louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01324713: Does Gender Play a Role in Bone-mineral Density Measurement Precision?
Official title: Does Gender Play a Role in Bone-mineral Density Measurement Precision?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 90 men and 90 women volunteers who are aged 65 years and older, able and willing to provide informed consent.

Brief summary: Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the current gold standard for osteoporosis diagnosis and therapy monitoring. Like all quantitative tests, there is some variability in BMD results obtained when scanning a person more than once. As such, it is current clinical practice, based on the recommendation of the International Society for Clinical Densitometry, that each technologist perform a precision assessment. This approach consists of scanning 30 people twice; the data from which allow determination of what constitutes a real difference in BMD with 95% confidence. A precision assessment typically evaluates a specific clinic's population, using the age range and genders seen at that clinic. However men generally have larger, but often more arthritic, bones than women which may impact the precision results. Therefore, it is possible that gender-specific precision values should be used in clinical practice, however this issue has never been investigated.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Able and willing to sign informed consent

Exclusion Criteria:

* Inability to have DXA scans performed due to weight ≥ 450 pounds (exceeds densitometer table limit)
* Metallic hardware in, or overlaying, any of the measured skeletal sites

Primary outcomes:
measure: DXA Bone Mineral Density precision
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Osteoporosis Clinical Center and Research Program
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Neil Binkley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05349513: Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Official title: Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patients With Schizophrenia-like Disorders
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 56
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: OTHER

Brief summary: The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders.

Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could improve the care of this population, by making it possible to set with the patient objectives anchored in their daily life.

Detailed description: The duration of patient's participation to the study is 6 months plus 7 to 14 days.

The study includes the following visits :

* V0: Inclusion visit (Day 0) with the administration of standard of care questionnaires;
* V1: visit at patient's home (Day 0 +7 to 14 days) with the administration of the experimental ESSME questionnaire;
* V2: follow-up visit at 6 months (M6) with the administration of the same standard of care questionnaires than at the inclusion visit;
* V3: visit at patient's home (M6 + 7 to 14 days) with the administration of the experimental ESSME questionnaire.

Eligibility criteria: Inclusion Criteria:

* man or woman aged 18 to 65 inclusive;
* diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders version number 5 (DSM-V) criteria;
* patient receiving care in a Center for Rehabilitation and Intersectoral Therapeutic Activities (CREATIV);
* person who consented to the study;
* affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

* patient aged under 18 or over 65;
* pregnant or breastfeeding women;
* person unable or unwilling to receive a home visit;
* person not consenting to the study;
* presence of a diagnosis of an associated neurodevelopmental disorder;
* presence of a diagnosis of dementia or associated neurodegenerative process;
* person with a level of French language insufficient to understand the items.

Primary outcomes:
measure: Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References:
Clinical trial NCT01088113: The Relationship Between Cranial Near-InfraRed Oxygenation(NIRO) and Heart Rate Variability During Mental Exercise
Official title: The Relationship Between Cranial Near-InfraRed Oxygenation(NIRO) and Heart Rate Variability During Mental Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tai Chi Practitioner
Qigong Practitioner
Keywords: Tai Chi
Qigong
Heart rate variability
Near Infrared Spectroscopy
blood pressure
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2010-03-17
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The objective of this study is to investigate the effect of Tai Chi and Qigong practice on cranial oxyhaemoglobin level, blood pressures and autonomic nervous system responses.


Eligibility criteria: Inclusion Criteria:

* A minimal of 3 years experience on practice of either Tai Chi or Qigong

Exclusion Criteria:

* Unable to communicate or follow an exercise protocol
* Presence of cognitive impairments
* Symptomatic cardiovascular diseases
* Hypertension
* Diagnosis of stroke
* Parkinson's disease, or other neurologic disorder, peripheral neuropathy and cancer.

Primary outcomes:
measure: Level of Oxyhaemoglobin and total Haemoglobin
Secondary outcomes:
measure: Heart rate variability
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Cardiopulmonary and Exercise Physiology Laboratory, The Hong Kong Polytechnic University
state: Hong Kong
Study officials:
References:
Clinical trial NCT00848913: Strength Training After Hip Fracture Surgery
Official title: Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: strength deficit
physical function
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. The primary study hypothesis is that the training will reduce the strength deficit in the fractured limb in comparison with the non-fractured limb. Secondary, that patients following the intervention will present larger improvements in physical function compared to controls.


Eligibility criteria: Inclusion Criteria:

* Primary hip fracture surgery
* 65 years or older
* Speak and understand the Danish language
* Able to give informed consent
* Home-dwelling with and independent prefracture indoor walking ability equal to New Mobility Score \>=2

Exclusion Criteria:

* Multiple fractures
* Weightbearing restrictions
* Patient unwilling to participate in appropriate rehabilitation
* Not able to cooperate to tests
* Terminal illness
* Patients who want an observer present at the information interview, but where such one is not available.
* Patients with a cervical hip fracture treated with Total Hip Arthroplasty or hip pins, due to expected short length of hospital stay.

Primary outcomes:
measure: Knee-extension strength in the fractured limb in comparison with the non-fractured limb.
timeFrame: At inclusion, at postoperative day 10 and/or at discharge.
Secondary outcomes:
measure: Timed up and go test
timeFrame: From inclusion to postoperative day 10 and/or discharge
Other outcomes:
measure: 10 meter fast speed, Cumulated Ambulation Score.
timeFrame: At discharge and during in-hospital stay.
measure: Short Falls Efficacy Scale-International (Short FES-I)
timeFrame: At discharge
measure: Verbal Ranking Scale (VRS)
timeFrame: During in-hospital stay.
measure: 24-hour activity
timeFrame: From inclusion to discharge
Locations:
city: Hvidovre
country: Denmark
facility: Department of Orthopedic Surgery hvidovre hospital
state: Copenhagen
Study officials:
affiliation: PMR-C, Copenhagen University at Hvidovre Hospital.
name: Lise Kronborg, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Effectiveness of acute in-hospital physiotherapy with knee-extension strength training in reducing strength deficits in patients with a hip fracture: A randomised controlled trial. PLoS One. 2017 Jun 29;12(6):e0179867. doi: 10.1371/journal.pone.0179867. eCollection 2017.
Clinical trial NCT05894213: Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain
Official title: Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Chronic Lower Back Pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 164
Sex: ALL
Minimum age (years): 50
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population included 164 people aged 50 - 59 years.

Brief summary: To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain and factors associated between sarcopenia and chronic lower back pain in the pre-retirement group.


Eligibility criteria: Inclusion Criteria:

1. Be a person between the ages of 50 - 59 years with or without chronic lower back pain longer than 3 months, but without any dangerous signs of lower back pain, sciatica pain, and neurological disorder.
2. Be able to walk continuously for at least 10 minutes.
3. Give written consent to join the research project.

Exclusion Criteria:

1. Have a history of spinal fracture, spondylolisthesis, scoliosis, or osteomyelitis.
2. Have a neurological disorder or myasthenia gravis.
3. Have a congenital disease such as acute coronary syndrome, cancer, or severe muscular or joint disease that affects the ability to walk continuously for at least 10 meters.
4. Be implanted with a pacemaker or electrical device.
5. Refuse or withdraw from the study.

Primary outcomes:
measure: The prevalence of sarcopenia
timeFrame: December2019
Secondary outcomes:
measure: The associated factors 1
timeFrame: December2019
measure: The associated factors 2
timeFrame: December2019
measure: The associated factors 3
timeFrame: December2019
measure: The associated factors 4
timeFrame: December2019
measure: The associated factors 5
timeFrame: December2019
measure: The associated factors 6
timeFrame: December2019
measure: The associated factors 7
timeFrame: December2019
measure: The associated factors 8
timeFrame: December2019
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical medicine and rehabilitation
Study officials:
affiliation: Mahidol University, Ramathibodi Hospital
name: Songsuda Roongsaiwatana, MD
role: STUDY_DIRECTOR
References:
citation: Wu WT, Lee TM, Han DS, Chang KV. The Prevalence of Sarcopenia and Its Impact on Clinical Outcomes in Lumbar Degenerative Spine Disease-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Feb 15;10(4):773. doi: 10.3390/jcm10040773.
Clinical trial NCT03291236: Survival Outcomes of Uterine Cervical Malignancies in Chinese Population
Official title: Survival Outcomes of Uterine Cervical Malignancies in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Cervical Neoplasms
Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 5000
Sex: FEMALE
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 primary malignancies of uterine cervix in China.

Brief summary: This study aims to determine survival outcomes (overall survival and progression-free survival) of primary malignancies of uterine cervix in China and relevant risk factors in a prospective cohort study.


Eligibility criteria: Inclusion Criteria:

* Primary malignancies of uterine cervix.

Exclusion Criteria:

* Secondary malignancies of uternie cervix.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li L, Ma S, Tan X, Zhong S, Wu M. The Urodynamics and Survival Outcomes of Different Methods of Dissecting the Inferior Hypogastric Plexus in Laparoscopic Nerve-Sparing Radical Hysterectomy of Type C: A Randomized Controlled Study. Ann Surg Oncol. 2019 May;26(5):1560-1568. doi: 10.1245/s10434-019-07228-8. Epub 2019 Feb 13.
Clinical trial NCT03717636: Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure
Official title: Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Acute Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart failure is one of the major causes of hospitalization in Brazil and worldwide. Recent studies attempt to identify readmission and prognostic markers at the time of discharge from these patients. The reassessment and possibility of early therapeutic adjustment may be relevant in this context. Therefore, the prospective and randomized comparative use of early re-evaluation in Hospital-day versus non-intervention group has not yet been described. The objective of this study was to evaluate the impact on the re-hospitalization rate in 30 days of the early re-evaluation of the patients in the day-hospital versus the non-intervention group in heart failure. For this, a unicentric, randomized and prospective study will be performed, in which the Hospital-Day strategy is performed versus no intervention in a comparative manner. Hospital data (test results, medical outcomes, complications) of patients will be analyzed for safety and effectiveness. The hypothesis of this study is that the Hospital-Day strategy is superior to the non-intervention strategy and causes fewer rehospitalizations within 30 days.


Eligibility criteria: Inclusion Criteria:

* Adult men and women aged\> 18 years.
* Presence of decomposed CF III or IV of NYHA characterized by\> 1 symptom (dyspnea, orthopnea or edema) + 1 clinical sign (rales, edema, ascites or pulmonary congestion on chest X-ray).
* LVEF \<45% on transthoracic echocardiography.
* BNP\> 400 pg / mL.
* Clinical condition of hospital discharge.
* Signed consent form.

Exclusion Criteria:

* Pregnancy
* Body mass index greater than 40 kg / m2.
* Chronic obstructive pulmonary disease.
* Acute coronary syndrome.
* Acute myocarditis.
* Valvular heart disease.
* Need to use vasoactive drug.
* Cirrhosis of the liver Child C.
* Chronic dialysis renal insufficiency or creatinine\> 3.0 mg / dL.
* Indication of implantation device of artificial stimulation.
* Pulmonary thromboembolism.
* Neoplasm terminal.
* Sepsis or septic shock.

Primary outcomes:
measure: Comparison of 30-days rehospitalization rate
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HMFMUSP
Study officials:
affiliation: Unidade Clínica de Emergência
name: Mucio Tavares, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912236: Evaluation of High-Density Lipoprotein in Obesity Study
Official title: Evaluation of High-Density Lipoprotein in Obesity Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Obesity
HDL
HDL functionality
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from Cleveland Clinic outpatient departments

Brief summary: Obesity is associated with an impaired functioning HDL (good cholesterol) resulting in an acceleration in the development of atherosclerosis. This study will evaluate HDL functionality in patients with BMI (Body Mass Index) 20 - 25 and BMI \>30

Detailed description: This study will determine if the protective function of high-density lipoprotein (HDL) is impaired in obese patients and will help to enhance cardiovascular risk prediction. Carotid intima-media thickness (cIMT) will be captured as a means of assessing early vascular changes associated with low HDL levels in obesity. A novel measurement for clinical correlation has also been introduced called carotid extra-medial thickness (cEMT) which will be compared to cIMT in this obese population.

Eligibility criteria: Inclusion Criteria:

* Group 1:

  * Age 20-80
  * English speaking
  * BMI 20-25 kg/m2
* Group 2:

  * Age 20-80
  * English speaking
  * BMI \> 30 kg/m2
  * TG \> 150 and
  * HDL \> 50 (females) \>40 (Males)
* Group 3:

  * Age 20-80
  * English speaking
  * BMI \> 30 kg/m2
  * TG \> 150 and
  * HDL \< 50 (females) \< 40 (males)

Exclusion Criteria:

* Self-reported history of:

  * Diabetes mellitus
  * Any previous lipid therapy within the last three months
  * Macrovascular events including TIA, stroke, myocardial infarction, heart failure, claudication, or known peripheral vascular disease
  * Current pregnancy

Primary outcomes:
measure: To determine whether the functional activity of HDL is impaired in the setting of obesity
timeFrame: Within 2 weeks of enrollment
Secondary outcomes:
measure: To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry
timeFrame: Within 2 weeks of enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Stephen Nicholls, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592436: Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
Official title: A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pediatric ADHD
Keywords: ADHD
pediatric
children
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 663
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with symptoms of ADHD

Brief summary: The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies.

Detailed description: The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

Eligibility criteria: Inclusion Criteria:

1. Males and females ages 6-17
2. Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child

Exclusion Criteria:

1. History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention
2. Any significant medical condition, in the judgment of the investigator
3. Mental retardation
4. Pregnancy or lactation
5. Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence
6. Sensory difficulties such as deafness or blindness

Primary outcomes:
measure: Screening Protocol
timeFrame: Screening
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References: