louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03968328: Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Official title: The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Neutropenia
Fever
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-30
Enrollment: 315
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: Patients at the University of Texas MD Anderson Cancer Center

Brief summary: This trial uses an interview and a survey to gather information from cancer patients about the onset of their fever and the administration of antibiotics. Collecting information from patients may help doctors to assess the relationship between time to antibiotic administration and inhospital cause specific death, intensive care unit admission, hospital length of stay, and positive blood cultures.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the prognostic value of the length of time between the time onset of fever and first antibiotic administration on cause specific 14 day mortality rate.

SECONDARY OBJECTIVES:

I. To assess the associations of the length of time between the time onset of fever and first antibiotic administration with intensive care unit (ICU) admission, ICU length of stay, length of hospitalization and percentage of patients with positive blood cultures.

OUTLINE:

Patients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell.

Eligibility criteria: IInclusion criteria:

--\> 18 years of age

* Temperature above 38.0 documented
* ANC\< 500/mm3

Exclusion Criteria:

--Age \<18

Primary outcomes:
measure: 14 day cause specific mortality rate
timeFrame: At 14 days
Secondary outcomes:
measure: Cause specific death
timeFrame: Up to 5 years
measure: Intensive care unit (ICU) admission rate
timeFrame: Up to 5 years
measure: ICU length of stay
timeFrame: Up to 5 years
measure: Length of hospitalization
timeFrame: Up to 5 years
measure: Percentage of patients with positive blood cultures
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sai-ching Yeung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03574428: Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Official title: A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Temelimab
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.


Eligibility criteria: Main Inclusion Criteria:

* Healthy male volunteers
* Negative urine drug screen
* Have signed the informed consent.

Main Exclusion Criteria:

* History of serious adverse reactions or hypersensitivity to any drug.
* Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.

Primary outcomes:
measure: Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
timeFrame: 57 days
Secondary outcomes:
measure: Pharmacokinetic (PK): GNbAC1 serum concentrations over time
timeFrame: 57 days
measure: Immunogenicity: Antibodies against GNbAC1 (ADA)
timeFrame: 57 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Scientia Clinical Research Ltd
state: New South Wales
Study officials:
References:
citation: Porchet H, Vidal V, Kornmann G, Malpass S, Curtin F. A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env. Clin Ther. 2019 Sep;41(9):1737-1746. doi: 10.1016/j.clinthera.2019.05.020. Epub 2019 Jul 13.
Clinical trial NCT01259661: Physical Activity and Metabolic Risk Factors in Postmenopausal Women
Official title: Physical Activity and Metabolic Risk Factors in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Women
Keywords: physical activity
metabolic syndrome
postmenopausal women
exercise training
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.

In this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.

Results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.


Eligibility criteria: Inclusion Criteria:

* have one or more metabolic risk variables as defined by the ATP III (2001)
* age between 35 and 64 years
* absence of known heart disease
* resting BP: 130 \< SBP \< 160 and 85 \< DBP \< 100
* currently physical inactive (\< 30 min of physical activity per week)

Exclusion Criteria:

* None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.

Primary outcomes:
measure: Postmenopausal women's daily energy expenditure
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: Taipei Medical University
name: Jen-Chen Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696561: Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Official title: A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: POAG
Lead sponsor: New World Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma


Eligibility criteria: Inclusion Criteria:

1. Subjects qualifying for cataract surgery
2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.

Exclusion Criteria:

1. Patients who cannot be washed-out of IOP-lowering medications.

Primary outcomes:
measure: IOP change
timeFrame: Month6
Secondary outcomes:
measure: IOP
timeFrame: Months 6 and 12
measure: IOP meds
timeFrame: Month 6 and 12
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Clinica 20/20
city: Santa Rosa De Copán
country: Honduras
facility: Centro Oftalmologico Robles
city: Puebla
country: Mexico
facility: Laser y Ultrasonido Ocular
Study officials:
affiliation: New World Medical, Inc.
name: Mark Sun, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06757361: Effect of Screen Time Exposure on Eating Behaviour and Health Related Quality of Life
Official title: Effect of Screen Time Exposure on Eating Behaviour and Health Related Quality of Life in Normal Preschool Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Eating Behavior Disorders
Health-Related Quality of Life
Screen Time Exposure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 122
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Chronological age range 5 :6
2. Both genders will be included

Brief summary: The goal of this observational study is to learn the effect of screen time exposure on eating behaviour and health related quality of life in normal preschool children.

Detailed description: Screen media devices have become an integral to daily life, especially for preschool children due to emerging technologies, increased marketing , widespread familial and societal use , and easy access to or ownership for young children. Common screen activities include watching television, digital video discs and videos, playing video games, and using apps . However ,excessive screen time, non-educational screen content, unsupervised and early screen exposure can have numerous potential negative effects on children's health .

Screen time can significantly affect quality of life in various ways, both positively and negatively. Regarding cognitive development, screens have the potential to enhance education and learning. However, studies have shown that excessive screen time can negatively affect executive functioning, sensorimotor development, and academic outcomes. Early screen exposure has been associated with lower cognitive abilities and academic performance in later years. Language development is also affected by screen time, as it diminishes the quantity and quality of interactions between children and caregivers. Excessive screen usage can also lead to problems in social-emotional development, including obesity, sleep disturbances, depression, and anxiety. It can impair emotional comprehension, promote aggressive behavior, and hinder social and emotional competence .

Eligibility criteria: Inclusion Criteria

1. Chronological age range 5 :6
2. Both genders will be included
3. According to score of screen dependency scale children stratified into Two Groups:

   * Group A children score more than 24.5
   * Group B children score less than 24.5

Exclusion Criteria:Any children has one or more from the following criteria:

1. Any surgical intervention in mouth.
2. Any congenital anomaly in the mouth as cleft lips or cleft palate.
3. Oral disorders

Primary outcomes:
measure: Eating Behavior in Preschool Children
timeFrame: 12 weeks
measure: Health-related quality of life (HRQoL)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Faculty of physical therapy Cairo university
Study officials:
References:
Clinical trial NCT04039061: ADPKD Patient Registry
Official title: Autosomal Dominant Polycystic Kidney Disease Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Kidney Diseases
Lead sponsor: PKD Foundation
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone with ADPKD, or suspects that they have ADPKD, is welcome to participate

Brief summary: The purpose of the ADPKD Registry is to create an online patient network that includes at least 5,000 people with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who contribute data on their health and other topics. The ADPKD Patient Registry aims to support important scientific discoveries and support patient needs in the following ways:

* Connect ADPKD patients with opportunities to join clinical studies.
* Collect data for the research community to better describe the ADPKD disease experience and improve patient care.
* Engage with patients by measuring quality of life outcomes.

Detailed description: The ADPKD Registry will be a patient-powered network of people with ADPKD. This data will inform new research to improve ADPKD patient outcomes, learn more about the patient journey and discover unmet medical needs. We collect data most relevant to your ADPKD diagnosis, its major symptoms and management, as well as key demographic data (no personally identifiable information is shared). A Registry keeps information in one place making it easier for researchers to utilize Registry information while still protecting the privacy of those who take part. The Registry will be hosted on a secure, online platform that patients can access using their home computers, tablets or phones.

The purpose of the ADPKD Registry is to allow PKD patients to:

* Connect with researchers and express interest in taking part in certain clinical studies for ADPKD, including studies of new medications and other treatments.
* Take confidential health-related surveys. These surveys are aimed at better understanding of the health of people with PKD across their lifespans.

Eligibility criteria: Inclusion Criteria:

* Diagnosis or suspected diagnosis with autosomal dominant polycystic kidney disease (ADPKD)

Exclusion Criteria:

* caretakers, family members or friends of individuals with ADPKD

Primary outcomes:
measure: Number of people with polycystic kidney disease who experience health-related quality-of-life changes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: PKD Foundation
state: Missouri
Study officials:
affiliation: PKD Foundation
name: Chris Rusconi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01660061: Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
Official title: Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiphospholipid Syndrome
Keywords: Antiphospholipid syndrome
Antiphospholipid antibodies
Vitamin-K antagonists
International normalized ratio
Chromogenic factor X
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with antiphospholipid syndrome requiring long-term treatment with vitamin-K antagonists (N=40) Pateints without antiphospholipid antibodies treated with vitamin-K antagonists (N=100)

Brief summary: To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

Detailed description: Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR).

The primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X.

The second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.

Eligibility criteria: Inclusion Criteria:

* age 18-90 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Difference between INR and CFX correlate >20%
timeFrame: 0, 1, 2, 3, 6 and 12 month
Secondary outcomes:
measure: Arterial or venous thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Goethe University Hospital
state: Hessen
Study officials:
affiliation: Goethe University Hospital, Division of Vascular Medicine
name: Birgit Linnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952861: Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease
Infection
Antibiotics
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Kolding Sygehus
name: Svendborg Hospital
name: Fredericia Hospital
name: Naestved Hospital
name: Hillerod Hospital, Denmark
name: Region Syddanmark
name: Danmarks Lungeforening
name: Danish National Research Foundation
First posted: 2009-08-06
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization


Eligibility criteria: Inclusion Criteria:

* Age above 50 years
* History of smoking
* History of COPD
* Antibiotics for 24 hours
* At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
* Informed consent

Exclusion Criteria:

* Pneumonia
* Antibiotics for more than 36 hours
* Antibiotics for other infection
* Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
* Malignancy
* Other pulmonary disease
* Immune deficiency
* Not able to tolerate doxycycline
* Severe heart, liver or kidney disease
* Epilepsia
* Not stable 24 hours after hospital admission
* Need for assisted ventilation

Primary outcomes:
measure: 6 minutes walking distance
timeFrame: Day 14
Secondary outcomes:
measure: Time to next episode of acute exacerbation
timeFrame: Days 14, 30, 90 and 180
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Court Pedersen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02676661: Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease
Official title: The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Jaw, Edentulous, Partially
Keywords: peri-implant disease
risk factors
prevalence
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Partially edentulous patients implant dental implants and will be restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University

Brief summary: To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.

Detailed description: The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.

Eligibility criteria: Inclusion Criteria:

* Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.

Exclusion Criteria:

* Jaw radiotherapy treatment before and after implanting. Patients who have bruxism,xerostomia or the adjacent teeth periapical periodontitis.
* Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.
* Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.

Primary outcomes:
measure: peri-implant disease
timeFrame: at the 5 years after prosthetic loading.
Secondary outcomes:
measure: Gingival Bleeding on Probing
timeFrame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
measure: Pocket depths
timeFrame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
measure: Marginal bone loss
timeFrame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Stomatological Hospital of Fourth Military Medical University
state: Shanxi
Study officials:
affiliation: IRB of Stomatological Hospital of FMMU,PLA
name: Yongjin Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: