louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02369237: Non-invasive Determination of Anemia in Children With Renal Failure
Official title: A Non-invasive Device to Determine Iron Deficiency Anemia in Children of Different Age Groups With Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Lead sponsor: Center for Studies of Sensory Impairment, Aging and Metabolism
Sponsor class: OTHER
Collaborators: name: Hildegrad Grunow Foundation
name: MBR Optical Systems
First posted: 2015-02-23
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects (n ≈ 80) will be enrolled in the Fundación del Niño Enfermo Renal (FUNDANIER) in Guatemala-City. Approximately 50% of the patients in this institution are on hemodialysis and 50% are on peritoneal dialysis.

Brief summary: Anemia and inflammation are very common in patients with renal diseases. The most common procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect® is a portable device for non-invasive hemoglobin determination that works with a sensor that is applicable in infants and adults alike.

The objective of this trial is to collect spectra with the non-invasive Haemospect® device in children of different age groups with renal failure and different hemoglobin concentrations. In parallel, corresponding hemoglobin values shall be obtained invasively to form the basis for the development of an algorithm for the device.

To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are measured non-invasively with the Haemospect®. Various blood parameters for iron and inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron, white blood cell count and CRP.


Eligibility criteria: Inclusion Criteria:

* all children in treatment for renal insufficiency in FUNDANIER

Exclusion Criteria:

* none

Primary outcomes:
measure: Hemoglobin
timeFrame: 1 day
measure: Iron parameters
timeFrame: 1 day
measure: Inflammation parameters
timeFrame: 1 day
Secondary outcomes:
measure: anthropometric data
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01630837: Frequency of Oral Hygiene
Official title: Frequency of Oral Hygiene in the Maintenance of Gingival Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Oral Health
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of gingival health in patients with an adequate method of oral hygiene.

Detailed description: The study was a randomized blinded clinical trial. Eligible patients underwent a pre-clinical period in order to eliminate factors that could interfere with the proper plaque control. Forty-five non dental students with healthy gingival (maximum 5% of sites showing gingival bleeding) were randomized into four groups according to the frequency of oral hygiene (every 12h, 24h, 48h or 72h). Plaque Index (PLI) and Gingival Index (GI) were evaluated by two trained examiners at baseline, 15 days and 30 days.

Eligibility criteria: Inclusion Criteria:

* students of graduate courses at the Federal University of Santa Maria and Franciscan University Center
* a minimum age of 18 years
* filling all space interdental papilla
* at least 24 teeth
* maximum 15% of sites with gingivitis.

Exclusion Criteria:

* dental students
* pregnant woman
* diabetics
* smokers
* orthodontic equipment
* antimicrobial prophylaxis
* antibiotic
* anti-inflammatory
* psychomotor disturbances
* periodontitis
* PD ≥ 3mm

Primary outcomes:
measure: gingivitis expressed as an increase in mean gingival index in the experimental period
timeFrame: one month of evaluetion
Secondary outcomes:
measure: changes in plaque levels and variations of the average percentage of sites with different GI scores during the study
timeFrame: one month of evaluetion
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande do Sul
Study officials:
References:
citation: de Freitas GC, Pinto TM, Grellmann AP, Dutra DA, Susin C, Kantorski KZ, Moreira CH. Effect of self-performed mechanical plaque control frequency on gingival inflammation revisited: a randomized clinical trial. J Clin Periodontol. 2016 Apr;43(4):354-8. doi: 10.1111/jcpe.12520. Epub 2016 Mar 29.
citation: Pinto TM, de Freitas GC, Dutra DA, Kantorski KZ, Moreira CH. Frequency of mechanical removal of plaque as it relates to gingival inflammation: a randomized clinical trial. J Clin Periodontol. 2013 Oct;40(10):948-54. doi: 10.1111/jcpe.12135. Epub 2013 Aug 2.
Clinical trial NCT03353337: A Study of Aerobic Exercise for Patients With Bipolar Disorder
Official title: A Randomised Controlled Trial of Aerobic Exercise for Inpatients With Bipolar Affective Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Cognitive Symptom
Keywords: neurocognition
prognosis
aerobic exercise
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2017-11-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of aerobic exercise on mental states, cognition, BDNF, and long-term outcomes in patients with bipolar disorder.

Detailed description: Multiple cognitive impairments are common in patients with bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in patients with mood disorders. This randomized controlled trial will investigate short-term (1 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (12 months) effects on decreasing the recurrence rate.

Eligibility criteria: Inclusion Criteria:

* DSM-IV defined bipolar disorder.
* Never accept aerobic exercise therapy.
* dextromanuality.

Exclusion Criteria:

* Diagnosed neurological or musculoskeletal disorder/injury,
* Uncontrolled cardiovascular or metabolic diseases that are not suitable for running
* Diagnosed hypertension
* Other diagnosed serious medical conditions that are not suitable for cycling
* Severe suicidal ideation
* Mental retardation
* Currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week

Primary outcomes:
measure: Changes in neurocognitive function
timeFrame: 12 months
measure: Changes in neurocognitive function
timeFrame: Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Secondary outcomes:
measure: relapse rate
timeFrame: 12 months
measure: depressive symptoms
timeFrame: 4 weeks, 4 months, 12 months
measure: manic symptom
timeFrame: 4 weeks, 4 months, 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Brain hospital(Guangzhou Huiai Hospital)
state: Guangdong
Study officials:
affiliation: Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
name: Kangguang Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349037: Study of the Ability of a Flu Vaccine to Prevent Flu Infection
Official title: A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: DNA vaccine
influenza
immunogenicity
tolerability
PMED
efficacy
challenge virus
Lead sponsor: PowderMed
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body

Detailed description: Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for influenza as a potential alternative to existing vaccine technologies. This study will assess how effective two different PMED vaccine combinations are at preventing subjects developing influenza following exposure to flu virus 56 days after a single dose of vaccine.

Eligibility criteria: Inclusion Criteria:

Healthy adult volunteers (women must be of non child-bearing potential)

Provided written informed consent

Exclusion Criteria:

No significant concomitant illness

No allergy to gold

No immunosuppression due to disease or treatment

Pre-existing protective level of antibody against the challenge virus strain

Primary outcomes:
measure: Efficacy of the vaccine in preventing symptoms of influenza-like illness
Secondary outcomes:
measure: Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GDRU Quintiles Ltd
Study officials:
affiliation: GDRU
name: Tim Mant, BSc, FRCP, FFPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316037: Adaptation of Work in a Hospital and Assessment of Feelings of Quality of Life at Work, Teleworking and Face-to-face
Official title: Adaptation of Work in a Hospital Environment and Assessment of Feelings of Quality of Life at Work, Teleworking and Face-to-face
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Work-Related Stress
Work-Related Condition
Keywords: Teleworking
working at home
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital workers

Brief summary: The ADAPTAWORK_2 study is a follow-up to the first qualitative study, to evaluate the feelings of hospital workers in all occupations about teleworking. This involves measuring the variation between three periods: before the COVID-19 pandemic, during the first lockdown an after the pandemic.

Secondary objectives were: 1) to evaluate wich factors were associated to the feelings towards teleworking, 2) to assess musculo-squeletal disorders among teleworkers and the other participants, 3) to assess psycho-social risks among teleworkers and the oher participants, and 4) to evaluate teleworking costs

Detailed description: This is a quantitative study carried out at the Clermont-Ferrand University Hospital and in the Hospital Centers of the Homogenous Territorial Group (HTG). The target population was made up of all hospital workers in these establishments who agreed to participate and complete the online questionnaire, regardless of their function or grade in the work establishment.

Eligibility criteria: Inclusion Criteria:

* all hospital workers in the University Hospital Centre of Clermont-Ferrand, and the hospitals belonging to the same HTG who agreed to participate and complete the questionnaire, regardless of their function or grade in the work establishment

Exclusion Criteria:

N/A

Primary outcomes:
measure: Feeling about teleworking
timeFrame: Period 1 of questionnaire= from March 17, 2019 to March 17, 2020; Period 2=from March 18, 2020 to January 18, 2021; Period 3= from January 19, 2021 to January 20, 2024 (study end date).
Secondary outcomes:
measure: Musculo-squeletic pain
timeFrame: Period 3= from January 19, 2021 to January 20, 2024 (study end date).
measure: psychosocial risks
timeFrame: Period 3= from January 19, 2021 to January 20, 2024 (study end date).
measure: purchases
timeFrame: Period 1 of questionnaire= from March 17, 2019 to March 17, 2020; Period 2=from March 18, 2020 to January 18, 2021; Period 3= from January 19, 2021 to January 20, 2024 (study end date).
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Dutheil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183037: Acupuncture for Symptoms of Nerve Damage
Official title: Acupuncture for Persistent Chemotherapy-induced Peripheral Neuropathy Symptoms in Solid Tumor Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Keywords: Acupuncture
17-298
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three - arm pilot randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of real acupuncture with placebo acupuncture or usual care on symptoms of nerve damage from chemotherapy.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age ≥ 18 years old
* Solid tumor survivors with no evidence of disease
* Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale (NRS)
* Have completed neurotoxic chemotherapy at least 3 months prior to enrollment
* If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)

Exclusion Criteria:

* Patients with a pacemaker
* Prior acupuncture treatment within 5 years of enrollment

Primary outcomes:
measure: change in the proportion of patients with a CIPN severity
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ting Bao, MD, DABMA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.
Clinical trial NCT02072837: Dyslipidemia-related Risk Factors in Dialysis
Official title: Dyslipidemia-related Variables as Risk Factor for Cardiovascular Disease in Patients on the End-stage of Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Disease
Cardiovascular Disease
Dyslipidemia
Keywords: hemodialysis, dyslipidemia, cardiovascular disease
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 96
Sex: ALL
Minimum age (years): 24
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We studied 96 dialyzed patients at Nephrology Department of "Laiko, University General Hospital of Athens" and Renal Unit of "Diagnostic and Therapeutic Center of Athens Hygeia SA". 62 males and 34 females participated in this study.The treatment modalities which were applied were : regular haemodialysis (HD, n=34), predilution haemodiafiltration (HDF, n=42) and peritoneal dialysis (PD, n=20).

Brief summary: In this study, we studied lipoprotein abnormalities-related variables as risk factors for the development of cardiovascular disease in patients on renal replacement therapies.We studied 96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal replacement therapies.Dialysis adequacy was positively associated to cardioprotective HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than hemodialysis modalities.

Detailed description: Blood samples were obtained by venipuncture in the peritoneal dialyzed patients and control group in a twelve hours fasting state.In hemodialyzed patients blood was drawn just before the start of the mean weekly dialysis session also in a twelve hours fasting state from the vascular access.

All samples were received once at baseline time ( in the start of the study ). Peripheral systolic and diastolic blood pressures were calculated as an average of 10 measurements during a renal replacement treatment month in the starting time of the study.

Also, electrocardiographic examination, echocardiography and the calculation of ankle-brachial blood pressure index became once in the start of the study.

Eligibility criteria: Inclusion Criteria:

* permanent renal replacement therapy more than 6 months and
* accurate dry body weight

Exclusion Criteria:

* acute illness,
* significant infection,
* malignancy,
* Kt/V for urea \<1.2.

Primary outcomes:
measure: Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy
timeFrame: February 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National & Kapodistrian University of Athens, School of Medicine
name: Vaia D. Raikou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106337: Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid
Official title: A Multivariate Analysis of Factors Predictive of Carcinoma in Follicular Neoplasms of the Thyroid Gland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Follicular Neoplasm
Keywords: Thyroid
Follicular Neoplasms
Bethesda System
Elastography
Doppler ultrasound
Thyroidectomy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery.

Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion.

The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion.

The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy
* Patients \>18 years of age

Exclusion Criteria

* None

Primary outcomes:
measure: Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)
timeFrame: Baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Antonia E. Stephen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samir AE, Dhyani M, Anvari A, Prescott J, Halpern EF, Faquin WC, Stephen A. Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular-patterned Lesions of the Thyroid: Diagnostic Accuracy and Optimal Measurement Plane. Radiology. 2015 Nov;277(2):565-73. doi: 10.1148/radiol.2015141627. Epub 2015 May 7.