louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05571852: Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19
Official title: Before-and-after Study on the Impact of a Home-based Personalized Computerized Training Program on Cognitive Dysfunction Associated With Long COVID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Acute COVID-19
Long COVID
Keywords: Long COVID
Computerized Cognitive Training
Post-Acute Sequeale of COVID-19
Cognitive Dysfunction
Brain Fog
Lead sponsor: Universidad Antonio de Nebrija
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This before-and-after study aims to evaluate the usefulness and efficacy of a personalized computerized cognitive training (CCT) to improve cognitive function among people with post-acute sequelae of COVID-19 (PASC).

Detailed description: Through an online platform created for the study, adults who self-reported cognitive impairment more than 3 months after receiving a COVID-19 diagnosis will be enlisted and their cognitive status will be assessed using a commercially available test. After determining their level of general cognitive dysfunction, those who qualify and meet the inclusion criteria will be invited to use a customized computerized cognitive training (CCT) program at home and to complete as many daily training sessions as they would want over the course of eight weeks. The sessions will consist of gamified cognitively demanding exercises that target five cognitive skills: attention, coordination, memory, perception, and reasoning. Participants will also complete the general cognitive function assessment at the end of the intervention period, and the differences between the cognitive scores obtained before and after this period will be used as the main outcome measure. Additional analysis will be performed to better characterize the impact of the CCT by exploring the role of the age of the participants, their self-perceive health at baseline, the intensity of the training and the time from initial COVID-19 infection.

Eligibility criteria: Inclusion Criteria:

* Adults (older than 18 years old).
* History of infection with COVID-19 at least 3 months prior to expression of interest.
* Presence of self-perceived cognitive dysfunction associated with PACS (concentration problems or brain fog).

Exclusion Criteria:

* Completion of less than 10 training sessions.
* Not completing the final evaluation after the 8-week training period.

Primary outcomes:
measure: Cognitive Gains
timeFrame: 8 weeks
Secondary outcomes:
measure: Intensity of the training
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Nebrija
Study officials:
affiliation: Universidad Nebrija
name: Jon Andoni Duñabeitia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411552: Systematic Initiative to Increase Activity in Schools
Official title: Systematic Initiative to Increase Activity in Schools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Cardiovascular Fitness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Department of Public Instruction
First posted: 2015-04-08
Enrollment: 4894
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Wisconsin schools with low socio-economic status (grades 3-8)

Brief summary: This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.

Detailed description: This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness. Forty-nine schools participated in the study providing de-identified fitness data for students for 3 consecutive years. Twenty-five schools initiated physical activity interventions in year one and 24 schools initiating physical activity interventions in year two.

Eligibility criteria: Inclusion Criteria:

* all children between 3rd and 8th grade

Exclusion Criteria:

* children who could not perform PACER (exercise)

Primary outcomes:
measure: PACER fitness test
timeFrame: performed every 6 months each school year for 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Aaron L Carrel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00208052: Behavioral Indicators of Pain:Tool Development With Concurrent and Construct Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Cincinnati VA Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: PriCara, Unit of Ortho-McNeil, Inc.
First posted: 2005-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of the pilot study is to validate an assesment tool to be used in the assessment of pain in the verbal, congitively intact patient. The ultimate goal is to be able to validate this tool in the non-verbal/cognitively impaired patient.

Detailed description: Patinets will be observed for 2 six hour periods. Patients will be videotaped; every 10 minutes: EMG reading will be obtained; hourly - vital signs, pain score and saliva cortisol from "spit" will be obtained.

Eligibility criteria: Inclusion Criteria:

* In-patients with Pain diagnosis

Exclusion Criteria:

* Unable to talk and or understand basic instructions
* Under age 18 or over age 75
* Receiving pain medications regularly

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: VA Medical Center
state: Ohio
Study officials:
affiliation: VA Medical Center
name: Veronica B Steffen, MSN,RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati, College of Nursing and Health
name: Amy Pettigrew, PHD,RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753152: Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
Official title: A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-11-26
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Detailed description: Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 to 75 years of age.
2. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.

Exclusion Criteria:

1. Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
2. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.

Primary outcomes:
measure: WSRS improvement rate at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change of WSRS from Week 4, 12, 24, 36, and 52
timeFrame: Week 4, 12, 24, 36, and 52
measure: WSRS improvement rate on Week 4, 12, 36, and 52
timeFrame: Week 4, 12, 36, and 52
measure: GAIS improvement rate on Week 4, 12, 24, 36, and 52
timeFrame: Week 4, 12, 24, 36, and 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: HuaShan hospital Fudan University
Study officials:
affiliation: Huashan Hospital
name: Jinhua XU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01879852: Muscle Weakness and Post-traumatic Knee OA
Official title: Muscle Weakness and Post-traumatic Knee OA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscectomy
Keywords: Quadriceps strength
Knee
Rehabilitation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-06-18
Enrollment: 29
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.


Eligibility criteria: Inclusion Criteria:

1. traumatic onset meniscal tear (i.e. specific mechanism of injury)
2. meniscectomy surgery performed within 12 months of index injury
3. meniscal tear confirmed at the time of surgery
4. subject anticipates living in close proximity to Gainesville for one year following surgery.

Exclusion Criteria:

1. bilateral injury
2. concomitant ligamentous injury
3. previous knee injury
4. articular cartilage defect \> Grade II on Outerbridge scale
5. patellofemoral joint pain \> 3/10 with activity
6. lower limb alignment \> 5 degrees of valgus or varus
7. contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.

Primary outcomes:
measure: Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
timeFrame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
measure: Change in Tibial Articular Cartilage Volume
timeFrame: Baseline (pre-surgery) to 1 year post-surgery
Secondary outcomes:
measure: Single Leg Forward Hop Index
timeFrame: 7 weeks post-surgery (post-intervention)
measure: Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
timeFrame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF & Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Terese Chmielewski, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594952: Evaluation of Maternal Mental Health Following Ultrasonography Detection of Fetal Congenital Anomalies
Official title: Evaluation of Maternal Mental Health Following Ultrasonography Detection of Fetal Congenital Anomalies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mental Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women receiving obstetric care at our tertiary perinatal care

Brief summary: The purpose of this study is to evaluate maternal mental health during antenatal and postnatal periods after Ultrasonography diagnosis of fetal anomalies.

Detailed description: Fetal congenital anomalies are responsible for a great deal of abortions in desired pregnancies . In clinical practice, prenatal screening programs in 1st and 2nd trimester target both chromosomal and structural abnormalities. These congenital anomalies are classified as minor and major anomalies than may lead to death or stillbirth . Half of all anomalies are detectable during weeks 18-22 of pregnancy. Due to the advances occurring in Ultrasonography and screening paradigms, the rate of diagnosed anomalies is increasing dramatically which in turn leading to psychological distress in the pregnant mother. Receiving a diagnosis of fetal anomaly is a highly stressful and potentially traumatic event that can elicit immediate feelings of grief, loss, anger, depression, and anxiety. However, the foreknowledge of a fetal anomaly during pregnancy may enable the mother to prepare mentally resulting in reduced maternal stress after delivery. The American College of Medical Genetics recommends underscoring the importance of psychological assessment and substantive communication with parents facing a prenatal diagnosis of fetal anomaly. Despite the accessibility of establishing the significant symptoms of maternal psychological distress, the evidence on the definite nature of this distress in consideration to other life stressors and an accurate the prediction of women vulnerability in the critical period have not been clear yet due to many methodological issues. Identification of women at highest risk for poor adaptation to the diagnosis may allow for targeted psychological support services for those most vulnerable.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with confirmed pregnancy with viable fetus (whether singleton or multiple)
* Fetal anomaly should be diagnosed with ultrasonography (whether minor or major) after 12 weeks of gestational age

Exclusion Criteria:

- Women with history of psychiatric disorders.

Primary outcomes:
measure: Difference in anxiety scores between the study groups
timeFrame: 4 weeks
Secondary outcomes:
measure: Difference in Depression scores between the study groups
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00800852: Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome
Official title: Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Prader-Willi Syndrome
Keywords: adiponectin
adiponectin receptor
Prader-Willi syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-12-02
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Fourteen children with PWS and control subjects

Brief summary: The inflammatory process is involved in the pathogenesis of obesity. Prader-Willi syndrome (PWS) is a genetic model of syndromic obesity. Adiponectin is an adipokine with potent anti-inflammatory properties, and its effect is mediated through adiponectin receptors 1 (adipoR1) and 2 (adipoR2).

Objective of this study is to compare the expression of adipoR1, adipoR2, and adiponectin in peripheral blood mononuclear cells (PBMCs) in PWS children and obese control and to correlate receptor expression with insulin sensitivity and obesity-related parameters.


Eligibility criteria: Inclusion Criteria:

* children with Prader-willi syndrome
* children with simple obesity

Exclusion Criteria:

* subjects with diabetes mellitus (fasting plasma glucose \> 126 mg/dL with a 2-h oral glucose tolerance test value of \>200 mg/dl)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan Uiversity School of Medicine
name: Don-Kyu Jin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564252: Topical Finasteride in the Treatment of Idiopathic Hirsutism
Official title: The Efficacy of Topical Finasteride in the Treatment of Idiopathic Hirsutism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Hirsutism
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Firuzgar hospital affiliated to Iran University of Medical Sciences
First posted: 2007-11-27
Enrollment: 56
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment of idiopathic hirsutism


Eligibility criteria: Inclusion Criteria:

* Idiopathic hirsutism which is defined as normal levels of androgens and normal ovulation
* Normal serum prolactin

Exclusion Criteria:

* Pregnancy
* Simultaneous use of other drugs for the treatment of hirsutism

Primary outcomes:
measure: the efficacy of topical finasteride was determined by comparison of Ferriman-Gallwey score before and after medication
timeFrame: 6 months
Secondary outcomes:
measure: the efficacy of topical finasteride was determined by comparison of mean hair thickness before and after medication
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: endocrine and metabolism centre of Iran University of Medical Sciences
name: iraj heydari, professor assistant
role: STUDY_DIRECTOR
References:
Clinical trial NCT00280852: Review of Multimodality Management of Anaplastic Thyroid Cancer
Official title: A Retrospective Review of Multimodality Management of Anaplastic Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaplastic Thyroid Cancer
Keywords: anaplastic thyroid cancer
chemotherapy
radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anaplastic thyroid cancer

Brief summary: To describe the outcome of patients with anaplastic thyroid cancer treated with hyperfractionated radiotherapy and concomitant chemotherapy


Eligibility criteria: Inclusion Criteria:

* anaplastic thyroid cancer treated with multimodality treatment

Exclusion Criteria:

* differentiated thyroid cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Cancerboard
name: Harold Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982652: Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury
Official title: Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries
Orthostatic Hypotension
Heart Rate Variability
Keywords: Spinal Cord Injuries
Orthostatic Hypotension
Heart rate variability
Autonomic nervous system
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with SCI were recruited from a single university-affiliated rehabilitation hospital.

Brief summary: In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.

Detailed description: In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.

Eligibility criteria: Inclusion Criteria:

* spinal cord injury with or without OH
* aged 19 or older
* ASIA Impairment Scale (AIS) A to D
* neurological level of injury above T6.

Exclusion Criteria:

* Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
* Those who are taking medications affecting BP that cannot be stopped

Primary outcomes:
measure: Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)
timeFrame: at the test time (15minutes)
measure: Logistic regression analysis of heart rate variability variables according to OH and presence of symptom
timeFrame: at the test time (15minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup
state: Gyeongnam
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: PARK HAERI, Master
role: STUDY_DIRECTOR
References:
citation: Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20.
Clinical trial NCT04791852: Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy
Official title: Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Allograft Vasculopathy
Keywords: Donor-derived Cell Free DNA
Heart Transplant
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
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: Heart Transplant recipients that undergo routine surveillance coronary angiogram

Brief summary: Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who undergo routine coronary angiography \> 1 year after HT. Our main goal is to evaluate the performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 and under 80 years old, HT \> 1 year ago

Exclusion Criteria:

* Patients under 18 or over 80 years old
* Multiorgan transplant
* History of acute cellular rejection ≥ 1R or antibody mediated rejection in the previous 6 months
* Concomitant infection by CMV

Primary outcomes:
measure: Correlation between ddcf-DNA and CAV
timeFrame: 2 years
measure: Performance of the biomarker for the diagnosis of CAV
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of ddcf-DNA with the different degrees of CAV (0, 1, 2 and 3)
timeFrame: 2 years
measure: Correlation of ddcf-DNA with other biomarkers (NTproBNP and troponin I)
timeFrame: 2 years
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: University Hospital Puerta de Hierro
state: Madrid
Study officials:
References:
citation: Jimenez-Blanco Bravo M, Perez-Gomez L, Hernandez-Perez FJ, Arellano-Serrano C, Torres-Sanabria M, Gomez-Bueno M, Oteo-Dominguez JF, Mingo-Santos S, Segovia-Cubero J. Lack of Usefulness of Donor-Derived Cell-Free DNA as a Biomarker for Cardiac Allograft Vasculopathy: A Prospective Study. Front Cardiovasc Med. 2022 Apr 6;9:856600. doi: 10.3389/fcvm.2022.856600. eCollection 2022.