louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00678548: Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury
Official title: Effect of Positive Guided Imagery on Patients With in or Below-level Chronic Pain Related to Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain after spinal cord injury in or below the level of injury is a common problem and can be severe.

The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury.

Detailed description: The study is a controlled simple blind randomized prospective study. Subjects who live in Trøndelag ( Norway) and who have a traumatic or non traumatic spinal cord injury with chronic pain in or below the level of injury will be included in the study.

Assessments: Pain will be measured with NRS(numeric pain rating scale) and BPIQ (Brief pain intervention questionnaire), anxiety and depression with BDI and BAI (Beck's depression and anxiety inventory) and quality of live with SF36 health survey.

The subjects will be randomized in a treatment and control group. One group will use daily for four weeks a CD with a pleasant guided imagery, the other group will write a short pain diary.

The NRS will be registered daily and the other assessments before and after the interventions.

Eligibility criteria: Inclusion Criteria:

* Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway)

Exclusion Criteria:

* Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder

Primary outcomes:
measure: Pain intensity
timeFrame: four weeks
Secondary outcomes:
measure: BDI, BAI and SF36
timeFrame: pre and postintervention
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Gunnar Leivseth, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269448: Correlation Between Peripheral and Central Venous Blood Partial Pressure of Carbon Dioxide in Critical Ill Patients
Official title: Correlation Between Peripheral and Central Venous Blood Partial Pressure of Carbon Dioxide in Critical Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Pressure of Carbon Dioxide
Keywords: partial pressure of carbon dioxide
carbon dioxide
peripheral venous blood
central venous blood
venous blood gas
blood gas analysis
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admiited to institutional ICU with central venous catheter in place

Brief summary: Observational study to analyze correlation between partial pressure of carbon dioxide from blood obtained from peripheral and central veins


Eligibility criteria: Inclusion Criteria:

* All patients admitted to institutional ICU with central venous catheter in place
* Venous blood gas analysis ordered

Exclusion Criteria:

* Central venous catheter malposition
* Difficult peripheral venous access

Primary outcomes:
measure: Difference between partial pressure of carbon dioxide
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bankok
country: Thailand
facility: Department of Anesthesiology, Ramathibodi Hospital
state: Bangkok
Study officials:
affiliation: Ramathibodi Hospital
name: Thanist Pravitharangul, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04969848: Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device
Official title: Uncontrolled, Single-center Study to Quantify Gait Disturbance in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Wearable sensor
Gait
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS patients cohort followed at Nantes university hospital

Brief summary: Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. The development of wearable device offers the opportunity to collect data during daily activity including walking.

Detailed description: Umanit and LMJ (Nantes university) has developed a device call eMSgait to assess walking ability in MS patients individuals (eg MS patients). This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue first pilot work assessing information from IGP on gait alteration in MS.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 64 years
* Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
* No relapse within the last 5 weeks before recruitment
* Able to walk with or without assistance/help/aid (one or 2 canes)
* EDSS \[0-6\]

Exclusion Criteria:

* Women who are pregnant
* Patient having expressed their opposition
* Patient under guardianship or security measure

Primary outcomes:
measure: Correlation with disability
timeFrame: One time point per patient (inclusion)
Secondary outcomes:
measure: Correlation with neurological function
timeFrame: One time point per patient (inclusion)
measure: Correlation with gait speed
timeFrame: One time point per patient (inclusion)
measure: Correlation with lateralization
timeFrame: One time point per patient (inclusion)
measure: Correlation with disability location
timeFrame: One time point per patient (inclusion)
measure: Correlation with MS symptoms severity
timeFrame: One time point per patient (inclusion)
measure: Reliability of sensor measures
timeFrame: At the inclusion
measure: Developement of dedicated algorithm to improve signal processing from IMU.
timeFrame: Day 1
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT05992948: Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis
Official title: Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transanal Stapled Anastomosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring transanal stapled anastomosis due to various reasons will be enrolled in this study.

Brief summary: Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.


Eligibility criteria: Inclusion Criteria:

Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna

* Ability and willingness to understand and comply with study interventions and restrictions.
* Voluntarily signed informed consent after full explanation of the study to the participant.

Exclusion Criteria:

* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
* Inability to communicate well with the investigator due to language problems or reduced mental development
* Inability or unwillingness to give written informed consent

Primary outcomes:
measure: EAUS
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Endoanal manometry
timeFrame: 3 months postoperative
measure: EAUS2
timeFrame: 3 months postoperative
measure: EAUS2-2
timeFrame: 12 months postoperative
measure: EAUS2-2
timeFrame: 12 months postoperative
measure: Endoanal manometry2
timeFrame: 12 months postoperative
Other outcomes:
measure: LARS Score
timeFrame: 3 months postoperative
measure: LARS Score2
timeFrame: 12 months postoperative
measure: LARS2
timeFrame: 12 months postoperative
measure: Vaizey Score
timeFrame: 3 months postoperative
measure: Vaizey Score2
timeFrame: 12 months postoperative
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01728948: Sorafenib in Elderly mRCC
Official title: Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Sorafenib
renal cell carcinoma(RCC)
elderly
effectiveness
safety
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mRCC patients, \>= 65 years of age, No prior systemic treatment, need systemic therapy

Brief summary: This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
* \>=65 years of age
* Patients who have signed the informed consent
* Patients with a life expectancy of ≥12 weeks
* No prior systemic treatment

Exclusion Criteria:

* The approved local product label must be followed for the exclusion criteria

Primary outcomes:
measure: Overall survival
timeFrame: up to 2.5 years
Secondary outcomes:
measure: Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
timeFrame: up to 2.5 years
measure: Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
timeFrame: up to 2.5 years
measure: Survival rate by one year
timeFrame: up to 1 year
measure: Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability
timeFrame: up to 3.5 years
measure: Patient characteristics (birthdate (at least year), sex, weight, height, etc)
timeFrame: up to 2.5 years
measure: Response rate (RR)
timeFrame: up to 3.5 years
measure: Time to first relief of clinical symptoms and physical signs
timeFrame: up to 3.5 years
measure: Treatment pattern
timeFrame: up to 3.5 years
Other outcomes:
Locations:
city: Many Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04435548: Westlake Gut Microbiome Study
Official title: Multi-Omic Microbiome Study: Characterization of the Human Microbiota Among Chinese Population to Understant How the Microbiome Impacts Human Health.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gut Microbiota
Lead sponsor: Westlake University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the participants should be Chinese residents, regardless of the ethics.

Brief summary: The Westlake Gut Microbiome study is a prospective cohort study. This project aims to characterize the gut microbiome among Chinese populations from different regions of China, and explore the relationships between gut microbiota and human health. Human fecal samples will be collected from the participants and muli-omics detection and analysis will be performed.

Detailed description: In the first phase of the study (also a pilot study), the investigators will create a longitudinal datasets from a students-based cohort in Westlake University. Information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations such as blood glucose, body composition and electroencephalogram will be examined, and biological samples including blood, saliva, urine and feces, will be collected.

In the second phase, the investigators will expand to include eligible participants from at least 10 provinces of China, which are located at different regions. Similar to the procedures in phase 1 stage, information about demography, life style, diet, medical history, physical activity will be recorded, clinical examinations will be performed, and biological samples will be collected.

Eligibility criteria: Inclusion Criteria:

Participants or her/his legal guardian are able to report the antibiotics use during the past 3 months; Participants or her/his legal guardian are able to understand and respond to the online questionairs; Participants or her/his legal guardian are able and willing to collect the biological samples as instructed; Participants or her/his legal guardian are able and willing to provide written informed consent; -

Exclusion Criteria:

Those with serious fundamental diseases or infectious diseases; and those with other conditions that not suitable to participate in this study, as considered by the investigators.

-

Primary outcomes:
measure: Gut microbiota
timeFrame: 36 months
measure: Metabolomics of serum and gut microbiome
timeFrame: 36 months
measure: Proteomic profiling of serum
timeFrame: 36 months
Secondary outcomes:
measure: Body composition
timeFrame: 36 months
measure: Biochemical examination of blood samples
timeFrame: 36 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109848: Observational Study of Keratoconus and Post-keratoplasty Eyes
Official title: Observational Study of Keratoconus and Post-keratoplasty Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus and Post-keratoplasty
Keywords: keratoconus
post-keratoplasty
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: National Institutes of Health (NIH)
First posted: 2014-04-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post Operative surgical patients at Oregon Health \& Science University for keratoconus, keratoplasty, DSAEK

Brief summary: A prospective observational study on keratoconus and post-keratoplasty will be conducted. We will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans will be used to measure corneal thickness (pachymetry), corneal topography (anterior and posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed for comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze formation.107, 108 In these cases PRK will be performed according to the standard of care and will not be a part of the study protocol. The postoperative results will be observed at the 3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography, ultrasound pachymetry, and Scheimpflug camera imagery


Eligibility criteria: Inclusion Criteria:

• Adults (18 \& older) with keratoconus, keratoplasty, DSAEK procedures

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* Inability to commit to required visits to complete the study.

Primary outcomes:
measure: validate OCT anterior topography
timeFrame: 3-4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Casey Eye Institute, Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT04432948: Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.
Official title: Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Maternal Psychological Distress
Anesthesia
Keywords: Covid-19
Psychological Distress
Maternal
Anaesthesia
Lead sponsor: General and Maternity Hospital of Athens Elena Venizelou
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women in labour that present into the maternity hospital from June-August 2020, during the Covid-19 pandemic

Brief summary: The aim of this study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.


Eligibility criteria: Inclusion Criteria:

* All pregnant women over the age of 18 that present in labour (vaginal delivery or caesarean section)

Exclusion Criteria:

* psychiatric disorders
* drug abuse
* not eligible to read and write in Greek

Primary outcomes:
measure: Association between Covid-19 pandemic and maternal psychological distress
timeFrame: Pre-labour assessment
Secondary outcomes:
measure: Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice
timeFrame: Pre-labour assessment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Elena Venizelou" General and Maternity Hospital of Athens
state: Attica
Study officials:
affiliation: Elena Venizelou General and Maternity Hospital of Athens, Greece
name: Georgia Micha, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.
Clinical trial NCT04981548: Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: ORIENT Study
Official title: Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: a Chinese Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasonography
Keywords: optic nerve sheath diameter
intracranial pressure
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected high intracranial pressure requiring lumbar puncture to measure spinal fluid pressure.

The normal population is healthy volunteers with matching gender and age, requiring previous physical fitness, has no history of eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma.

Brief summary: This study aims to adopt a multi-center large sample size study to define (1) the normal range of Chinese ONSD; (2) ONSD diagnosis for patients with high intracranial pressure; (3) to analyze the correlation between ONSD and intracranial pressure.

Detailed description: The ONSD, transcranial Doppler parameters and baseline data of the normal intracranial pressure group and the enhanced intracranial pressure group (more than 200 mmH2O) .

Eligibility criteria: Inclusion Criteria:

1. People requiring lumbar puncture testing due to brain trauma, intracranial infection, intracranial vascular disease, intracranial tumors, peripheral neuropathy for the raised intracranial pressure group.
2. Healthy people for the normal intracranial pressure group.

Exclusion Criteria:

1. eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma
2. People with poor temporal window penetration.
3. Patients who refuse to sign informed consent.

Primary outcomes:
measure: The normal range of ONSD in healthy Chinese adults.
timeFrame: 2021.8-2022.8
measure: determine the ONSD cut-off point for high intracranial pressure.
timeFrame: 2021.8-2022.8
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: the first hospital of Jilin university
state: Jilin
Study officials:
References:
citation: Wang LJ, Chen LM, Chen Y, Bao LY, Zheng NN, Wang YZ, Xing YQ. Ultrasonography Assessments of Optic Nerve Sheath Diameter as a Noninvasive and Dynamic Method of Detecting Changes in Intracranial Pressure. JAMA Ophthalmol. 2018 Mar 1;136(3):250-256. doi: 10.1001/jamaophthalmol.2017.6560.