louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03370978: Text Messaging Follow-up From ED
Official title: The Role of Text Messaging in Follow-up Appointments for Patients Discharged From the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Text Messaging
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ensuring follow-up for patients after discharge from the emergency department (ED) has long been a concern for ED care providers. The current technology of text messaging may be able to assist us in improving follow-up rates. In addition, having a quick and easy communication tool to be in touch with providers may improve overall patient satisfaction. This study is designed to evaluate the usage of text messaging to improve follow-up appointment compliance from the Emergency Department. In this study, a prospective randomized controlled trial (RCT) will be performed (involving patients scheduled by Emergency Department Nurse Navigators to follow up with Family Medicine) in which patients will be randomized to a texting appointment reminder versus standard-of-care (no texting reminder) group. Texted patients will receive reminders 3 days and 1 day prior to their follow-up appointment. In addition, the patients will have the ability to text back-and-forth with the Nurse Navigators in order to ask questions/request clarification if needed. Chart review will be performed of both groups to evaluate the number of follow-up appointments that patients attended versus rescheduled versus did not attend/reschedule. These values will then be compared to the retrospective chart review previously performed to evaluate for non-inferiority of text messaging as a means of improving patient attendance at follow-up appointments.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old
2. Able to read, write and communicate in English - English as the primary language
3. Has a phone with capabilities for text messaging
4. Identifies oneself as someone who is comfortable with text messaging.
5. To follow-up with Family Medicine as outpatient (Scheduled through Emergency Department Nurse Navigators).
6. Evaluated in the University of Iowa Hospitals and Clinics Emergency Department

Exclusion Criteria:

1. Absence of one or more inclusion criteria
2. Not able to provide informed consent or participate due to limited decision-making ability.
3. Prisoner
4. Previously has followed with the University of Iowa Hospitals and Clinics Family Medicine (i.e., would not be a "new" patient establishing care).

Primary outcomes:
measure: Attending Primary Care Appointment
timeFrame: Less than 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
References:
Clinical trial NCT01544478: V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
Official title: A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Adenocarcinoma in Situ
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 1030
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese females
* Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
* Lifetime history of 0 to 4 male or female sexual partners
* No oral temperature ≥37.5 centigrade within 24 hours prior to injection

Exclusion Criteria:

* Received a marketed HPV vaccine
* Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
* Known history of positive test for HPV
* Known history of genital warts
* Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
* History of splenectomy, known immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)

Primary outcomes:
measure: Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
timeFrame: Up to Month 48
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Sakamoto M, Miyagi E, Sumi Y, Aisaka K, Kuno N, Nagano H, Asahara S, Han SR, Wakana A, Murata S, Sawata M, Tanaka Y. Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. J Infect Chemother. 2019 Jul;25(7):520-525. doi: 10.1016/j.jiac.2019.02.012. Epub 2019 Mar 15.
Clinical trial NCT03706378: Food Modification to Alter Glycaemia and Insulinaemia
Official title: Food Modification to Alter Glycaemia and Insulinaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Health Promotion Board, Singapore
First posted: 2018-10-16
Enrollment: 14
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study specifically aims to determine glycemic and insulinemic response of added low GI ingredients, beta-glucan, resistant starch and isomaltulose to foods.

Detailed description: There will be a total of 9 test sessions and each session will last up to 3 hours. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations. Subject will be served the test food and to consume within15 minutes. Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Eligibility criteria: Inclusion Criteria:

* Healthy Males
* Chinese ethnicity
* Age ≥21 and ≤ 40 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure ≤140/90 mmHg
* Fasting blood glucose \<6.0 mmol/L
* In general good health

Exclusion Criteria:

* Current smoker
* Have metabolic diseases (such as diabetes, hypertension etc)
* Have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* Have an ongoing infection or currently undergoing treatment at the time of screening
* Have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
* Have active Tuberculosis (TB) or currently receiving treatment for TB
* Intolerances or allergies to any foods
* Partake in sports at the competitive and/or endurance levels
* Intentionally restrict food intake

Primary outcomes:
measure: Glucose
timeFrame: up to 180 minutes
measure: Insulin
timeFrame: up to 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
Clinical trial NCT02325778: Comparison of CTI Ablation Prior to or After LA Ablation for AF
Official title: Randomized, Single-blind, Comparative Trial of Two AF Ablation Strategies (CTI Ablation Prior to LA Ablation Versus CTI After LA Ablation) to Eliminate Persistent AF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.


Eligibility criteria: Inclusion Criteria:

* continuous/persistent atrial fibrillation

Exclusion Criteria:

* age\<18
* congenital heart disease
* pacemaker or ICD implant
* previous ablation

Primary outcomes:
measure: Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm
timeFrame: Acute (intra procedure)
Secondary outcomes:
measure: Early recurrence of atrial arrhythmias
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Anthony Aizer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04678778: Virtual Reality Study - COVID-19 Protocol
Official title: Targeted Physical and Cognitive Activity in a VR Environment - COVID-19 Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Keywords: Virtual Reality
VR
Cognitive Activity
Physical Activity
Bike
Cycling
Intervention
USC
Brain Health
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overarching goal of this pilot clinical trial is to use a novel virtual reality (VR)-based intervention that simultaneously engages physical and cognitive activity aimed at improving brain and cognitive outcomes in older adults. Physical activity is a promising lifestyle intervention for mitigating cognitive decline or delaying onset of dementia. However, to fully leverage beneficial brain effects of physical activity, training the brain to learn and engage in a cognitively stimulating environment may be the key to enhanced brain and cognitive outcomes.


Eligibility criteria: Inclusion Criteria:

* 50-85 Years Old
* Able to Walk Without Assistance
* Fluent in English
* No Ferromagnetic Metal in Body
* Able to Participate in Moderate Aerobic Physical Activity

Exclusion Criteria:

* Severe Brain Injury/ Head Trauma
* Pacemakers or Metal Implants
* Claustrophobia
* Contradictions to Magnetic Resonance Imaging (MRI)/ Positron Emission Tomography (PET) Brain Scans
* Opposition to Blood Draws

Primary outcomes:
measure: Magnetic Resonance Image (MRI) brain scan of hippocampal volume (cubic mm)
timeFrame: 12 weeks
measure: Mnemonic Similarity Task for visual memory performance - discrimination index
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mark and Mary Stevens Neuroimaging and Informatics Institute of the University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Judy Pa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02421978: Inflammation-Induced CNS Glutamate During Breast Cancer Treatment
Official title: Inflammation-Induced CNS Glutamate During Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Cognitive dysfunction
Inflammation
Fatigue
Decreased motivation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-04-21
Enrollment: 98
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female breast cancer patients who are chemotherapy treated and non chemotherapy-treated and medically healthy women without breast cancer in the control group

Brief summary: The purpose of this study is to try and provide data linking the impact of increased inflammatory cytokines as a result of chemotherapy and their relationship with increased levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer patients. The investigators will use neuropsychiatric assessments, blood sampling and Magnetic Resonance Spectroscopy (MRS) to collect study data.

Detailed description: Approximately 70% of women with breast cancer experience behavioral and/or cognitive symptoms during treatment with chemotherapy and approximately 30% of women continue to experience these symptoms months to years after treatment completion. There is mounting data to suggest that inflammation may be involved and indicate that chemotherapy-treated breast cancer patients exhibit higher inflammatory markers than non-chemotherapy-treated patients, and inflammatory markers including interleukin (IL)-6 and soluble tumor necrosis factor (sTNFR2) have been associated with chemotherapy-induced depression and fatigue.

Eligibility criteria: Inclusion Criteria:

* Female breast cancer patients will have undergone surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy
* Age between 21-65 years

Exclusion Criteria:

* Taking trastuzumab

Primary outcomes:
measure: Ratio of Glutamate to Creatine
timeFrame: Baseline
measure: Levels of peripheral blood markers of inflammation
timeFrame: Baseline
measure: Cognitive dysfunction
timeFrame: Baseline
measure: Behavioral assessments
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Department of Psychiatry and Behavioral Sciences
state: Georgia
Study officials:
affiliation: Emory University
name: Andrew H Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04893278: Virtual Reality in Electrophysiology Laboratory (EP)
Official title: Use of Virtual Reality As an Adjunct for Anesthesia During Procedures in the Electrophysiology Laboratory: a Pilot and Feasibility Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: PVC - Premature Ventricular Complex
Ablation
Keywords: virtual reality
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from patients undergoing procedures under monitored anesthesia care.

Brief summary: The purpose of this study is to evaluate the use of virtual reality (VR) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (EP) procedures.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Patients scheduled for electrophysiology procedure with MAC.
* Subject willing to participate and able to provide informed consent.

Exclusion Criteria:

* Age \< 18 years old.
* History of motion sickness or blindness.

Primary outcomes:
measure: Virtual reality as distractor
timeFrame: Up to 2hours
Secondary outcomes:
measure: Impact of virtual reality use on pharmacological therapy
timeFrame: Up to 2 hours
measure: Impact of virtual reality on electrophysilogy procedure
timeFrame: Up to 2 hours
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Klaus Torp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260878: Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
Official title: Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.


Eligibility criteria: Inclusion Criteria:

1. age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \>75 years of age)
2. ability to give informed consent
3. native major papillary anatomy
4. ability and willingness to obtain bloodwork the day after ERCP

Exclusion Criteria:

1. prior ERCP with sphincterotomy and/or sphincteroplasty
2. confirmed or suspected cholangitis or sepsis
3. confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
4. NYHA Class II or greater heart failure
5. active pulmonary edema
6. myocardial infarction or ischemia within the preceding 3 months
7. renal insufficiency with CrCl \< 40 mL/minute
8. CPT Class B or C cirrhosis and/or end-stage liver disease
9. room air oxygen saturation \<90% or requirement of home O2
10. hypernatremia with Na+ ≥ 150 mEq/L or Na+ \<130 mEq/L
11. uncontrolled hypertension or hypotension
12. pregnant status

Primary outcomes:
measure: Serum amylase
timeFrame: 24 hours
Secondary outcomes:
measure: Pancreatitis
timeFrame: 7 days
measure: Bleeding
timeFrame: 30 days
measure: Cholangitis
timeFrame: 14 days
measure: Cardiorespiratory adverse event
timeFrame: 7 days
measure: Serum lipase
timeFrame: 24 hours
measure: Electrolytes
timeFrame: 24 hours
measure: Creatinine
timeFrame: 24 hours
measure: Brain natriuretic peptide
timeFrame: 24 hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
Study officials:
References:
Clinical trial NCT00854178: Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery
Official title: Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients in Good Health
Types of General Anesthesia
DNA Damage
Keywords: isoflurane
propofol
genotoxicity
gene expression
cytokines
apoptosis
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-03-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair and change cytokines profile in patients submitted to elective surgery.

Detailed description: It is expected that the results provide relevant information to understand the possible adverse effects of anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed individuals.

Eligibility criteria: Inclusion Criteria:

* patients in good health American Society of Anesthesia status physical I
* elective minor surgery
* general anesthesia

Exclusion Criteria:

* smokers
* alcoholics
* previous medication or radiation

Primary outcomes:
measure: Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile
timeFrame: within 1 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Botucatu Medical School, UNESP
state: São Paulo
Study officials:
affiliation: Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP
name: Mariana G Braz, MsC
role: PRINCIPAL_INVESTIGATOR
References: