Up to Year 10
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Erdmann E, Harding S, Lam H, Perez A. Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes Metab. 2016 Mar;18(3):266-73. doi: 10.1111/dom.12608. Epub 2016 Jan 8.
Clinical trial NCT05192876: Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy
Official title: Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiotherapy; Adverse Effect
Radiotherapy; Complications
Quality of Life
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 25000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital

Brief summary: Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025

Detailed description: What are the findings of the systematic recording and analysis of the outcomes and adverse events of radiotherapy, and how do these findings improve radiotherapy for future patients?

The goals of the systematic collection and analysis of patient-related personal data include:

* Quality assurance and showing where the quality can be improved
* Recording the outcomes and side effect profile of radiotherapy and adapting to prevent serious side effects in the future
* Presentation and publication as part of the clinical research program at the Institute for Radio-Oncology of the Winterthur Cantonal Hospital

Eligibility criteria: Inclusion Criteria:

* Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital

Exclusion Criteria:

* No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital \<16 years,\> 105 years

Primary outcomes:
measure: Overall survival (OS) and progression free survival (PFS) analysis after radiation therapy
timeFrame: 25 years
measure: Analysis of risk factors influencing outcome after radiation therapy
timeFrame: 25 years
Secondary outcomes:
measure: Number of patients with acute and late adverse events after radiation therapy
timeFrame: 25 years
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Daniel Zwahlen, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02783976: Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice
Official title: A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic HCV infection living in Mexico who take SOF as part of routine clinical care at a participating clinical site.

Brief summary: This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.


Eligibility criteria: Key Inclusion Criteria:

* HCV-infected patients living in Mexico
* Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician

Key Exclusion Criteria:

* Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
* Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country prior to their SVR12 visit)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period
timeFrame: Up to Posttreatment Week 4
Secondary outcomes:
measure: Frequency of concurrent use of Sovaldi with amiodarone and another direct acting antiviral (DAA) or with potent intestinal P-gp inducers in routine clinical practice
timeFrame: Up to 24 weeks
measure: Proportion of patients with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), defined as HCV RNA < lower limit of quantification between 10 and 24 weeks post-treatment
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05560776: Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC
Official title: OPTimizing Endobronchial Ultrasound Sampling In Suspected Non Small Cell Lung Cancer for Molecular Markers : A Pragmatic Randomized Controlled TriaL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Circulating Tumor Cell
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this monocentric randomized controlled trial, 120 potential non small cell lung cancer (NSCLC) patients for which tissue diagnosis and material for next generation sequencing (NGS) is required for clinical management will be approached the day of their endobronchial ultrasound to participate in the study. They will be randomized to 2 vs 3 passes/lymph node and will all undergo liquid biopsy. The co-primary outcomes are 1)the rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node and 2)the percentage of patients for which liquid biopsy allows to identify clinically pertinent findings not available from tissue biopsy


Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed NSCLC requiring tissue sample for NGS testing to guide clinical management
* Presence of at least 2 targets accessible by EBUS or EUS suspicious of malignancy (primary tumor, lymph node \> 10mm or with Standardized Uptake Value (SUV) \> 2.5)

Exclusion Criteria:

* Other modality then EBUS judged preferable by treating physician to obtain tumoral tissue for NGS testing

Primary outcomes:
measure: Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node
timeFrame: At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing
measure: Percentage of patients for which liquid biopsy allowed to identify genetic alterations not identified from tissue biopsy
timeFrame: At 1 month
Secondary outcomes:
measure: Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/patient
timeFrame: At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing
measure: Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/sampling scheme
timeFrame: At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing
Other outcomes:
Locations:
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Marc Fortin
role: PRINCIPAL_INVESTIGATOR
References: