louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01086137: Biomarkers of Metabolic Syndrome and Prediabetes
Official title: Assessing Salivary Biomarkers for Risk Stratification in Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Diabetes
Prediabetes
Hypertension
Keywords: salivary biomarker
metabolic syndrome
prediabetes
diabetes hypertension
Lead sponsor: West Virginia School of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to investigate the feasibility of using salivary biomarkers to screen for complications of metabolic syndrome including prediabetes.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 65 years
* Males and females will be included in this study
* All ethnic backgrounds will be included in this study
* Acceptable health based on interview and medical history
* Ability to comply with requirements of the study
* Ability and willingness to provide signed informed consent

Exclusion Criteria:

* Eating or drinking anything but water within 10 hours of sample collection
* Autoimmune disease
* Type 1 diabetes
* Pregnancy (\< 6 weeks postpartum)
* History of Sjorgren's Syndrome
* Dental work within the last two weeks
* Ongoing or active parasitic, fungal, viral or bacterial infection

Primary outcomes:
measure: Salivary Biomarker Levels
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lewisburg
country: United States
facility: West Virginia School of Osteopathic Medicine
state: West Virginia
Study officials:
affiliation: WVSOM
name: Kristie G Bridges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935337: Follow-up of a Study Examining Sleep Management in United States Veterans
Official title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management - Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Insomnia
Keywords: Sleep problems
Awareness training program
Mind body bridging
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a randomized clinical trial that compares the effects of a mind-body bridging program with a sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances. In Part II of the study, the investigators will perform a six month follow-up on the same subjects.

Detailed description: In this follow-up, we ask subjects to answer the same questionnaires that they completed at the beginning of the study. In addition we will ask subjects to complete a survey reflecting their medical history over the past 6 months and a second survey establishing their behavioral patterns and whether they continued practicing techniques of the intervention they were assigned to.

Eligibility criteria: Inclusion Criteria:

* Have participated in Part I of this study

Exclusion Criteria:

* The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.

Primary outcomes:
measure: Medical Outcomes Study-Sleep Scale
timeFrame: 6 months following study part I
measure: Medical Outcomes Study Short Form-36
timeFrame: 6 months following study part I
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: 6 months following study part I
measure: Five-factor Mindfulness Questionnaire
timeFrame: 6 months following study part I
measure: PTSD Check List-Military
timeFrame: 6 months following study part I
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: SLC VA Medical Center
state: Utah
Study officials:
affiliation: Salt Lake City VA/University of Utah
name: Gavin West, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02520037: Fluid Responsiveness Prediction Using Extra Systoles
Official title: Fluid Responsiveness Prediction Using Extra Systoles in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Keywords: Fluid responsiveness
Volume responsiveness
Hemodynamics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2015-08-11
Enrollment: 26
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: Critically ill patients admitted to a University Hospital intensive care unit

Brief summary: Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness The overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: The second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. As such, the post ectopic beat shows how the heart responds to increased filling. Therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a 500 ml volume expansion
* Patients without atrial fibrillation
* Patients equipped with ECG, arterial pressure and non-invasive cardiac output monitoring

Exclusion Criteria:

* Changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion).
* Changes in positive end-expiratory pressure the study period
* Changes in bed positioning the study period
* Infusion time with crystalloids exceeding 30 minutes
* Infusion time with colloids exceeding 75 minutes

Primary outcomes:
measure: Change in stroke volume (SV) following fluid administration. A positive fluid response is defined as a 15% or more increase in SV
timeFrame: Change in SV from immediately before fluid infusion (t=0 min) to immediately after fluid administration (t < 30 min for crystalloid infusions; t < 75 min for colloid infusions)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT03188237: AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal/Well-child Care Model in Pregnancy in Kenya
Official title: AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal and Well-child Care Model in Pregnancy in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Group, Peer
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
First posted: 2017-06-15
Enrollment: 15
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AfyaJamii is a group care model in pregnancy facilitated by Government of Kenya (GOK) Community Health Volunteers (CHVs) and Ministry of Health (MOH) nurses. Pregnant women are assigned to specific care groups according to their Expected Date of Delivery (EDD) and meet 3 times antenatally and 4 times postnatally. These groups are meant to provide women with antenatal and postnatal care, peer support, and knowledge to improve their health outcomes and the health outcomes of their infants. This model of group prenatal and postnatal care is being evaluated as an alternative to the existing policy of focused antenatal care that individualizes care to a single woman at a time.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This proposal is a program evaluation of a group care delivery model designed for pregnant women that was implemented as a pilot project in Teso District, Kenya in 2012.

Detailed description: The investigators will carry out a pre/post evaluation of this program comparing maternal and child health indicators collected at the facility and at 10 comparison facilities in the year prior to implementation (2012) and throughout the duration of the program (2013-2014). They will also analyze program attendance records, anonymous exit surveys, and training records.

Eligibility criteria: Inclusion Criteria:

* All facilities that participated in AfyaJamii

Exclusion Criteria:

* Any facility that did not offer AfyaJamii and was not been selected as a comparison facility

Primary outcomes:
measure: Facility 4 Antenatal Care (ANC) visits
timeFrame: 18 months
Secondary outcomes:
measure: Facility New Family Planning (FP)
timeFrame: 18 months
measure: Facility Total FP
timeFrame: 18 months
measure: Facility Delivery Rate
timeFrame: 18 months
measure: Facility Oral Polio Vaccine 0 (OPV0)
timeFrame: 18 months
Other outcomes:
Locations:
city: Kocholya
country: Kenya
facility: Teso North Ministry of Health Centers
Study officials:
affiliation: Moi University
name: Julia Songok, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04587037: A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear
Official title: A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Irreparable Rotator Cuff Tears
Superior Capsular Reconstruction
Fascia lata allograft
human dermal allograft
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biomechanical and clinical success of the superior capsule reconstruction (SCR) using fascia lata (FL) grafts has been reported in treating irreparable rotator cuff tear. Human dermal (HD) allograft has been used successfully for SCRs; however, the clinical comparative study between FL and HD have not been reported.


Eligibility criteria: Inclusion Criteria:

* Patients with irreparable rotator cuff tears
* Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
* At least two years follow-up

Exclusion Criteria:

* reparable rotator cuff tears
* underwent partial repair or reverse total shoulder arthroplasty

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) score
timeFrame: 2 year postoperatively
measure: Acromiohumeral distance (AHD)
timeFrame: 1 year postoperatively
measure: Retear rate
timeFrame: 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sports Medicine Service, Beijing Jishuitan hospital
name: Chunyan Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00711737: Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
Official title: Open-label Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Generalized Anxiety Disorder
Panic Disorder
Keywords: metabolic parameters
escitalopram
metabolic syndrome
antidepressant
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients in psychiatric clinic in a general hosptial

Brief summary: The purpose of this study is to explore the changes in metabolic parameters in patients treated with escitalopram for six months for major depression, generalized anxiety disorder or panic disorder, with or without agoraphobia.

Detailed description: This is an open-label study, with 4 scheduled visits. Recruitment of 100 subjects. Assessments include demographics, diagnosis, smoking frequency, Clinical Global Scale (CGI-S), weight, height,blood pressure, waist and hip circumference and fasting blood glucose and lipd profile.

Statistical analysis will be exploratory and mainly descriptive.

Eligibility criteria: Inclusion Criteria:

* Give informed consent
* Requires pharmacological treatment with escitalopram for major depression, generalized anxiety disorder or panic disorder
* Aged 21 years old and above
* Able to comprehend and comply with protocol
* Not pregnant and if of child-bearing age, using adequate methods of contraception

Exclusion Criteria:

* Currently taking or has taken in previous 3 months, any other antidepressants, antipsychotics, mood stabilizers, weight loss or lipid-profile modifying drugs
* Contraindications to escitalopram
* Unstable medical illness and/or is already under treatment of diabetes, hypertension, dyslipidemia, ischemic heart disease
* History of non-response to escitalopram
* Meets IDF definition of metabolic syndrome
* Significant risk of suicide
* Primary diagnosis or comorbid diagnosis of psychotic disorder, bipolar disorder, substance dependence and/or dementia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Lai H Peh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01101737: Trial of a Nurse Led Hypertension Clinic in Inner City General Practices
Official title: Evaluation of a Nurse-led Hypertension Clinic in Two Inner City General Practices: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension, clinical trial, nurse-led clinic, primary care
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will do a trial in two general practices to see if the introduction of a blood pressure clinic staffed by a specialist nurse supported by visiting consultant improves blood pressure control compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Patients with last recorded blood pressure greater or equal to the British Hypertension Society audit standard

Exclusion Criteria:

* Secondary hypertension
* Housebound
* Non-English speaking
* Another major illness likely to dominate pattern of care e.g. advanced cancer, dementia

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients in each group with final blood pressure below the British Hypertension Society optimal target
timeFrame: 6 months after recruitment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's, University of London
Study officials:
affiliation: St George's, University of London
name: Sally Dean, SRN
role: PRINCIPAL_INVESTIGATOR
affiliation: St George's, University of London
name: Pippa Oakeshott, MD
role: STUDY_DIRECTOR
References:
citation: Dean SC, Kerry SM, Khong TK, Kerry SR, Oakeshott P. Evaluation of a specialist nurse-led hypertension clinic with consultant backup in two inner city general practices: randomized controlled trial. Fam Pract. 2014 Apr;31(2):172-9. doi: 10.1093/fampra/cmt074. Epub 2013 Dec 19.
Clinical trial NCT03768037: Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC
Official title: A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Advanced Non-squamous NSCLC
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.

Detailed description: Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Eligibility criteria: Inclusion Criteria:

* ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
* Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
* No prior systemic treatment for non-squamous NSCLC
* Negative in EGFR\&ALK\&ROS1
* Main organs function is normal

Exclusion Criteria:

* Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
* Symptoms of brain metastases cannot be controlled and treated within less than 21 days
* Have participated in other clinical trials of anti-tumor medicine within 4 weeks
* Get any severe diseases or the ones that cannot be controlled

Primary outcomes:
measure: Proportion of patients alive and progression free at 6 months (APF6)
timeFrame: Estimated to be from baseline up to 2 years
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: Estimated to be from baseline up to 2 years
measure: Overall Survival(OS)
timeFrame: Estimated to be from baseline up to 2 years
measure: Disease Control Rate(DCR)
timeFrame: Estimated to be from baseline up to 2 years
measure: Objective Response Rate(ORR)
timeFrame: Estimated to be from baseline up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02009137: Efficacy and Safety Study of EVERA to Augment Small Breast
Official title: A Randomized-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Breast Augmentation With EVERA(Korean External Soft Tissue Expansion System) as Compared to AESTES (American External Soft Tissue Expansion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy of Breast
Keywords: small breast
augmentation
breast volume
External Soft Tissue Expansion System(ESTES)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 34
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Expected Total Number of Subjects

* Level of significance, alfa 0.05
* Power 0.80
* Mean difference between two treatments is assumed 35
* Standard Deviation is assumed 35.
* Follow-up loss is assumed 20%
* N=34(each group:17)

Detailed description: Study design

* single center, randomized, unblind clinical study Medical device
* Investigational Medical Device: EVERA
* Comparator: ESTES Process
* For eligible subjects, investigator apply Standard Deviation or Comparator on the breast
* The Investigational Medical Device is determined by randomization.
* Subjects will be applied for 12 weeks.
* Subjects will receive Patient Compliance Diary
* Subjects will visit the hospital to measure breast volume with VIVID 9i every 2 weeks for 16weeks

Eligibility criteria: Inclusion Criteria:

* Female aged between 24 and 40
* BMI of over 20
* Subjects who want to augment breasts
* Subjects who understand the study contents and signed the informed consent
* Subjects who can follow study procedure

Exclusion Criteria:

* Pregnant or Lactating subjects

Primary outcomes:
measure: The change in breast volume of the test group and control group
timeFrame: Baseline and 12weeks and 16weeks
Secondary outcomes:
measure: Changes in satisfaction level on their breast
timeFrame: Baseline and 12weeks and 16 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gumi-dong, Bundang-gu/Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chanyeong - Heo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105637: A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
Official title: A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deconditioning Among Survivors of Severe Burns
Keywords: burn injuries
exercise
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Burn injuries can affect how well you are able to perform daily activities. The reason this study is being done is to find out if aerobic exercise helps burn patients recover function, strength and stamina.

Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for strength and stamina before the start of the 12 week program, at the end of the 12 week program, as well as 6 months, 1 year and 2 years after the end of the 12 week program.

Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate.


Eligibility criteria: Inclusion Criteria:

* Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate

Exclusion Criteria:

* History of heart-related health problems
* Foot burns

Primary outcomes:
measure: Maximal Oxygen Consumption (VO2 max)
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Univeristy School of Medicine
name: Barbara J de Lateur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Lateur BJ, Magyar-Russell G, Bresnick MG, Bernier FA, Ober MS, Krabak BJ, Ware L, Hayes MP, Fauerbach JA. Augmented exercise in the treatment of deconditioning from major burn injury. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S18-23. doi: 10.1016/j.apmr.2007.09.003.