louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03577353: Dual-task Training Using Virtual Reality
Official title: Dual-task Training Using Virtual Reality: Influence on Walking and Balance in Post Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors


Eligibility criteria: Inclusion Criteria:

* With hemiplegia after a stroke for at least a year since the incident.
* Range age 40-80.
* Without medication or with stabilized medication.
* Use ankle-foot orthosis or no splint at all.

Exclusion Criteria:

* Severe cardiac problems
* A score less than 25 in the Mini-Mental test.
* Fractures or severe orthopedic limitations that do not allow for training, and which have occurred over the last six months.
* More than three falls in the past year before participating in the study

Primary outcomes:
measure: change in 10-meter walking test across pre, post and follow-up time points.
timeFrame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
measure: Change in Timed up and go across pre, post and follow-up time points.
timeFrame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
measure: Change in Functional Reach Test across pre, post and follow-up time points.
timeFrame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
measure: Change in Activities-specific Balance Confidence (ABC) Scale
timeFrame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
measure: Change in The Berg Balance Scale (BBS) across pre, post and follow-up time points.
timeFrame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: The Academic College at Wingate
Study officials:
affiliation: Graduate School Academic College at Wingate
name: Yeshayahu Hutzler, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00901953: Vestibular System in Migrainous Vertigo Patients
Official title: Do Migrainous Vertigo Patients Have More Hypersensitivity in Their Vestibular System Than Migraine Patients Without Vertigo?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine Disorders
Migraine Variant
Episodic Recurrent Vertigo
Keywords: migraine
migrainous vertigo
vestibular evoked myogenic potentials
vestibular function test
vestibular disorders
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
First posted: 2009-05-14
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine patients: primary care clinic

Migrainous vertigo patients: Neurological outpatients clinic, Sorlandet Hospital HF, Kristiansand and Spesialistsenteret, Tollbodgata 4, Kristiansand.

Brief summary: Do migrainous vertigo patients have more pathology in their vestibular system than migraine patients without vertigo?

The aim of this study is to compare the vestibular system of migraine patients with and without vertigo in the symptom-free period by vestibular function tests, videonystagmography, vestibular evoked myogenic potentials, and subjective visual vertical.


Eligibility criteria: Inclusion Criteria:

* migraine according to IHS criteria
* migrainous vertigo according to the Neuhauser-criteria

Exclusion Criteria:

* no history of other neurological, vestibular, opthalmologic and ENT disorders
* no medications that could possibly influence test results
* intact hearing measured by audiometry
* pregnancy

Primary outcomes:
measure: Differences in vestibular function
timeFrame: Symptomfree interval
Secondary outcomes:
measure: Differences in hypersensitivity
timeFrame: Symptomfree interval
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Dept. of neurology, Sørlandet Hospital HF
Study officials:
affiliation: Institute of clinical medicine, university of Bergen, Norway
name: Åse Mygland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120453: Interplay of Self-Criticism and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment
Official title: Assessment of the Interplay Between Self-critisim and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self-Criticism
Psychological Distress
In-Patient Treatment
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 2778
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients undergoing in-patient treatment at the university clinic Heidelberg. The psychosomatic clinic treats patients over the course of (usually) 8 weeks.

Brief summary: The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment.

Detailed description: Participants are recruited at the University Clinic Heidelberg at the beginning of their (usually) 8-week in-patient treatment, consisting of somatic and psychotherapeutic aspects. After informed consent, patients routinely fill out weekly questionnaires about their self-criticism and their symptom severity. The overall aim of this study is to disentangle stable (between-person) effects of both self-criticism and symptom severity from within-person effects happening over time in order to better understand what drives what, or in other words, their dynamic interplay. The analysis is based on the weekly assessment of the patients. All patients receive the standard care of the in-patient treatment.

Eligibility criteria: Inclusion Criteria:

* Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik)

Exclusion Criteria:

* none

Primary outcomes:
measure: SCL-K11
timeFrame: Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)
measure: TDEQ-12 (Subscale Self-Criticism
timeFrame: Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Heidelberg
name: Ulrike Dinger, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01709253: Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
Official title: Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Adenocarcinoma
Keywords: hpofractionation study using proton beam therapy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-10-18
Enrollment: 117
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma


Eligibility criteria: Inclusion Criteria:

Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry

Exclusion Criteria:

Postoperative residual or recurrent tumor Evidence of distant metastases Previous irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)

Primary outcomes:
measure: clinical outcomes
timeFrame: up to 5years from a initial follow-up
Secondary outcomes:
measure: acute toxicity
timeFrame: up to 5years from a initial follow-up
measure: late toxicity
timeFrame: up to 5years from a initial follow-up
measure: overall survival
timeFrame: up to 5years from a initial follow-up
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National cancer center, korea
state: Gyeonggi-do,
Study officials:
affiliation: National Cancer Center, Korea
name: kwan ho cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ha B, Cho KH, Lee KH, Joung JY, Kim YJ, Lee SU, Kim H, Suh YG, Moon SH, Lim YK, Jeong JH, Kim H, Park WS, Kim SH. Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation. Radiat Oncol. 2019 Jan 10;14(1):4. doi: 10.1186/s13014-019-1210-7.
Clinical trial NCT00137553: The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
Official title: The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria, Falciparum
Keywords: Children
malaria
sulfadoxine-pyrimethamine
Guinea-Bissau
treatment
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for the treatment of malaria will, if getting malaria during follow-up, be re-treated with sulfadoxine-pyrimethamine (SP) in accordance with the recommendations of the National Malaria Programme.

To compare the actual efficacy of SP with that in 1995 - 1996 we, the investigators of the Bandim Health Project, will visit these children once a week for 5 weeks. A finger prick blood sample will be collected for a malaria test.

Children with malaria during follow-up will be treated according to the guidelines of the Bandim Health Centre.

Detailed description: The Bandim Health Project studies the efficacy of different treatment regimens for malaria in children. If the included children during follow-up get malaria again they are, according to the recommendations of the National Malaria Programme, treated with sulfadoxine-pyrimethamine (SP).

In 1995 - 1996 the efficacy of this re-treatment regimen was evaluated in the same area.

To evaluate if treatment with SP is still efficient we want to follow children included in a study comparing treatment with chloroquine and amodiaquine having recrudescent malaria for 35 days following the re-treatment with SP.

Children with reappearing parasitaemia will be treated with SP. If accepting to participate in this study the children will be visited once a week and a capillary blood sample will be drawn. The blood sample taken on the day of reappearing parasitaemia in the chloroquine/amodiaquine study will be used as the day 0 blood sample in the SP-study.

If the child gets malaria during the follow-up he will be treated according to the guidelines of the Bandim Health Centre. All treatment during follow-up will be free.

Eligibility criteria: Inclusion Criteria:

* Malaria symptoms plus positive malaria film
* \> 20 parasites per 200 leukocytes
* Treatment failure in a study comparing chloroquine and amodiaquine
* Informed consent

Exclusion Criteria:

* Stated allergy to sulfadoxine and/or pyrimethamine

Primary outcomes:
measure: Re-appearing parasitaemia
Secondary outcomes:
Other outcomes:
Locations:
city: Apartado 861
country: Guinea-Bissau
facility: Bandim Health Project
state: Bissau
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06710353: The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery
Official title: The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Pediatric Cardiac Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 190
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to evaluate whether preoperative albumin supplementation in pediatric patients with hypoalbuminemia undergoing cardiac surgery can reduce inflammatory responses and prevent acute kidney injury (AKI) following cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass
* Preoperative serum albumin level of 4.0 g/dL or lower

Exclusion Criteria:

* abnormal preoperative creatinine level
* history of dialysis
* liver dysfunction
* diabetes
* history of hypersensitivity to albumin
* coagulation disorders

Primary outcomes:
measure: incidence of acute kidney injury (AKI)
timeFrame: assessed up to postoperative day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02187653: Intraoperative Monitoring (IOM) Patient Registry
Official title: Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraoperative Monitoring
Spinal Diseases
Keywords: IOM
IONM
Intraoperative Monitoring
Intraoperative Neuromonitoring
Spine
Lumbar
Cervical
Lead sponsor: DC2 Healthcare
Sponsor class: INDUSTRY
Collaborators: name: National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation
name: National Research Independent Operations Management
First posted: 2014-07-11
Enrollment: 10000
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: Patients undergoing cervical or lumbar surgery in which intraoperative monitoring has been utilized.

Brief summary: The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.

Detailed description: Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM.

Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lumbar or cervical surgery
* Utilization of IOM
* Understand and sign informed consent

Exclusion Criteria:

* There are no specific exclusion criteria

Primary outcomes:
measure: Change from baseline in Neurological Assessment at 24 hours
timeFrame: baseline and 24 hours from time of surgery
measure: Change in Pain Intensity from Baseline at 24 hours
timeFrame: baseline and 24 hours from time of surgery
measure: Complications
timeFrame: At time of surgery
measure: Change from baseline in Neurological Assessment at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change in Pain Intensity from Baseline at 6 weeks
timeFrame: baseline and 6 weeks
measure: Complications
timeFrame: 24 hours after surgery
measure: Complications
timeFrame: 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: DC2 Healthcare
state: Tennessee
Study officials:
References:
Clinical trial NCT05006053: i-Minds Professional Stakeholders Qualitative Study
Official title: A Qualitative Study of Healthcare Professionals' Perceptions About a Digitally Mediated Intervention for Young People Who Have Experienced Online Sexual Abuse and Its Integration Into Existing NHS and E-therapy Infrastructure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Sexual Abuse, Confirmed, Sequela
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Greater Manchester Mental Health NHS Foundation Trust
name: NHS Lothian
name: Pennine Care NHS Foundation Trust
name: Manchester University NHS Foundation Trust
First posted: 2021-08-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare professionals who work within NHS services in Greater Manchester and Edinburgh that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support nationwide to young people (e.g. Kooth)

Brief summary: The main aim of this study is to understand healthcare professionals' perceptions, as well as the barriers and enablers (and unintended consequences), relevant to the uptake of the digital intervention and its future integration into existing NHS infrastructure. We will use a qualitative study design and utilise semi-structured interviews and focus groups to gather the views and opinions from up to 30 healthcare professionals who work with young people to provide mental health and / or sexual assault care across two sites: Greater Manchester, UK and Edinburgh, Scotland.


Eligibility criteria: Inclusion Criteria:

* Participants will be up to 30 healthcare professionals who work within NHS services that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support to young people (e.g. Kooth).

Exclusion Criteria:

* None

Primary outcomes:
measure: i-Minds Professional Stakeholders Qualitative Study
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
state: Lancashire
city: Manchester
country: United Kingdom
facility: Manchester University Foundation Trust
state: Lancashire
city: Manchester
country: United Kingdom
facility: Pennine Care NHS Foundation Trust
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
References:
Clinical trial NCT04670653: Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis
Official title: National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Magnólia nasal gel in the treatment of moderate-severe persistent or moderate-severe intermittent allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 12 years;
* Clinical diagnosis of moderate-severe persistent or moderate-severe intermittent allergic rhinitis, according to the ARIA classification;
* Present the general status of rhinitis as moderate or severe;
* Total nasal symptom score greater than or equal to 6 points, with congestion and one or more of the other symptoms present (itching, runny nose, and sneezing) with a score greater than or equal to 2 at the screening visit;
* Present skin sensitization test to at least one aeroallergen;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year before this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to the formula components used during the clinical trial;
* Participants who present other clinical forms of rhinitis, such as, but not restricted to medicated rhinitis, vasomotor and atrophic;
* Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy;
* Participants with suggestive signs of upper airways bacterial infection;
* Participants with grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction;
* Concomitant chronic or intermittent use of decongestants, antihistamines, or corticosteroids by inhalation, oral, intramuscular, or intravenous;
* Concomitant use of potent topical corticosteroids.

Primary outcomes:
measure: Change from baseline in the reflective total nasal symptom score (rESN) averaged over the entire treatment period.
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 6 to 10 weeks
Other outcomes:
Locations:
Study officials:
References: