louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01345890: Cortical Neuromodulation in Post Stroke Dysphagia
Official title: Neuromodulation in Post Stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: swallowing
stroke
aspiration
human
electrical stimulation
post stroke dysphagia
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.

Detailed description: Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.

The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing

Eligibility criteria: Inclusion Criteria:

* post stroke dysphagia

Exclusion Criteria:

* contraindication to magnetic stimulation, unability to accept the study

Primary outcomes:
measure: videofluoroscopy
timeFrame: before and after (once a day for 5 consecutive days)
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen Universty Hospital
Study officials:
affiliation: Rouen University
name: Eric VERIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06203990: Barre Exercise in Parkinson's
Official title: Barre Exercise for People With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 13
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 study asks if a barre exercise program is a feasible and acceptable form of exercise for individuals with Parkinson disease. The study will also evaluate barre's potential effects on motor outcomes, including balance, strength, and functional mobility.

Detailed description: The primary objectives of this study are to: 1) evaluate the feasibility and acceptability of a barre exercise intervention and 2) gather preliminary data regarding the effect of a barre exercise intervention on balance, strength, functional mobility and quality of life in individuals with mild to moderate Parkinson disease (PD). Individuals with PD (N=15) will be recruited to participate in a pilot barre exercise class led by a certified barre instructor. The intervention will include 24, 45-50 minute group classes (twice weekly for 12 weeks, excluding holidays). Pre- and post-intervention data collection will include assessments of balance, lower extremity strength, and functional mobility.

Eligibility criteria: Inclusion Criteria:

* diagnosed by a neurologist with idiopathic Parkinson disease
* at least 18 years of age
* a score on the Hoehn \& Yahr (H\&Y) scale between I-III to indicate mild to moderate disease severity
* able to provide informed consent
* able to walk for 10 continuous minutes without assistance from another person
* stable medication regimen for at least one month prior to enrollment

Exclusion Criteria:

* any neurological condition other than PD
* history of orthopedic or other medical conditions that limit the ability to safely participate in the intervention or
* language, visual, or hearing barriers to participation
* evidence of dementia (Montreal Cognitive Assessment \< 24) to ensure understanding of the intervention class instructions

Primary outcomes:
measure: Attendance
timeFrame: 12 weeks
measure: Study Completion
timeFrame: 12 weeks
Secondary outcomes:
measure: Balance
timeFrame: 12 weeks
measure: Functional Strength
timeFrame: 12 weeks
measure: Gait
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT06241690: Cold Applications on the Pain Level of Children With Sutures
Official title: the Effect of Post-suture Cold Applications on the Pain Level of Children With Sutures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Keywords: Cold Application
child
Nurse
Pain
suture
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose:This research was conducted as an experimental study with pretest and posttest control groups in order to evaluate the effect of post-suture cold applications on the pain level of children with sutures.

Design and Methods: This study is a randomised controlled study. In the study, there were 150 children in the experimental group and 150 children in the control group.

Detailed description: The experimental groups was applied at the 1st, 2nd and 6th hours after the suture application in the cold applications The different practitioners applied in the Visual Analog Scale after and before in the cold applications to the experimental and control groups

Eligibility criteria: Inclusion Criteria:

* parents who agreed to participate in the study

Exclusion Criteria:

* -visually impaired child
* mentally retarded child
* speech impaired children
* without chronic disease

Primary outcomes:
measure: this study was measured the effects of cold application in the children after the suture
timeFrame: 1 days
Secondary outcomes:
Other outcomes:
Locations:
city: Elazıg
country: Turkey
facility: Fırat University
state: Campus
Study officials:
References:
Clinical trial NCT01795690: Clinical Tumor Anemia Registry (TAR)
Official title: Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: Anemia
Cancer
Hemoglobin
Quality of Life
FACT-An
FACT-GP
Erythropoiesis-Stimulating Agents (ESA)
Epoetin
Ferric Carboxymaltose
Blood Transfusions
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)
First posted: 2013-02-21
Enrollment: 1018
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 with malignant diseases starting anti-anemic treatment

Brief summary: The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignant disease
* Hemoglobin level \< 11 g/dl (female) or \< 12 g/dl (male)
* Start of antianemic therapy no more than 7 days prior to informed consent
* Performance status 0 - 3 (Karnofsky-Index \>= 40%)
* Minimum age: 18 years
* Informed written consent

Exclusion Criteria:

* Hypersensitivity against antianemic therapies
* Myelodysplastic Syndrome
* Experimental antianemic therapy

Primary outcomes:
measure: Documentation of therapies
timeFrame: 12 weeks per patient
Secondary outcomes:
measure: Change in hemoglobin levels and QoL
timeFrame: 12 weeks per patient
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO
Study officials:
References:
citation: Steinmetz T, Schroder J, Plath M, Link H, Vogt M, Frank M, Marschner N. Antianemic Treatment of Cancer Patients in German Routine Practice: Data from a Prospective Cohort Study-The Tumor Anemia Registry. Anemia. 2016;2016:8057650. doi: 10.1155/2016/8057650. Epub 2016 Feb 4.
Clinical trial NCT02034890: Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection
Official title: Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: orthotopic neobladder
urinary tract infection
intravesical instillation
hyaluronic acid
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.


Eligibility criteria: Inclusion Criteria:

* patients undergoing radical cystectomy and orthotopic neobladder reconstruction

Exclusion Criteria:

* patients \<18 years and unwilling to participate in this study

Primary outcomes:
measure: positive urinary culture
timeFrame: 6 months
Secondary outcomes:
measure: urinary tract infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Petach Tiqva
country: Israel
facility: Urology department, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Hanan Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06630390: Daridorexant to Prevent Delirium After Heart Surgery
Official title: Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: POSTOPERATIVE DELIRIUM
POSTOPERATIVE COGNITIVE DECLINE
Keywords: delirium
sleep
cognitive decline
Alzheimer disease and related dementias
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the daridorexant or placebo arm.
Primary purpose: PREVENTION

Brief summary: The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.

Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.


Eligibility criteria: Inclusion Criteria:

* Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital
* Can provide informed consent
* Able to speak, read, and write English
* Family member or close friend available for collateral

Exclusion Criteria:

* Prior heart surgery
* Infectious endocarditis
* Emergency surgery
* Delirium at baseline
* Auditory/visual impairment preventing study procedures
* Active alcohol or substance misuse
* Psychotic disorder
* Dementia-level deficits
* Use of a sleep aid before surgery
* Use of a strong 3A4 inhibitor
* Intolerance to daridorexant
* Severe kidney or liver impairment
* Narcolepsy
* Any condition that, in the opinion of the PI, compromises patient safety or data quality if enrolled in the study

Primary outcomes:
measure: Delirium
timeFrame: First 3 days after surgery (continued up to 1 week if delirious on postop day 3)
Secondary outcomes:
measure: Sleep disturbance
timeFrame: First 3 days after surgery (continued up to 1 week if delirious on postop day 3)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04116190: A Multidisciplinary Telerehabilitation for Stroke Patients
Official title: Feasibility of Multidisciplinary Telerehabilitation in Patients With Stroke - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Keywords: rehabilitation
stroke
Lead sponsor: Vetrea Terveys Oy
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consecutive sampling
Primary purpose: OTHER

Brief summary: Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients.

Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only.

Intervention: A rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. The control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting.

Outcome and measures: Change in the Finnish version of Functional Status Questionnaire (FSQFin), the World Health Organization Quality of Life - Short version (WHOQOL-Bref), the Barthel Index, the Beck Depression Inventory (BDI21), and the Goal Attainment Scale (GAS) and a patient satisfaction questionnaire.


Eligibility criteria: Inclusion Criteria:

* chronic stroke (6 months or more) patient living in home
* eligible to receive rehabilitation funded by the Social Insurance Institution (meets the criteria of chronic disability and need for rehabilitation)
* for intervention group: capable to use a personal computer and telecommunication

Exclusion Criteria:

* no access or capability to use a personal computer
* significant problems in hearing, seeing or understanding information related to the intervention

Primary outcomes:
measure: Finnish version of the Functional Status Questionnaire (FSQfin)
timeFrame: 8 weeks
Secondary outcomes:
measure: World Health Organization Quality of Life - short version (WHOQOL-Bref)
timeFrame: 8 weeks
measure: Beck Depression Inventory (BDI 21)
timeFrame: 8 weeks
measure: Barthel Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Vetrea
state: North Savo
Study officials:
affiliation: VetreaNeuron
name: Kauko Pitkanen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01586390: Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
Official title: Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ankle Sprain
Ankle Ligament Rupture
Ankle Injuries
Keywords: Ankle Sprain
Ankle Distortion
Functional treatment
Brace treatment
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.

Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.


Eligibility criteria: Inclusion Criteria:

• Grade 2 and 3 acute ankle sprains

Exclusion Criteria:

* history of ankle sprains with persistent instability
* grade I lateral ankle sprains
* ankle fracture
* bilateral ankle sprains
* previous ankle ligament surgery
* neuromuscular disorders of the lower extremities
* rheumatoid arthritis,
* alcoholism,
* serious psychiatric or neurological illness

Primary outcomes:
measure: Functional scores according to Karlsson score
timeFrame: Follow-up of 4 months
Secondary outcomes:
measure: Pain
timeFrame: follow-up of 4 months
measure: Satisfaction score
timeFrame: follow-up of 4 months
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
facility: Spaarneziekenhuis
Study officials:
affiliation: Spaarne Gasthuis
name: Daniel Mensch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629090: Brain Blood Vessel Responses to Changes in Blood Flow: Younger Cohort
Official title: Cerebrovascular Responses to Acute Hypoperfusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Magnetic Resonance Imaging
Cerebrovascular Circulation
Keywords: Magnetic Resonance Imaging
Brain Blood Flow
Lower Body Negative Pressure
Carbon Dioxide
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

Detailed description: Global cerebral blood flow (CBF) decreases with advancing age; however, some adults have accelerated declines in CBF, placing them at a greater risk of cognitive impairment. However, there is a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain. This study will systematically address this gap in knowledge by examining cerebrovascular control in adults during acute physiological challenges (simulated postural change test and breathing increased carbon dioxide) that stimulate a change in CBF.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-40 years
* Have a BMI ≤34.5 kg/m2
* Nonsmoker

Exclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD)
* History or evidence of hepatic disease, hematological disease, or peripheral vascular disease; severe kidney injury requiring hemodialysis
* History of cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
* Uncontrolled hypertension
* History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
* Severe untreated obstructive sleep apnea
* History of diabetes with HbA1c greater than 9.5%
* Major neurologic disorders other than dementia (e.g., MS, ALS, brain surgery, etc.)
* Current or recent (\&lt;1 year) major psychiatric condition (Axis I) or addictive disorders
* Significant surgical history
* Other significant medical conditions at investigators' discretion
* Contraindications to MRI
* Prescribed medications that interfere with prazosin
* Lactose allergy

Primary outcomes:
measure: Change in blood velocity
timeFrame: Two study visits, up to 240 minutes
measure: Change in blood flow
timeFrame: Two study visits, up to 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT00168090: Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
Official title: Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Von Willebrand Disease
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Disease
Keywords: von Willebrand Factor
Blood Coagulation Disorders
Factor VIII
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.


Eligibility criteria: Key Inclusion Criteria:

* Subjects of any age
* Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP
* Require substitution with vWF/FVIII complex due to a surgery

Key Exclusion Criteria:

* Known significant hemostatic disorder other than vWD
* Acquired vWD
* Known antibodies to FVIII or vWF
* Known platelet type vWD
* Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol
* History of allergic reaction to Humate-P®
* Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents)
* Progressive fatal disease/life expectancy of less than 6 months
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment
* Pediatric patients of insufficient body weight to permit PK sampling
* Woman in the first 20 weeks of pregnancy

Primary outcomes:
measure: To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.
Secondary outcomes:
measure: To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.
Other outcomes:
Locations:
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.
name: Marylin J. Manco-Johnson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: