louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00485641: Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients
Official title: Screening of Inpatient Rehabilitation Stroke Patients for Their Potential to Qualify to Use the Saeboflex Dynamic Hand Orthosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
SaeboFlex
Hand function
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Saebo, Inc.
First posted: 2007-06-13
Enrollment: 222
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to determine what the potential utility of the Functional Tone Management (F.T.M) Arm Training Program using the SaeboFlex in an inpatient stroke rehabiliation hospital

Detailed description: Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the last 2 years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury outpatient population. Two factors, other than the severity of the initial injury, have been clinically identified as having a significant affect on the outcomes achieved in F.T.M. Arm Training treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the potential patient population that may qualify to use the SaeboFlex Dynamic Hand Orthosis as a therapeutic option in the inpatient population.

Eligibility criteria: Inclusion Criterion:

* All patients admitted to the Stroke Rehabilitation Program at the Kessler Institute for Rehabilitation locations (East Orange, Saddlebrook, and Chester).
* Approval from treating physician.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chester
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: East Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Saddle Brook
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Kessler Medical Rehabilitation Research & Education Center
name: Elie P Elovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03816241: Mechanisms of Nudges on Families' Decision-Making Process
Official title: Mechanisms of Nudges on Families' Decision-Making Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donation
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to 1 out of 4 possible anecdotes; Control, Framing, Norms, Combination.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As part of a larger study, participants are told to read 1 out of 4 anecdotes depicting an organ donation scenario where they are required to make a decision on behalf of their mother who has just suffered an accident. The participants are then surveyed on their attitudes towards organ donation.

Detailed description: As part of a larger study, participants are given 1 out of 4 possible vignettes which depicts an organ donation scenario involving their mother. The possible vignettes consist of a Control condition, a Framing condition, a Normative condition and a condition that includes all the nudges. Participants are then given surveys to gauge their views and attitudes towards organ donation as a whole, their trust towards medical institutions and the doctors, their perceived manipulation from the doctor and their views on the altruistic nature of organ donation.

Eligibility criteria: Inclusion Criteria:

* Above age 21
* Singapore Citizens and Permanent Residents

Exclusion Criteria:

* Below age 21
* Non-citizens
* Not able to make decisions for self

Primary outcomes:
measure: 5-point Likert scale - Trust and Perceived Manipulativeness of doctor and medical institution
timeFrame: 3 minutes
measure: 9-point rating scale - Views on altruistic nature of organ donation
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
Clinical trial NCT03839641: Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Official title: Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching aim of this study: To determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to nadir, slope).


Eligibility criteria: Inclusion Criteria:

* Eligibility criteria include:

  * Healthy male or female
  * Ages 18-40 y
  * BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
  * Are willing to consume pre-prepared meals
  * Are willing to maintain current physical activity, sleep schedule, and dietary habits during the study.
  * Medically cleared for participation in the study by Medical Investigator

Exclusion Criteria:

* Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:

  * Unstable weight in the last 3 months \[gain or loss \>7 lb (or 3.2 kg)\]
  * Currently working shift work
  * Smoking or use of tobacco products within the last 3 months
  * Amenorrhea (or absence of regular monthly cycles)
  * History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
  * Average screening blood pressure \>140/90 mmHg
  * Previous bariatric surgery (or other surgeries) for obesity or weight loss
  * Use of medications affecting metabolism or sleep
  * History of neurological disease
  * History of cardiovascular disease (or other chronic diseases)
  * Pregnant, planning to become pregnant, or breastfeeding
  * Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over the last 3 months.

Primary outcomes:
measure: Overnight Respiratory Exchange Ratio
timeFrame: 12 hours
Secondary outcomes:
measure: Sleep Respiratory Exchange Ratio
timeFrame: 3 h
measure: Peak Increase in Respiratory Exchange Ratio
timeFrame: 4 h
measure: Peak Decrease in Respiratory Exchange Ratio
timeFrame: 12 h
measure: Time to Peak Respiratory Exchange Ratio
timeFrame: 12 h
measure: Time to Nadir Respiratory Exchange Ratio
timeFrame: 12 h
measure: Slope of Respiratory Exchange Ratio
timeFrame: 12 h
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT02360241: Light Needle Positioning Robot Under MRI Guidance
Official title: LPRobacus: Light Needle Positioning Robot Under MRI Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Robotic Surgical Procedures
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
First posted: 2015-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study aim is to evaluate the needle positioning precision, compared to the real path planned by the physician on healthy voluntaries, by positioning a fictional needle, without inserting it.

Additionally, this study will evaluate:

* the robot precision,
* the robot detection robustness,
* the software and device ergonomics,
* the device security.


Eligibility criteria: Inclusion Criteria:

* person over 18 years old,
* person with height is under 1m90,
* person with abdomen height is under 28 cm,
* person with abdomen width is between 26 cm to 50 cm,
* person able to hold his breath during 30 seconds,
* person affiliated to social security or similarly regime,
* signed consent for participation in the study.

Exclusion Criteria:

* person with a contraindication for abdomen MRI,
* claustrophobic person,
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Primary outcomes:
measure: Amount of needle positioning needed to reach the real path wanted, with a 5mm precision (cylinder diameter including the path defined by the two skin marker and the need axe).
timeFrame: 1hour20minutes
Secondary outcomes:
measure: Number of time in percentage of failed robot use.
timeFrame: 1hour20minutes
measure: Number of time in percentage of failed fixation of the robot over the patient.
timeFrame: 1hour20minutes
measure: Score from a qualitative evaluation scale of the healthy voluntary discomfort during robot use and the score from a scale of the physician satisfaction (girth, ease, speed).
timeFrame: 1hour20minutes
measure: Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use
timeFrame: 1hour20minutes
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
state: Isère
Study officials:
affiliation: echipon@chu-grenoble.fr
name: Ivan Bricault, PhD, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05961241: Pelvic Floor Muscle Function Among Running Women
Official title: Pelvic Floor Muscle Function Among Running Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: Urinary incontinence
pelvic diaphragm
women's health
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups.
Primary purpose: SCREENING

Brief summary: This study will examine pelvic floor muscles function amongst women who run on a regular basis compared to controls. Women who do not run, will begin running protocol, and second evaluation will be performed following 2 months of training. Urinary incontinence will also be assessed.

Detailed description: The study will include women who have been running on a regular basis over two years, at least 3 times a week for half an hour (research group) and women who do not run at all (control group). The participants will answer a personal information questionnaire (including birth and exercise background), and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). Outcome measures will include an evaluation of the PFM function using Vaginal palpation and abdominal ultrasound examination.

Women who do not run at all, will begin running training protocol, and second evaluation will be performed following 2 months of training.

Eligibility criteria: Inclusion Criteria:

* at least six months after giving birth or who have not given birth at all, The running group will recruit healthy women who run at least 3 times a week, 30 minutes, for two consecutive years.

The control group will recruit healthy women who do not physical active on a daily basis

Exclusion Criteria:

* pregnancy
* grade 3 or higher of pelvic organ prolapse.

Primary outcomes:
measure: direction of urinary bladder displacement during contraction
timeFrame: baseline
measure: urinary bladder displacement in millimeters
timeFrame: baseline
measure: pelvic floor muscles endurance of contraction in seconds
timeFrame: baseline
measure: urinary incontinence
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Haifa University, Department of PHysical Therapy
Study officials:
affiliation: University of Haifa
name: Gali Dar, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00424541: Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension
Official title: A Multiple Center, Randomized, Double Blind, Parallel Group, Multiple Oral Doses Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profiles of 150 mg and 300 mg of SPP100 in Japanese Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Pharmacokinetics, pharmacodynamics, safety, RAS profile, SPP100, aliskiren, Japanese, essential hypertension
Mild to moderate essential hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate essential hypertension. Safety will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Japanese patients with mild to moderate essential hypertension aged 20 to 80 years
* Blood pressure: Mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:

  * 14 days before treatment: ≥ 90 mmHg and \< 110 mmHg
  * 3 days before treatment: ≥ 95 mmHg and \< 110 mmHg
  * The difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmHg
* Body weight no less than 50 kg

Exclusion Criteria:

* Patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmHg and/or mean diastolic blood pressure ≥ 110 mmHg at Day -28, Day -14 and Day -3.
* Patients with or suspected of having secondary hypertension
* Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28
Secondary outcomes:
measure: effect of aliskiren on the RAS profile
measure: relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren
measure: safety
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Investigative Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05194241: One MORE for Chronic Pain
Official title: Examining the Efficacy of a Single Session Mindfulness Oriented Recovery Enhancement Intervention: One MORE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be a single-site, two-arm randomized controlled trial conducted among chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually via a HIPAA compliant virtual meeting platform.


Eligibility criteria: Inclusion Criteria:

* men/women ≥18 years of age
* current chronic pain diagnosis
* reporting pain ≥3 on 0-10 scale

Exclusion Criteria:

* unstable illness judged by clinician to interfere with study participation

Primary outcomes:
measure: Pain Catastrophizing
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Secondary outcomes:
measure: Pain Intensity
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Pain Interference
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Other outcomes:
measure: Physical Function
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Sleep
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Depression
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Anxiety
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Prescription Pain Medication Misuse
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Trait Mindfulness
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Trait Self-Transcendence
timeFrame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
measure: Acute Pain
timeFrame: Will be completed immediately before and after the 2-hour, One MORE intervention.
measure: Decentering
timeFrame: Will be completed immediately before and after the 2-hour, One MORE intervention.
measure: Self-Transcendent State
timeFrame: Will be completed immediately before and after the 2-hour, One MORE intervention.
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT01760941: Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients
Official title: Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Symptomatic Osseous Bone Lesions From Any Malignancy
Keywords: Urology
Prostate
Breast
Lung
Chest
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400 flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative radiation therapy for patients with symptomatic bony metastatic disease who are currently enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize "standard of care" techniques.


Eligibility criteria: Inclusion Criteria:

* Symptomatic osseous bone lesion(s) from any malignancy, whether primary of metastatic, with histological confirmation of malignancy.
* Currently enrolled in hospice and referred for single fraction palliative radiotherapy.
* Performance status (to be evaluated by the radiation oncologist), Karnofsky Performance Scale ≥ 20 or ECOG Performance Scale \< 5 .
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Pregnancy.
* Unable to understand English.
* Unable to complete forms with assistance.
* Concurrent enrollment in a study of pain management involving medications or devices.

Primary outcomes:
measure: Feasibility of Treatment Delivery in the Same Day as Initial Evaluation
timeFrame: Up to 6 months
Secondary outcomes:
measure: Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction
timeFrame: 2 weeks
measure: Evaluate the Treatment Influence on Patient Quality of Life
timeFrame: 2 weeks
Other outcomes:
measure: Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile
timeFrame: 6 months
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Drew Moghanaki, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203541: Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
Official title: Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound Infection
Lead sponsor: Tyco Healthcare Group
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.


Eligibility criteria: Inclusion Criteria:

* Sign an informed consent form that has been approved by the Institutional Review Board.
* Adults at least 18 years of age.
* Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
* Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.

Exclusion Criteria:

* Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
* Be in need of a left ventricular assist device.
* Have an active pre-operative infectious process.
* Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).

Primary outcomes:
measure: Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
Secondary outcomes:
measure: Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Tyco Healthcare/Kendall
name: Katie Kavounis, MPH
role: STUDY_DIRECTOR
References: