louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00560677: Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation(SAPPHIRE Study)
Official title: Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
PTSD
Keywords: Schizophrenia
PTSD
Cognition
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2007-11-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans with schizophrenia or schizoaffective disorder.

Brief summary: We propose to establish a database characterizing the presence or absence of comorbid PTSD in veterans with schizophrenia or schizoaffective disorder (SAD) receiving services at the Durham VA Medical Center. In addition to the evaluation of PTSD symptoms in veterans with schizophrenia or SAD, this database will facilitate the investigation of a number of additional specific research questions relevant to veterans with psychotic disorders.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

1. 18-72 years of age, any ethnic group, either sex.
2. Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder.
3. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria:

1. Unstable current medical or neurological illness.
2. Significant suicidal or homicidal ideation.
3. Pregnant women or women who could be pregnant.

Primary outcomes:
measure: Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Christine E Marx, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03288077: Nutrients to Enhance Sleep Quality and Quantity
Official title: Nutrients to Enhance Sleep Quality and Quantity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleepiness in Athletes
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2017-09-19
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Identifying non-pharmacological means of enhancing sleep is an important area of research for elite athletes. Research completed at the AIS has identified that some athletes have difficulties falling and staying asleep during both training and competition.

There are a number of dietary components such as nutrients and certain dietary supplements that are purported to decrease sleep latency and increase quality of sleep. While many of these interventions have been investigated in isolation, no research has examined different combinations and/or amounts of these substances to determine the resultant effects on sleep. The results of such a systematic investigation could produce an effective diet based sleep product ("Sleep Drink').

The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored. Additionally, the effects on sleep will be evaluated using the gold standard of sleep measurement: polysomnography.


Eligibility criteria: Inclusion Criteria:

* 18-40 year old males

Exclusion Criteria:

* Exclusion: Exclusion criteria will include any observed or disclosed injury, illness, sleep or health issue which may disrupt the subject's performance or endanger their health. Participants will need to complete an adult screening tool, as recommended by Exercise and Sports Science Australia (ESSA), to assess this.
* Blood samples will also be collected to screen for magnesium, zinc and B12 which may influence nutritional impact on sleep. If subjects score above the reference ranges for these measures, they will be excluded.
* The Pittsburg Sleep Quality Index (PSQI) and Stanford Sleepiness Scale (SSS) will be used to screen for sleep disturbances. If subjects score outside the reference ranges for these questionnaires, they will be excluded.

Primary outcomes:
measure: polysomnography
timeFrame: 0-3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AIS
name: Shona Halson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06151977: Impact of Lecuofiltration of Packed Red Blood Cells on Different Hematological Parameters Measured by Advia 2120
Official title: Impact of Lecuofiltration of Packed Red Blood Cells on Different Hematological Parameters Measured by Advia 2120
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Leucodepletion of Packed RBC
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
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: Healthy donors

Brief summary: Parameters of lecuofiltration of packed Red blood cells.

Detailed description: Impact of lecuofiltration of packed Red blood cells on different hematological parameters measured by Advia 2120

Eligibility criteria: Inclusion Criteria:

packed RBC ADIA2120

Exclusion Criteria:

* Whole blood

Primary outcomes:
measure: Impact of lecuofiltration of packed Red blood cells on different hematological parameters measured by Advia 2120
timeFrame: From 1/1/ 2024 to 29/12/2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pandey P, Pande A, Setya D, Kumar P, Shanker A. Comparative Study for Measurement of Residual Leucocytes in Leucodepleted Red Blood Cells by Two Different Methods. Indian J Hematol Blood Transfus. 2020 Oct;36(4):740-744. doi: 10.1007/s12288-020-01325-5. Epub 2020 Aug 14.
Clinical trial NCT06883877: The Effect of a Multi-modal Program on Fear of Cancer Recurrence in Breast Cancer Patients
Official title: The Effect of a Multi-modal Program on Fear of Cancer Recurrence, Breast Cancer Symptoms and Social Support in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: fear of cancer recurrence
symptoms
social support
Lead sponsor: Beijing Shijitan Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if MMP intervention can alleviate FCR , breast cancer symptoms and social support among breast cancer patients. he main questions it aims to answer are:

* Null Hypotheses (H0): There is no significant difference in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group.
* Alternative Hypotheses (H1): There are significant differences in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group

Researchers will compare MMP to a routine care to see if MMP works to alleviate FCR, breast cancer symptoms and social support.

Participants will:

* Receive interventions once per chemotherapy cycle for 8 weeks.
* The FCRI-SF, MSAS-SF-SC, and SSRS scales will be utilized to assess FCR levels, breast cancer symptoms and social support in both the experimental and control groups, with measurements conducted at baseline (T1), 8 weeks post-intervention (T2), and 12 weeks post-intervention (T3).


Eligibility criteria: Inclusion Criteria:

* Diagnosis meets the criteria outlined in the Breast Cancer Diagnosis and Treatment Guidelines, with a pathological diagnosis of breast cancer and currently undergoing chemotherapy
* Age ≥ 18 years
* Clear consciousness and the ability to communicate independently
* Aware of the diagnosis and has signed the informed consent form

Exclusion Criteria:

* Presence of mental illness or cognitive impairment
* Hearing or speech impairmen
* Distant metastasis of cance
* Severe physical illness or other malignant tumors requiring treatment

Primary outcomes:
measure: Fear of Cancer Recurrence Inventory-Short Form
timeFrame: baseline; 8 weeks post-intervention; 12 weeks post-intervention
measure: The Social Support Rating Scale
timeFrame: baseline; 8 weeks post-intervention; 12 weeks post-intervention
measure: The Chinese version of memorial symptom assessment scal
timeFrame: baseline; 8 weeks post-intervention; 12 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02203747: Patient Perception of Visual Distortions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Astigmatism
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 79
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bilaterally-implanted pseudophakic subjects over 22 years of age with astigmatism who meet the inclusion criteria.

Brief summary: The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.


Eligibility criteria: Inclusion Criteria:

* Corneal astigmatism of at least 0.75 diopters
* Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
* At least one month postoperative from second-eye surgery
* Ability to understand, read and write English to give consent and complete study questionnaire
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
* Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
* Patient is pregnant or is lactating
* Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Visual Distortion Symptoms
timeFrame: Baseline
measure: Visual Distortion Symptoms
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Contact AMO for Trial Locations
state: California
Study officials:
References:
Clinical trial NCT03900247: Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
Official title: Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: brain computer interface
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: The Danish National Rehabilitation Center for Neuromuscular Diseases
name: Bioservo Technologies AB, Sweden
name: Aarhus University Hospital
First posted: 2019-04-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current project will aid patients with motor impairment to reduce the need for homecare. Specifically the aim is to develop and implement a robotic exoskeleton and brain computer interface to assist and eventually perform arm and hand movement in patients with the progressive neurodegenerative disease ALS. This proposal brings together state-of-the-art robotic technology, EEG-based brain computer interface (BCI) know-how, clinical expertise, patient perspective and industrial partners to develop and implement a robotic arm/hand device that will adapt, with increasing brain-computer control, based on the need of the patient. In short the BCI will measure electroencephalography (EEG) from the surface of the scalp and recognize signature EEG as the patient intents to move. As the patient loses muscle power the BCI robotic-device will gradually take over and support motor activity, even when the patient is totally paralyzed. As the device supports hand/arm function only, the investigators aim to address ADLs associated to hand function, specifically eating activities.


Eligibility criteria: Inclusion Criteria:

* ALS according to the latest revision of El Escorial Criteria (Ludorph et al. 2015)
* Loss of muscle force or fine motor skills in a hand

Exclusion Criteria:

* Other severe Neurological or Psychiatric disease
* Drug or Alcohol dependency
* Pregnancy
* Severe cognitive disturbances found to impede with study completion

Primary outcomes:
measure: Action Research Armtest part b Grip
timeFrame: At 6 months
Secondary outcomes:
measure: Grip strength
timeFrame: At 6 months
measure: Bringing glass of water to the mouth
timeFrame: At 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Center of Functionally Integrative Neuroscience
Study officials:
References:
Clinical trial NCT03584347: Evaluation of Physician Volumetric Accuracy During Filler Injections
Official title: Evaluation of Physician Volumetric Accuracy During Hyaluronic Acid Soft Tissue Filler Injections and the Effect of Products' Biophysical Properties on an Injector's Performance: An Observational, Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site
Lead sponsor: Erevna Innovations Inc.
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Objectives

1. Evaluate the ability of aesthetic physicians to accurately inject a specific amount (i.e., 0.2cc) of HA soft tissue filler; and
2. Investigate the effect of different HA gel properties (e.g., G', cohesivity, viscoelasticity) on an injector's performance accuracy.


Eligibility criteria: Inclusion Criteria:

* Board-certified plastic surgeon, dermatologist, or oculoplastic surgeon.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Volumetric accuracy of HA filler injections using observational methods
timeFrame: Baseline
measure: Volumetric accuracy of HA filler expulsions over a scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Westmount
country: Canada
facility: Victoria Park Medispa
state: Quebec
Study officials:
References:
Clinical trial NCT03789747: Acute Kidney Injury After Craniotomy
Official title: Incidence and Risk Factors of Acute Kidney Injury After Craniotomy: a Single-Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidemiology
Acute Kidney Injury
Risk Factor
Keywords: incidence
prognosis
acute kidney injury
risk factor
post-craniotomy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who underwent craniocerebral operation and admitted into intensive care unit (ICU) between January 2017 and December 2018 were consecutively screened. Patients developed AKI after ICU admission were deemed as cases, and those without AKI were included in the control group.

Brief summary: The aim of this study was to investigate the incidence, risk factors and prognosis of acute kidney injury (AKI) in critically ill patients after craniotomy.

Detailed description: This was a prospective, single-center, cohort study that included adult patients who were admitted to the ICU of Beijing Tiantan Hospital from January 2017 to December 2018 after craniotomy and had a stay in the ICU for ≥ 24 hours (patients with preoperative AKI were excluded). Data collected included patient demographics (age, gender, underlying diseases, baseline serum creatinine, etc.), primary diagnosis, perioperative information, disease severity scores, as well as the occurrence of hypernatremia and hyperchloremia within 48 hours after ICU admission. For patients with AKI, pre-AKI sepsis and shock, and the recovery of renal function were recorded. All patients were followed until discharge, and information about prognosis was recorded. Multivariate regression analysis was used to identify the risk factors of AKI.

Eligibility criteria: Inclusion Criteria:

* patients underwent craniotomy
* admitted into ICU ward and the ICU length of stay ≥24h

Exclusion Criteria:

* Age\< 18 years;
* Patients with pre-existing acute kidney injury (AKI) and chronic kidney disease undergoing long-term renal replacement therapy (RRT) .

Primary outcomes:
measure: Incidence and outcome of AKI after Craniotomy
timeFrame: during hospitalization
Secondary outcomes:
measure: Risk factors for AKI after Craniotomy
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan hospital
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital
name: Jianxin Zhou, MD
role: STUDY_DIRECTOR
affiliation: Beijing Tian Tan Hospital
name: Guangzhi Shi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05085847: Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being
Official title: Molecular and Epigenetic Mechanisms Underlying Cognition Functions and Stress Response: Mindfulness-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
DNA Methylation
Learning and Memory
Stress
Psychological Well-being
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2021-10-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of a mindfulness-based intervention on DNAmethylation, cognitive functions, stress response, and well-being in healthy female adults.

Detailed description: After being informed about the study and potential risks, all volunteers giving written informed consent will undergo a 1-3 week screening period to determine eligibility for study entry. At week 0, volunteers who meet the eligibility requirements will be randomized in a 1:1 ratio to the active control group (8-week, 2 hours/week of lectures) or mindfulness-based intervention (8-week, 2 hours/week of mindfulness meditation training).

Eligibility criteria: Inclusion Criteria:

* (1) Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom

Exclusion Criteria:

1. clinical diagnosis of depression
2. clinical diagnosis of anxiety disorders
3. clinical diagnosis of schizophrenia
4. report of an infectious condition in the last 15 days before collecting a blood sample;
5. had previously practiced or currently practicing meditation, yoga or Tai-Chi.

Primary outcomes:
measure: Change from Baseline in Perceived Stress on the Perceived Stress Scale (PSS-10) at 8-weeks
timeFrame: Baseline and Post-intervention (after 8 weeks)
measure: Change from Baseline in Phycological Well-being on the Psychological Well-being Scale (SWB) at 8-weeks
timeFrame: Baseline and Post-intervention (after 8 weeks)
measure: Change from Baseline in DNA methylation at 8-weeks.
timeFrame: Baseline and Post-intervention (after 8 weeks)
measure: Change from Baseline in inflammatory cytokines at 8-weeks.
timeFrame: Baseline and Post-intervention (after 8 weeks)
measure: Change from Baseline in Cognitive function at 8-weeks.
timeFrame: Baseline and Post-intervention (after 8 weeks)
Secondary outcomes:
measure: Change from Baseline in Positive affect and negative affect at 8-weeks.
timeFrame: Baseline and Post-intervention (after 8 weeks)
measure: Change from Baseline in resilience at 8-weeks.
timeFrame: Baseline and Post-intervention (after 8 weeks)
measure: Change from Baseline in sleep quality of at 8-weeks.
timeFrame: Baseline and Post-intervention (after 8 weeks)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Daniela Rodrigues de Oliveira
Study officials:
References: