louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01299025: Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
Official title: Balance Training for People With Multiple Sclerosis Using Nintendo Wii Fit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: balance
walking
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala-Örebro Regional Research Council
name: Norrbacka-Eugenia Foundation
First posted: 2011-02-18
Enrollment: 84
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 aim is to evaluate balance training using Nintendo Wii Fit. The hypothesis is that a period of training will increase balance capacity och self-efficacy.

People with diagnosed multiple sclerosis are invited to participate. Estimation of study power gave that 29 people in each group was necessary to detect a difference in the primary outcome measure, Timed Up and Go test.

Other measures used are the Four square step test, Dynamic Gait Index, Timed stands test, 25 foot walking test, 12-item Walking scale and the ABC scale.

Participants were randomised to either training or control. The training consisted of 6 weeks training with Nintendo Wii Fit 30 minutes 2 times a week.


Eligibility criteria: Inclusion Criteria:

* Diagnosed multiple sclerosis
* Subjective experience of affected balance and walking
* Being able to walk 100 meters with assistance

Exclusion Criteria:

* Cognitive or language deficits that prevents using the self-rating scales
* Visual deficits that prevents training with television games
* Weight above 149 kg

Primary outcomes:
measure: Change in Timed Up and Go Test From Day 1 to Day 42
timeFrame: Measured at day 1 (before the training period) and at day 42 (after the training period)
Secondary outcomes:
measure: Change in Score on the Dynamic Gait Index From Day 1 to Day 42
timeFrame: Measured at day 1 (before training) and day 42 (after training)
measure: Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42
timeFrame: Measured at day 1 (before training) and day 42 (after training)
measure: Change in the 12 Item Walking Scale From Day 1 to Day 42
timeFrame: Measured at day 1 and day 42, before and after the training
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
city: Karlstad
country: Sweden
facility: Karlstad hospital
city: Västerås
country: Sweden
facility: Västerås hospital
city: Örebro
country: Sweden
facility: Family Medicine Research centre
Study officials:
affiliation: Örebro County Council
name: Anette Forsberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02452125: The Effects of Nicotine Chewing Gum in Parkinson's Disease
Official title: The Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Blood Pressure
Parkinsons Disease
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this experiment is:

To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.

Detailed description: Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes.

After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicorette™). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of PD
* a diastolic BP less than 90 mmHg
* and/or a systolic BP lower than 100mHg.

Exclusion Criteria:

* current tobacco users in all forms of tobacco
* severe dysphasia (difficulty swallowing)
* previous tobacco users who might be at risk for re-addiction.

Primary outcomes:
measure: Blood Pressure
timeFrame: 90 minutes
Secondary outcomes:
measure: Heart Rate
timeFrame: 90 Minutes
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Joanne Donoghue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06759025: Chronic Neck Pain and Kinesiophobia
Official title: Relationship of Kinesiophobia with Clinical Outcomes in Individuals with Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Neck Pain
Keywords: chronic neck pain
kinesiophobia
quality of life
functionality
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the inclusion criteria and are receiving treatment at the Kırşehir Education and Research Hospital Physical Therapy and Rehabilitation Center will constitute the population.

Brief summary: In this study, the primary aim was to examine the relationship between kinesiophobia and clinical outcomes in individuals with chronic neck pain. The secondary aim was to compare the level of neck disability, pain, endurance, functionality, muscle and grip strength, and quality of life in individuals with chronic neck pain who had and did not have kinesiophobia; and to determine the determinants of kinesiophobia in patients with chronic neck pain.


Eligibility criteria: Inclusion Criteria:

* Neck pain complaints that have been ongoing for at least 3 months
* Between the ages of 18-65
* Complaints of numbness and tingling
* Volunteer who can cooperate during communication

Exclusion Criteria:

* History of spinal trauma or surgery
* Neurological, rheumatological, systemic or musculoskeletal problems that affect movement
* Serious comorbidities (such as advanced renal failure, previous history of CVA, malignancy)
* Muscle weakness

Primary outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: 24 weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 24 weeks
measure: Neck Disability Index
timeFrame: 24 weeks
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: 24 weeks
measure: SF-12 Quality of Life Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University
state: Merkez
Study officials:
References:
Clinical trial NCT03009825: Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients
Official title: TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Trauma exposure
Psychological distress
Emotion regulation
Mindfulness
Eating pathology
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: European Georges Pompidou Hospital
First posted: 2017-01-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity

Brief summary: The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.


Eligibility criteria: Inclusion Criteria:

* Adults
* Obese (BMI \>= 30)
* Recruited from the nutrition service of Hôpital Européen Georges-Pompidou
* Informed consent provided

Exclusion Criteria:

* PTSD symptoms (score \> 33 ; PTSD Checklist-5)
* Bariatric surgery patients
* Difficulties to understand French language
* Patients under social protection

Primary outcomes:
measure: Self-reported binge eating pathology (BES)
timeFrame: Baseline
Secondary outcomes:
measure: Self-reported anxiety and depression (HADS)
timeFrame: Baseline
measure: Self-reported mindfulness skills (FFMQ)
timeFrame: Baseline
measure: Self-reported emotion regulation (CERQ)
timeFrame: Baseline
measure: Self-reported eating patterns (TFEQ-R18)
timeFrame: Baseline
measure: Self-reported impact of traumatic event (IES-R)
timeFrame: Baseline
measure: Self-reported childhood trauma (CTQ)
timeFrame: Baseline
measure: Self-reported lifetime traumatic events (LEC-5)
timeFrame: Baseline
measure: Body Mass Index (kg/m2)
timeFrame: Baseline
Other outcomes:
measure: Sociodemographics and medical data
timeFrame: Baseline
Locations:
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
Study officials:
affiliation: University Paris 5 - Rene Descartes
name: Cécile Flahault, PhD
role: STUDY_DIRECTOR
affiliation: University Paris 5 - Rene Descartes
name: Sébastien Czernichow, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037725: Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
Official title: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
first time in human
food effect
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-12-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
* Healthy male and female volunteers. Females must be of non childbearing potential

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
* History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Primary outcomes:
measure: Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
timeFrame: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.
timeFrame: Samples taken during the residential period at defined timepoints pre-dose and post-dose.
measure: To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847
timeFrame: Samples taken during the residential period at defined timepoints pre-dose and post-dose
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Dr. Patricia A Meier, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01694225: Adherence Rate of Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
Official title: Estimating the Adherence Rate of a Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Anti-estrogen therapy
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2012-09-27
Enrollment: 87
Sex: FEMALE
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 study aims to establish the feasibility of using a monthly bubble package to improve compliance rates among women prescribed adjuvant endocrine therapy.

Detailed description: This study uses Bubble packaging to provide a cost effective way to improve compliance and help direct further interventions to ensure adherence in women on anti-estrogen therapy for breast cancer.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Estrogen receptor positive (\> 1% estrogen expression) by immunohistochemistry
* Invasive breast cancer (stage I, II, III) or DCIS considered for adjuvant endocrine therapy

Exclusion Criteria:

* Patients with metastatic disease (stage IV)
* Patients less than 18 years of age
* Prisoners
* Patients are unable to fill prescriptions at the BCC pharmacy due to insurance limitations or personal preference

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center-University of Louisville
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center- U of Louisville
name: Elizabeth C Riley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750125: Validation of Pulse Wave Doppler Demodulation Algorithm for the Continuous, Non-invasive Measurement of Blood Flow Velocity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus is on Healthy Subjects
Keywords: Doppler
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects 18-65

Brief summary: The investigators hypothesize that performance of fast-Fourier transformation on the raw Doppler signals obtained from ascending aortic blood flow will recreate the pulse wave Doppler trace visualized on modern echocardiography machines, and that this will allow for the measurement and recording of vascular flow waveforms

Detailed description: Currently there is no commercially available mechanism for the measurement of blood flow velocity waveforms non-invasively. Blood flow velocity waveforms require the use of invasive catheters, thus precluding clinical use. Such information would allow the researcher / practitioner the ability to continuously measure blood flow, pulse pressure, and the pulsatility index of any vascular structure accessible by ultrasound with minimal additional risk to the subject / patient. This data, when combined with arterial blood pressure data, could also be used to measure peripheral pressure volume loops as well as aortic vascular impedance, both of which cannot be currently measured in vivo.

The ability to measure blood flow velocity waveforms at high temporal resolution would provide clinicians with new tools for hemodynamic optimization (both a novel means of estimating myocardial oxygen consumption \[pressure volume area\] as well as afterload \[aortic vascular impedance\]) and researchers with the ability to conduct hemodynamic experiments that were not previously possible. This work will serve as the foundation for several other related projects which depend on the ability to continuously record blood flow velocity waveforms.

Eligibility criteria: Inclusion Criteria:

* 18-65
* Healthy

Exclusion Criteria:

* Cannot visualize ascending aorta with ultrasound

Primary outcomes:
measure: Comparison between estimated arterial flow waveform and pulse wave Doppler trace
timeFrame: day of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT06324825: Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
Official title: Fuzhegn Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia
Keywords: Atrophic Gastritis
Intraepithelial Neoplasia
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 144
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: Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule.


Eligibility criteria: Inclusion Criteria:

* Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia diagnosed by endoscopy and stomach biopsy.
* Helicobacter pylori negative.
* TCM syndrome is spleen-stomach deficiency with blood stasis and phelgm.

Exclusion Criteria:

* History of gastric surgery.
* Combined with malignant tumor.
* History of mental illness.
* Allergy to any components of the drug use in the study.
* Planning to pregnancy, or pregnant woman and lactating woman.

Primary outcomes:
measure: Recovery rate of Low-grade Intraepithelial Neoplasia
timeFrame: The 180 days after drug administration.
Secondary outcomes:
measure: 7-point Global Overall Symptom Scale
timeFrame: 1st, 2nd, 3rd, 4th, 5th, 6th month
measure: Adverse event rate
timeFrame: The 6 months during the drug administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04927325: Erythema at Exit Site & Tablet Camera
Official title: Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CLABSI - Central Line Associated Bloodstream Infection
CRBSI - Catheter Related Bloodstream Infection
Digital Technology
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 central lines with a reddened exit site 10 central lines without a reddened exit site
Primary purpose: OTHER

Brief summary: Background: In critical care medicine central venous catheters play an important role in the source of infections. In the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema, induration or tenderness. However, if an erythema at exit site of a central line can be quantified with a tablet camera, is unknown.

Methods: Standardized set of photos will be taken of 10 central lines with a reddened exit site and 10 catheters without an erythema (as a control over time) with a tablet camera and a single-lens reflex camera. The percentage of usable images between tablet and single-lens reflex camera will be analysed. Furthermore, two independent clinical experts from dermatology will grade blinded de-identied images on a scale from 0 to 4 (0 - no erythema, 1- very faint, 2 - faint, 3 - bright, 4 - very bright).

Objectives: The primary objective of this feasibility study aims to analyze the reliability of a tablet camera as a device for quantification of erythema around an exit site.


Eligibility criteria: Inclusion Criteria:

* Adult
* Jugular CVC or Subclavian CVC
* ICU-Admission

Exclusion Criteria:

* \< 18 years
* Pregnancy/Lactation
* HIV
* neutropenia (\<1000/m3)
* hematologic tumor
* dark pigmentation
* prone position within the last 24 hours
* head/neck-area: cancer, operation, burns or radiation, tattoos

Primary outcomes:
measure: Percentage of usable images
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Quantification of the exit site with regards to an erythema scale
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Department of Anaesthesia & General Intensive Care
role: STUDY_CHAIR
References: