louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05398575: Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
Official title: Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Regionshospital Nordjylland
First posted: 2022-06-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Stroke survivors struggle to meet clinical recommendations for physical exercise duration and intensity. During the past two decades, music interventions have increasingly shown effectiveness in several motor tasks in stroke rehabilitation. Additionally, music has been found effective in increasing exercise performance in athletes and other clinical populations. Based on a meta-theoretical review paper by Clark, Baker \& Taylor (2016), it was hypothesized that the therapeutic effects of music in physical exercise is modulated by the preference and task-specificity of the music. We will test this hypothesis using a three-armed randomized cross-over design comprised of the following auditory conditions: 1) a group-tailored playlist 2) radio as active control and 3) a non-music control condition during cycle ergometry cardiorespiratory exercise sessions. Participants are inpatient stroke survivors undergoing rehabilitation between 2-12 weeks post infarct.


Eligibility criteria: Inclusion Criteria:

* between 2-12 weeks post ischemic or hemorrhagic stroke
* assessed eligible to participate in cardiorespiratory exercise by the patient's primary physiotherapist and interdisciplinary team -≥18 years old

Exclusion Criteria:

* uncontrolled medical contraindications for physical activity
* severe hearing deficit or cochlear implants
* severe deficit of both auditory and visual communication not allowing for guiding the patient in the exercise task

Primary outcomes:
measure: Heart rate reserve
timeFrame: Proportion of time during the 30 minutes session
measure: Exercise time
timeFrame: Proportion of time during the 30 minutes session
Secondary outcomes:
measure: Feeling scale
timeFrame: Immediately before and after the intervention.
measure: Evaluation of condition
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: North Denmark Region
Study officials:
affiliation: Aalborg University
name: Daniel S Mazhari-Jensen, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161875: Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Helmet
Official title: Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Invasive Positive-Pressure Ventilation
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postoperative period

Brief summary: Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.


Eligibility criteria: Inclusion Criteria:

* Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery

Exclusion Criteria:

* Contra-indication to non-invasive ventilation pregnancy.

Primary outcomes:
measure: Triggering delay
timeFrame: Every inspiration, for 10 minutes
Secondary outcomes:
measure: Cycling off delay
timeFrame: Every inspiration, for 10 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care
Study officials:
affiliation: Groupe Hospitalier Pitie-Salpetriere
name: Thomas Similowski, MD, PhD
role: STUDY_DIRECTOR
affiliation: Groupe Hospitalier Pitie-Salpetriere
name: Mathieu RAUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044275: The Influence of Output on Skin Covered by Adhesive With Topfilm
Official title: The Influence of Output on Skin Covered by Adhesive With Topfilm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation -

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of preclinical department
name: Lene Feldskov, M. Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05252975: Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)
Official title: Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor, Adult
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).

Detailed description: This is a prospective, non-randomised radiotherapy planning study.

Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients.

Patients continue to receive treatment in the proposed position as recommended y their treating physician.

Eligibility criteria: Inclusion Criteria:

* • Patients undergoing Cyberknife treatment to spinal metastasis

  * \>18 years of age
  * Thoracic, lumbar and sacral spinal metastasis
  * Patients suitable to undergo radiotherapy planning CT scans in the prone position (treating physician assessed as having spinal stability).
  * All solid tumour types will be eligible

Exclusion Criteria:

* • Primary spinal tumours

  * Vertebral disease resulting in unstable spinal vertebrae
  * Cervical tumours (patients will be unable to have a thermoplastic shell made for the prone position).
  * Patients with significant pain on prone lying (to be assessed by physician prior to consent)
  * Bilsky epidural score of 2 or greater (see appendix 1)
  * Pre-existing musculoskeletal chronic back medical diagnoses that would preclude CT scanning in the prone position.

Primary outcomes:
measure: PTV isodose coverage
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Organs at risk dose
timeFrame: Immediate
measure: Comfort scores
timeFrame: Immediate
measure: CT and MRI registration
timeFrame: Immediate
measure: Treatment time duration
timeFrame: Immediate
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References:
Clinical trial NCT03354975: Experiential Training for Community Therapists
Official title: Dissemination of Exposure-Based Treatment for Anxiety: Experiential Training for Community Therapists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-11-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this study is to evaluate the feasibility and acceptability of employing an experiential training approach that targets community mental health therapists' attitudes toward and use of exposure therapy. In addition to assessing attitudes and use of exposure therapy, the study will evaluate the feasibility of recruitment, randomization, retention, and assessment processes, as well as the acceptability of the experiential training relative to training-as-usual. To assess these outcomes, community therapists will be randomized to experiential training or training-as-usual. A subset of therapists from each arm will also complete qualitative interviews to further assess acceptability of the training approaches. The training-as-usual condition will include a traditional one-day workshop that focuses on principles of exposure and incorporates active learning strategies. The experiential training will include a one-day workshop that teaches principles of exposure and has therapists themselves undergo a one-session phobia treatment for spiders. Therapists in both training conditions will be asked to attend weekly consultation phone calls for a three-month period following the trainings.


Eligibility criteria: Inclusion Criteria:

* Participants will be aged 21 and older with degrees (masters or doctorate) in a mental health field. They must be working in a community mental health clinic, currently treating at least one client with anxiety, and planning to continue providing therapy to at least one client with anxiety for the duration of the study. Participants must be interested in participating in a training workshop and able to commit to the time requirements for study completion. They must also be willing to provide an email or mailing address to complete study-related surveys. Finally, they must be able to read and speak English.

Exclusion Criteria:

* Participants cannot have previously attended a full day (8+ hours) workshop on exposure-based treatments for anxiety.

Primary outcomes:
measure: Change from baseline Therapist Beliefs about Exposure Scale (TBES) at 3-month follow-up
timeFrame: Pre-training; 3-month follow-up
measure: Change from baseline Exposure Therapy Clinical Use Survey (ETCUS) at 3-month follow-up
timeFrame: Pre-training; 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03967275: Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn
Official title: Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn SyMbOL Pre Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Donor
Keywords: Bone marrow harvest
Bone Marrow derived Mesenchymal Stem Cells (BM-MSC)
Pre-clinical
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bone marrow donors

Brief summary: The objective of this pre-clinical study is to demonstrate the robustness of Bone Marrow derived Mesenchymal Stem Cells (BM-MSC) production, to treat patients with severe eye burns.

For bone marrow donors who agree to participate, a 10 ml BM sample will be collected apart the 1 liter BM dedicated to transplantation.

A maximum of three donors of allogeneic BM-MSCs will be included. A ready-to-use BM-MSC suspension will be produced and stored for 10 years to accumulate data about stability of cryopreserved cells.


Eligibility criteria: Inclusion criteria:

- Patient with a bone marrow donation planned

Exclusion criteria:

* The donor is finally not eligible
* The harvest cannot be performed
* The sample cannot be obtained during the BM harvest procedure

Primary outcomes:
measure: The number of donors needed to obtain 3 BM harvest.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Louis Hospital, APHP
Study officials:
References:
Clinical trial NCT00747175: A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
* Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
* HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Primary outcomes:
measure: Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
name: Klas Malmberg, MD, Phd, Prof
role: STUDY_DIRECTOR
affiliation: Profil Institute for Clinical Research, Inc.
name: Marcus Hompesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772575: A Study to See if we Can Predict How Your Liver Tumor or Liver Metastases Will Respond to Trans-Arterial Embolization (TAE)
Official title: A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Liver Cancer
Liver Metastases
Keywords: MOLECULAR PREDICTORS
Hepatic trans-arterial embolization (TAE)
16-385
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 0
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: Potential research subjects will be identified by a member of the patient's treatment team, listed protocol investigators, or Interventional Radiology research team at Memorial Sloan Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Identifying a gene that can predict how liver tumors will respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.


Eligibility criteria: Inclusion Criteria:

* Histopathologic evidence of primary liver cancer or liver metastases
* Indication of TAE for the treatment of liver tumor
* Age ≥ 18 years
* Available tissue with adequate tissue for analysis, verified by a pathologist

Exclusion Criteria:

* History of a second active malignancy with evidence of metastatic disease

Primary outcomes:
measure: response
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Etay Ziv, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00327275: The Effects of a 16-Week Individualized, Intensive Strength Training Program in Patients With Rheumatoid Arthritis
Official title: The Strength Training and Remicade Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2006-05-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life.

We hypothesized that improvements would be seen in all of the above outcomes.


Eligibility criteria: Inclusion Criteria:

* Males and females with RA
* Over 18 years of age
* ACR Functional Class I and II
* Taking Remicade \>4 months

Exclusion Criteria:

* Presence of comorbid conditions contraindicated to exercise, including, but not limited to:

  1. heart disease
  2. severe osteoporosis: (if \>50 years): T score \< -3.0 for hip or spine excluded; T score \<-2.5 for hip or spine w/o current treatment)
  3. (all potential subjects) previous non-traumatic fractures
  4. uncontrolled BP
* BMI \>40
* Regular use of assistive walking device which would interfere with ability to lift weights
* Currently or within the last 3 months participating in aerobic exercise \> 150 minutes a week
* Currently or within the last 3 months participating in any regular strength training activities
* Presence of neurological impairment that directly limits ability to perform exercise
* Participation in concurrent exercise study
* Any reason for which the investigator deems it would not be in the patient's best interest to continue in the study
* Plans to move away from site within next 1 year

Primary outcomes:
measure: Strength
measure: Body Composition
measure: Function
measure: Pain
Secondary outcomes:
measure: Quality of Life
measure: Disease Activity
measure: Fatigue
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: Idaho State University
name: Hilary G Flint-Wagner, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: