louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03359772: Kinesthetic Ability Trainer for Peripheral Neuropathic Pain
Official title: Effectiveness of Balance Training With Kinesthetic Ability Trainer-KAT2000 in Patients With Peripheral Neuropathic Pain: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Neuropathic Pain
Balance
Kinesthetic Ability Trainer
Quality of Life
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 64
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To determine the effectiveness of balance training with Kinesthetic Ability Trainer 2000 (KAT 2000) in patients with peripheral neuropathic pain related balance disorder.

Methods: A total of 60 patients who developed peripheral neuropathic pain-related balance impairment in the chronic phase due to lumber disc herniation, lumber spondylosis and gonarthrosis were included into this randomized controlled prospective study and randomized into either balance exercises groups or KAT 2000 exercises groups. Balance exercises were given all patients in Group 1 (n=30). In addition to balance exercises, KAT 2000 balance exercises were given all patients in group 2 (n=30). All patients received 45-min individualized training session for three times a week for 4 weeks. Patients were evaluated according to pain, static and dynamic balance and quality of life (QoL).

Detailed description: Neuropathic pain was determined by the Douleur Neuropathique 4 (DN4) questionnaire. Pain severity was assessed by using a visual analogue scale (VAS). KAT 2000 was used to evaluate static and dynamic balance. Dynamic balance and mobility also was assessed using the Berg Balance Scale (BBS) and Time Up and Go (TUG) test. QoL was assessed by using Nottingham Health Profile (NHP). Patients were evaluated at baseline and the end of the 4-week exercise program.

Eligibility criteria: Inclusion Criteria:

* DN4 scores ≥4 and moderately impaired balance with a score of 21-40 points on the Berg Balance Scale.

Exclusion Criteria:

* Who had history of previous cerebrovascular events; other neurological, musculoskeletal, inner ear or eye disease that may lead to impaired vision or standing balance.

Primary outcomes:
measure: Douleur Neuropathique 4
timeFrame: 1 months
Secondary outcomes:
measure: visual analogue scale
timeFrame: 1 months
measure: Berg Balance Scale
timeFrame: 1 months
measure: Time Up and Go Test
timeFrame: 1 months
measure: Nottingham Health Profile
timeFrame: 1 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
affiliation: Ufuk University
name: DUYGU KERİM
role: STUDY_CHAIR
affiliation: Ufuk University
name: Saime AY
role: STUDY_CHAIR
References:
Clinical trial NCT00923572: Yasmin Post Marketing Surveillance
Official title: Yasmin Regulatory Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Oral contraceptive
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 777
Sex: FEMALE
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: Korean women who need oral contraceptive

Brief summary: The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.


Eligibility criteria: Inclusion Criteria:

* Women who need oral contraceptive

Exclusion Criteria:

* Patient who belongs to contraindication listed on the product label.

Primary outcomes:
measure: Safety and efficacy in real practice
timeFrame: After 6 cycle of treatment
Secondary outcomes:
measure: Demography
timeFrame: At initial visit
measure: Medical History
timeFrame: At initial visit
measure: Administration period of Yasmin
timeFrame: After 6 cycle of treatment or at the point of withdrawan
measure: Patient's compliance
timeFrame: After 6 cycle of treatment or at the point of withdrawan
measure: Adverse Event / Serious AE collection
timeFrame: At point of the occurence
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04567472: HEADS: UP Online Psychological Self-management Intervention: Feasibility 2
Official title: HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Online Psychological Self-management Intervention: Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
CVA (Cerebrovascular Accident)
Anxiety
Depression
Keywords: Stroke
CVA
Anxiety
Depression
Mindfulness
MBSR
Online
Self-management
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To test feasibility of online version of HEADS: UP

Detailed description: Study aim(s): to conduct feasibility testing of online HEADS: UP, a tailored adaptation of an existing psychological intervention (MBSR) to help people affected by stroke self-manage symptoms of anxiety and depression.

Objectives: 1) Assess feasibility and acceptability of delivering the HEADS: UP intervention online and identify any additional adaptations to the HEADS: UP manual and supporting materials. 2) Assess feasibility and acceptability of online research processes, including recruitment, screening, and obtaining informed consent, and data collection processes.

Research question: What elements of intervention design, delivery, and study processes require to be optimised ahead of a 3-arm RCT?

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Have had ≥1 stroke at least 3 months previously
* Interested in learning skills to help cope with self-reported anxiety and/or depression
* Able to speak and understand conversational English
* Score ≥ 4 on either sub-scale Hospital Anxiety and Depression Scale (HADS)
* Desirable: Able to identify a family member/peer who would: like to take part, can speak and understand conversational English; not participating in another trial.

Potential participants who do not identify someone else to take part with them will not be excluded.

Exclusion Criteria:

* Prior MBSR attendance in the last three years (as this may confound results)
* Current participant in another trial
* Cannot follow a 2-stage command

Primary outcomes:
measure: Beck Depression Inventory II (BDI-II): change is being assessed
timeFrame: Weeks 0, 9
measure: Beck Anxiety Inventory (BAI): change is being assessed
timeFrame: 0, 9 weeks
measure: . Depression Anxiety Stress Scale (DASS): change is being assessed
timeFrame: Weeks 0, 9
measure: EQ-5D 5L: change is being assessed
timeFrame: Weeks 0, 9
measure: Stroke Impact Scale (SIS): change is being assessed
timeFrame: Weeks 0, 9
measure: Focus group
timeFrame: Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Glasgow (City Of)
Study officials:
affiliation: Glasgow Caledonian University
name: Maggie Lawrence, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00006072: A Study of Rituxan in the Treatment of Polyneuropathies Associated With Serum IgM Autoantibodies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Neuropathy
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Genentech, Inc.
First posted: 2000-07-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Peripheral neuropathies cause weakness and sensory loss that can produce severe disability. Some neuropathies are immune-mediated and associated with antibodies. It has been postulated that Rituxan treatment may reduce the level of antibody production limiting the loss of muscle strength and hence improve activities of daily living. The purpose of this open-label study (all participants get Rituxan and not placebo) is to determine the safety and effectiveness of Rituxan in the treatment of polyneuropathies associated with serum IgM autoantibodies in those who have already been treated with one course of Rituxan. Subjects will be treated on the in-patient Clinical Research Center with Rituxan for two treatments one week a part and then individual treatments every 10 weeks for one year. The effectiveness of Rituxan will be followed by looking for increases in muscle strength and decreases in the serum IgM autoantibodies.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of characteristic peripheral neuropathy by appropriate history, physical examination, nerve conduction findings and serum autoantibodies.
* Serum anti-GM1 on anti-MAG antibodies present at high titers in serum, continued by testing in the neuromuscular clinical laboratory at Washington University.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00528138: Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation
Official title: Prospective Study Comparing Hyperbilirubinemia, CRP, White Blood Cell Count, and Other Clinical Parameters for the Preoperative Diagnosis of Perforated Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforated Appendicitis
Keywords: Appendicitis
Hyperbilirubinemia
CRP
Values of bilirubin
Values of liver function test
Values of white blood cells
Values of CRP
Lead sponsor: Cirujanos la Serena
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 132
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of having acute appendicitis

Brief summary: It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis.

The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters, are more specific markers for the preoperative diagnosis of perforated acute appendicitis.

The purpose of this study is to prospectively compare the specificity and sensitivity of hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the preoperative diagnosis of acute appendicitis.

Detailed description: * Previously validated appendicitis score
* Time from onset of symptoms to diagnosis and to surgery
* Laboratory values: WBC, CRP, liver function test
* SIRS values
* Preoperative and postoperative diagnosis
* Length of hospital stay
* Postoperative complications
* Biopsy results

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for appendectomies for acute appendicitis at the emergency unit of our institution
* Patients older than 15 years of age to 100 years of age

Exclusion Criteria:

* Appendectomy performed incidentally or for other indications
* Patients younger than 15 years of age
* Alcoholism
* A history of viral hepatitis
* Gilbert's disease
* Dubin Johnson syndrome
* BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary
* Hemolytic or liver diseases associated with hyperbilirubinaemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Hospital De La Serena - Emergency Unit
state: IV Region
Study officials:
affiliation: Hospital de La Serena
name: Marcelo A Beltran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de La Serena
name: Rodrigo Barrera, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03484338: Accelerated Resolution Therapy for Complicated Grief
Official title: Accelerated Resolution Therapy for Treatment of Complicated Grief in Senior Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Depressive Symptoms
Trauma, Psychological
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will examine whether accelerated resolution therapy (ART) is effective for the treatment of prolonged and complicated grief and associated psychological trauma among older adult hospice caregivers who have experienced the death of an immediate family member at least 12 months ago.

Detailed description: ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers. Mental health professionals are delivering ART in clinical practice to assist with grief; however, there is a need for formal research evaluation of the effects of ART on complicated grief and psychological distress.

Eligibility criteria: Inclusion Criteria:

* Adult age 60 years of age or older
* previous primary caregiver of immediate family member who died after enrollment in hospice with the death occurring at least 12 months prior to enrollment
* current symptoms indicative of proposed diagnostic criteria for complicated grief disorder, as proposed by Shear et al. (2011)
* current score of \>25 on the 19-item Inventory of Complicated Grief
* current symptoms indicative of significant psychological trauma, as documented by score \>33on the 20-item DSM-5 PTSD checklist (PCL-5)26 or score \>4 on the PDSQ PTSD subscale
* denial of suicidal ideation or intent, with no evidence of psychotic behavior

Exclusion Criteria:

* engaged in another psychotherapy regimen that could also influence symptoms of PCG - - major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery
* current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery.

Primary outcomes:
measure: change in complicated grief symptoms
timeFrame: 4 weeks, follow up at 12 weeks
measure: change in psychological trauma
timeFrame: 4 weeks, follow up at 12 weeks
measure: change in depressive symptoms
timeFrame: 4 weeks, follow up at 12 weeks
Secondary outcomes:
measure: change in stress response
timeFrame: weekly pre to post ART and over the 4 week intervention period
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Harleah Buck
state: Florida
Study officials:
affiliation: University of South Florida
name: Harleah Buck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04018638: Blood-Flow Restriction Exercise Following a Knee Replacement
Official title: B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Injuries
Knee Osteoarthritis
Knee Arthritis
Lead sponsor: Michigan Technological University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2019-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).

Detailed description: This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.

Eligibility criteria: Inclusion Criteria

* 40-75 years of age
* Have had a unilateral TKA \> 6 months prior to participation (Arm 1)
* No previous history of knee injury/surgery (Arm 2)

Exclusion Criteria

* Are a smoker
* Have diabetes
* Have suffered a heart attack or stroke
* Have any cardiopulmonary disorders (hypertension discussed below)
* Have been diagnosed with any neurological disorders
* Have any implanted devices such as but not limited to a pacemaker or pain pump
* Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension

Primary outcomes:
measure: Change in Muscle size
timeFrame: Change from baseline at 10 weeks
measure: Change in Muscle strength
timeFrame: Change from baseline at 10 weeks
Secondary outcomes:
measure: Change in Walking performance
timeFrame: Change from baseline at 10 weeks
measure: Change in Balance
timeFrame: Change from baseline at 10 weeks
Other outcomes:
Locations:
city: Houghton
country: United States
facility: Michigan Technological University
state: Michigan
Study officials:
affiliation: Michigan Technological University
name: Steven Elmer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01939938: Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment
Official title: Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With Positive Airway Pressure Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. The goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with CPAP in order to investigate differences in upper airway dynamics that may occur between these two mask types.

Detailed description: It is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered breathing. However, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. The objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using real-time cine magnetic resonance imaging (cMRI).

Eligibility criteria: Inclusion Criteria:

* AHI\> 30/hr
* 18-75 years of age

Exclusion Criteria:

* History of claustrophobia
* History of pacemaker, nerve stimulator, or any other metal implanted device

Primary outcomes:
measure: AHI
timeFrame: through study completion, an average of 1 hour
Secondary outcomes:
measure: MRI of Upper Airway With Opposite PAP Mask
timeFrame: Approximately 1 hour
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Center for Sleep Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Matthew Ebben, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebben MR, Milrad S, Dyke JP, Phillips CD, Krieger AC. Comparison of the upper airway dynamics of oronasal and nasal masks with positive airway pressure treatment using cine magnetic resonance imaging. Sleep Breath. 2016 Mar;20(1):79-85. doi: 10.1007/s11325-015-1187-x. Epub 2015 Apr 30.
Clinical trial NCT00460538: Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms
Official title: Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal allergic rhinitis
lectranal
allergy
Lead sponsor: Milsing d.o.o.
Sponsor class: OTHER
First posted: 2007-04-16
Enrollment: 48
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: The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Detailed description: Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.

Eligibility criteria: Inclusion Criteria:

* history of seasonal allergic rhinitis symptoms to pollen
* positive skin prick test to pollen
* negative history of seasonal allergic asthma
* male or female older than 18
* female participants must use appropriate contraception
* able to comply to study procedures

Exclusion Criteria:

* pregnancy
* alcohol or drug abuse
* subject receiving antihistamines , immunotherapy or on hyposensibilisation

Primary outcomes:
measure: changes in SARS (seasonal allergic rhinitis symptoms)
timeFrame: 6 weeks
measure: changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)
timeFrame: 6 weeks
measure: changes in specific IgE
timeFrame: 6 weeks
measure: changes in specific IgG
timeFrame: 6 weeks
Secondary outcomes:
measure: Prick test change
timeFrame: 6 weeks
measure: change in eosinophilia in nasal secretion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Dubrava University Hospital
Study officials:
affiliation: Dubrava University Hospital
name: Neven Tudoric, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matkovic Z, Zivkovic V, Korica M, Plavec D, Pecanic S, Tudoric N. Efficacy and safety of Astragalus membranaceus in the treatment of patients with seasonal allergic rhinitis. Phytother Res. 2010 Feb;24(2):175-81. doi: 10.1002/ptr.2877.