louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00347035: INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE
Official title: INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:

To evaluate the influence of the nonsteroidal anti-inflammatory indomethacin on the brimonidine intraocular pressure (IOP) lowering effect.

Methods:

A randomized double-masked study was carried out. Patients medicated with timolol maleate 0,5% and needed complementary medication were random allocated into two groups: (a) brimonidine tartarate 0,15% and indomethacin 1% or (b) brimonidine tartarate and placebo (balanced saline solution). If patient's both eyes were eligible, they were allocated to the same group.

IOP was measured at two weeks, one month and two months after study beginning. The mean IOP of the eyes was used for analyzes, in the case of two eligible eyes. For statistical analyzes repeated measures analysis was used.


Eligibility criteria: Inclusion Criteria:

* primary open-angle glaucoma or ocular hypertension patients with the following criteria: 18 years of age or older, insufficient response to monotherapy with timolol maleate 0,5%, and adequate compliance in follow-up treatment

Exclusion Criteria:

* hypersensitivity to eyedrop solutions, insufficient compliance in follow-up treatment, pregnancy or childbearing potential.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNIFESP/EPM Federal University of São Paulo
name: Aline K Sousa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01869335: A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
Official title: A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
MRI
mammography
microcalcifications
Local staging of breast microcalcifications
Evaluation of ex vivo MRI for breast malignancies detected by MRI only
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Radiography of breast specimens is currently the only radiological procedure used to verify removal of microcalcifications and presence of tumor-free margins after breast surgical resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not detected by radiography in resected breast tumor specimens and/or its ability to verify tumor-free margins in breast cancer detected by MRI only.


Eligibility criteria: Inclusion Criteria:

* Women with malignant breast disease identified by microcalcifications without clinically evident disease
* Women candidate to breast preserving surgery

Exclusion Criteria:

* Cardiac pacemaker, defibrillators, cardiac monitors
* Brain stimulators, implantable spinal stimulators
* Vascular and aneurismal clips
* Hemostatic clips
* Infusion pumps
* Glaucoma drainage implants
* Metallic foreign body positioned in vital organ of the patients
* Some heart valves
* Some vascular access ports, infusion pumps and catheters
* Permanent contraceptive tubal device
* Kidney disease

Primary outcomes:
measure: Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
References:
citation: Elshof LE, Rutgers EJ, Deurloo EE, Loo CE, Wesseling J, Pengel KE, Gilhuijs KG. A practical approach to manage additional lesions at preoperative breast MRI in patients eligible for breast conserving therapy: results. Breast Cancer Res Treat. 2010 Dec;124(3):707-15. doi: 10.1007/s10549-010-1064-z. Epub 2010 Jul 22.
Clinical trial NCT01134458: Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes
Official title: Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Peripheral Artery Disease
Ischemic Stroke
Diabetes
Keywords: cardiovascular disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 98
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: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose an evaluation that will assess three important components of risk communication:

1. provide patients with personalized risk communication using the risk calculator developed by FIMDM and health information taken from the Living with Coronary Artery Disease program
2. provide personalized tailored patient feedback to help initiate and maintain specific cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking cessation) to reduce their risks.
3. evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.

Detailed description: Patients at high risk for CVD events frequently underestimate their risk. Programs to improve CVD outcomes have largely focused on single risk factors and do not contextualize the information with a patient's global risk. An easy, accessible strategy to address global CVD risk based on personalized risk communication feedback with assistance with initiating and maintaining health behaviors has several advantages, but has not formally been tested. A patient's perceived risk of stroke or heart attack is an important factor in understanding motivation for risk reducing behaviors. Lower perceived risk has been associated with poorer adherence to recommended health behaviors. Additionally, a person's beliefs about his or her risk for a disease increased the likelihood of a more informed and activated patient, and figures prominently in models of health behavior (e.g., Health Belief Model). People tend to underestimate their own risk; Therefore providing accurate risk communication has the potential to activate patients to initiate and maintain behavior changes.

Eligibility criteria: Inclusion Criteria:

* cardiovascular disease (CVD)
* CVD risk equivalent (peripheral arterial disease, history of ischemic stroke, or diabetes)

Exclusion Criteria:

* metastatic cancer,
* dementia,
* active psychosis
* end-stage renal disease
* no access to computer with Internet

Primary outcomes:
measure: Cardiovascular Disease (CVD) Risk Knowledge Assessment
timeFrame: Baseline and 3 month @ study end
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Hayden Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03993158: Newborns From Patients Treated With ART (Assisted Reproductive Technology)
Official title: Prospective Cohort Study for Newborns From Patients Treated With ART in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health Related
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 10000
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns from patients treated with ART in our center.

Brief summary: The Prospective Cohort Study for Newborns from patients treated with ART was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Detailed description: Since the last twenty years, thousands of babies were born from infertile couples treated in our center. However, the short, and especially the long term prognosis of these children were barely known.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. In addition, information of each newborn from our center has also been kept in CCRM/EMRCD. The current project plans to recruit these newborn babies in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for Newborns from patients treated with ART prognosis.

Eligibility criteria: Inclusion Criteria:

* All newborns from patients treated with ART in our center.

Exclusion Criteria:

-

Primary outcomes:
measure: Birth weight
timeFrame: At delivery
measure: Number of newborns with Congenital malformations
timeFrame: At delivery
Secondary outcomes:
measure: Height development of newborns
timeFrame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
citation: Giorgione V, Parazzini F, Fesslova V, Cipriani S, Candiani M, Inversetti A, Sigismondi C, Tiberio F, Cavoretto P. Congenital heart defects in IVF/ICSI pregnancy: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jan;51(1):33-42. doi: 10.1002/uog.18932.
citation: Wagenaar K, Huisman J, Cohen-Kettenis PT, Delemarre-van de Waal HA. An overview of studies on early development, cognition, and psychosocial well-being in children born after in vitro fertilization. J Dev Behav Pediatr. 2008 Jun;29(3):219-30. doi: 10.1097/DBP.0b013e318173a575.
Clinical trial NCT03921658: The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Official title: The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-04-19
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed and/or treated for ovarian/Fallopian tube/primary peritoneal cancer by physicians in the Gynecologic Oncology Clinic at the University of Minnesota

Brief summary: Cytomegalovirus (CMV), a widely prevalent virus in the general US population, has been shown to be associated with increased inflammation and mortality. Previous small pilot studies have demonstrated that latent CMV may be reactivated during chemotherapy in cancer patients, and may be associated with unfavorable cancer outcomes such as fatigue and increased mortality.

The central research idea for this study, supported by previous preliminary data, is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer that impacts patient outcomes. The overarching goals of this observational study are:

* To assess how CMV infection is associated with ovarian cancer symptoms over the course of the disease and its treatment.
* To describe the relationship between CMV reactivation in ovarian cancer patients, survival, fatigue, and other QOL outcomes, both cross-sectionally and longitudinally.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Ability to read and write in English
* women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
* Treatment plan includes chemotherapy
* Able to provide written voluntary consent before performance of any study related procedure.
* Cohort 1 only: within 2 years of completing initial chemotherapy treatment
* Cohort 2 only: prior to starting chemotherapy

Exclusion Criteria:

* Inability to provide informed written consent
* Previous exposure to chemotherapy
* Life expectancy \< 3 months or in hospice care or nursing home

Primary outcomes:
measure: Cohort 1 - Cancer-related fatigue
timeFrame: post treatment
measure: Cohort 2 - Recurrence-free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT05713058: Metabolic Effects of Early Time-restricted Carbohydrate Consumption
Official title: Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Nutrition, Healthy
Weight Loss
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* age 18-75 years
* both males and females
* type 2 diabetes

Exclusion Criteria:

* type 1 diabetes
* insulin treatment
* pharmacological treatment for weight loss
* pregnancy
* other acute or chronic conditions influencing body weight and glucose metabolism

Primary outcomes:
measure: Glycemic control
timeFrame: 12 weeks
Secondary outcomes:
measure: Glucose tolerance
timeFrame: 12 weeks
measure: Body weight loss
timeFrame: 12 weeks
Other outcomes:
measure: Daily glucose variability
timeFrame: 14 days
measure: Beta cell function
timeFrame: 12 weeks
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: University of Pisa
name: Andrea Natali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03094858: Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
Official title: Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Risk Reduction Behavior
Keywords: Smartphone, sedentary behavior, smartphone intervention
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.


Eligibility criteria: Inclusion Criteria:

* A score of ≥ 4 on the REALM-SF85 indicating \> 6th grade English literacy level, must be at least 18 years of age
* A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall
* Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)
* Able to attend all study visits, and possess a valid home address and a functioning telephone number.

Exclusion Criteria:

* Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.

Primary outcomes:
measure: Accelerometer-measured sedentary time
timeFrame: One week
Secondary outcomes:
measure: Accelerometer-measured sedentary breaks
timeFrame: 26 weeks
measure: Accelerometer-measured total active time
timeFrame: 26 weeks
measure: Accelerometer-measured time spent in light, moderate, and vigorous activity
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Oklahoma
name: Darla Kendzor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402258: Internet-administrated Treatment of Anxiety Symptoms for Young Adults
Official title: Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2011-07-26
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 16-25 years old
* Have anxiety symptoms and/or anxiety syndrome

Exclusion Criteria:

* Suicide prone
* Alcohol addiction
* Ongoing psychological treatment

Primary outcomes:
measure: Beck Anxiety Inventory (BAI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary outcomes:
measure: Quality of Life Inventory (QOLI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: Department of Behavioral Sciences and Learning, Linköping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04527458: Case Fatalities in Hospitalised COVID-19 Patients in the UK
Official title: Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
ISARIC
Hospitalisations
Mortality
Case fatality
United Kingdom
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: International Severe Acute Respiratory and Emerging Infection Consortium
name: BREATHE Health Data Research Hub
First posted: 2020-08-26
Enrollment: 70000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with proven or high likelihood of COVID-19 admitted to the 260 UK hospitals enrolled in the ISARIC-4C study

Brief summary: This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.


Eligibility criteria: Inclusion Criteria:

* All patients admitted with a proven or high likelihood of COVID-19

Primary outcomes:
measure: Case fatality
timeFrame: 23 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
affiliation: Usher Institute, University of Edinburgh
name: Annemarie B Docherty
role: PRINCIPAL_INVESTIGATOR
affiliation: Usher Institute, University of Edinburgh
name: Ewen M Harrison
role: PRINCIPAL_INVESTIGATOR
affiliation: Usher Institute, University of Edinburgh
name: Rachel H Mulholland
role: PRINCIPAL_INVESTIGATOR
References:
citation: Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, Holden KA, Read JM, Dondelinger F, Carson G, Merson L, Lee J, Plotkin D, Sigfrid L, Halpin S, Jackson C, Gamble C, Horby PW, Nguyen-Van-Tam JS, Ho A, Russell CD, Dunning J, Openshaw PJ, Baillie JK, Semple MG; ISARIC4C investigators. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020 May 22;369:m1985. doi: 10.1136/bmj.m1985.