louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04491292: Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce
Official title: Psychosocial Impact of COVID-19 Pandemic on MD Anderson Workforce
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Infection
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-29
Enrollment: 20000
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: Employees at MD Anderson Cancer Center.

Brief summary: This study investigates the impact of the COVID-19 pandemic on the psychosocial health of employees of MD Anderson Cancer Center. Epidemics have been shown to promote psychological stress among medical staff in high risk areas, which may lead to mental health problems. Assessing how the pandemic is affecting employees may allow for more comprehensive actions to be taken to protect the mental health of employees.

Detailed description: PRIMARY OBJECTIVE:

I. To assess psychosocial and stress-related outcomes in employees at MD Anderson Cancer Center during and post the COVID-19 pandemic.

SECONDARY OBJECTIVE:

I. To identify demographic and occupational factors associated with COVID-19 related psychosocial and stress outcomes.

OUTLINE:

Participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.

Eligibility criteria: Inclusion Criteria:

* MD Anderson employees

Primary outcomes:
measure: Change in psychosocial outcomes
timeFrame: Baseline up to 3 months after the outbreak ends
measure: Change in stress-related outcomes
timeFrame: Baseline up to 3 months after the outbreak ends
Secondary outcomes:
measure: Demographic and occupational factors associated psychological and stress-related outcomes
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priya R Bhosale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01965392: Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dependence, Dementias
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs.


Eligibility criteria: Inclusion Criteria:

* Primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. A dependent patient is understood to require the aid of someone else in order to carry out basic daily activities.

Exclusion Criteria:

* caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.

Primary outcomes:
measure: life quality
timeFrame: Data were evaluated with an average one month after discharge, a maximum in September 2009
Secondary outcomes:
measure: Caregiver´s burden
timeFrame: Data were evaluated with an average one month after discharge, a maximum in September 2009
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00765544: Targeted Lower Extremity Joint Training
Official title: Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: MS
Rehabilitation
Treadmill
Robot
Foot-drop
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The presence of foot drop limits normal gait. Our prior data has suggested that approximately 30% of MS patients have foot drop. Although we have observed that "task-specific" rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with "foot drop" have difficulty translating task-specific training to normative gait patterns over ground, despite improving speed and endurance.

One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential to address this. The device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the Anklebot alone does not train the knee or hip.

We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
2. Men and women between the ages 18-75 years.
3. Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
4. Must be able to ambulate 25 feet without an assisting device

Exclusion Criteria:

1. Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg, History of uncontrolled diabetes.
2. Symptoms of orthostasis when standing up.
3. Circulatory problems, history of vascular claudication or pitting edema.
4. Unable to fully understand instructions in order to use the equipment or the process of the study.
5. Body weight over 150 kg.
6. Lower extremity injuries that limit range of motion or function.
7. Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
8. Unstable fractures.
9. Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
10. Chronic and ongoing alcohol or drug abuse.
11. Pre-morbid, ongoing depression or psychosis.
12. Ongoing physical therapy.

Primary outcomes:
measure: Strength and Gait
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center
name: Albert Lo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113944: Training in the Workplace
Official title: Training in the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-04-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We are testing whether various cognitive training procedures can enhance cognition and brain function


Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 18-50 years old
* Right handed
* Must have reliable internet access from a desktop computer with webcam
* English speaking

Exclusion Criteria:

* Neurological conditions
* pregnancy
* metalic implants

Primary outcomes:
measure: MRI
timeFrame: 2 hours Pre and Post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusettts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069444: Comparison of the Effects of Truview Laryngoscopy and Macintosh Larygonscopy on Intubation Difficulty Score, Intubation Duration and Intubation Quality in Pediatric Patients Between 2-12 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All the Pediatric Patients Needed Intubation for Surgery
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients undergoing surgery which needs intubation

Brief summary: For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes. The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope in terms of intubation difficulty score, time to intubation and intubation quality score.


Eligibility criteria: Inclusion Criteria:

* aged 2-12 pediatric patients

Exclusion Criteria:

* any allergy
* difficult airway history

Primary outcomes:
measure: ease laryngoscopy in children
timeFrame: during laryngoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
city: Ankara
country: Turkey
facility: Ankara University, Pediatric Surgery
Study officials:
References:
Clinical trial NCT06021444: Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Pivotal, Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of 'DKM420' in Knee Osteoarthritis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Dongkook Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Parallel.
Primary purpose: TREATMENT

Brief summary: To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM 420 and control for patients who have osteoarthritis of Knee.

Detailed description: A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study

Eligibility criteria: Inclusion Criteria:

* Men and Women who is over 40 under 80 ages.
* Diagnosed as osteoarthritis of Knee and satisfies the 3 of 6 ACR(American College of Rheumatology) conditions.
* Kellgren Lawrence grade (Ⅰ\~Ⅲ) at Visit 1 or within 24 weeks.
* 100mm VAS(Visual Analogue Scale) over 40mm.
* Etc.

Exclusion Criteria:

- Pregnancy and lactating women

Primary outcomes:
measure: 100mm VAS(Visual Analogue Scale)
timeFrame: 16 weeks
Secondary outcomes:
measure: 100mm VAS(Visual Analogue Scale)
timeFrame: 2, 8 weeks
measure: K-WOMAC(Korean Western Ontario and McMaster Universities)
timeFrame: 2, 8, 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT03138044: Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma
Official title: Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Ipsilateral Liver Lobe Devascularization
Alcohol Treatment
CILDAT
Lead sponsor: The National Ribat University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized and time series clinical trial.
Primary purpose: TREATMENT

Brief summary: Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.

Detailed description: Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.

Eligibility criteria: Inclusion Criteria:

* Review and sign informed consent;
* Between 15 and 80 years of age at time of trial enrollment;
* Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
* Radiologically documented tumor size of \> 5 centimeters;
* Radiologically documented liver cirrhosis.

Exclusion Criteria:

* American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
* Uncontrollable ascites;
* Deep persistent jaundice;
* Hepatic encephalopathy;
* Coagulopathy;
* Severe uncorrectable thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;

Primary outcomes:
measure: Overall survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 3 years
measure: Major complications' rate
timeFrame: 3 years
measure: Major toxicity rate
timeFrame: 3 years
measure: Tumor response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Ribat University Hospital
Study officials:
affiliation: The National Ribat University
name: Osama M Elsanousi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsanousi OM, Mohamed MA, Salim FH, Adam EA, Bedri S. Long-term outcome of novel combined surgical-injection treatment (COSIT) for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Ann Med Surg (Lond). 2021 Nov 24;72:103098. doi: 10.1016/j.amsu.2021.103098. eCollection 2021 Dec.
Clinical trial NCT06651944: Invisalign® System with Mandibular Advancement
Official title: Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Class II Malocclusion
Mandibular Advancement
Mandibular Retrognathism
Excessive Overjet
Keywords: Class II Malocclusion
Mandibular Advancement
Invisalign
Orthodontics
Occlusal Blocks
Growing Patients
Lead sponsor: Align Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks


Eligibility criteria: Inclusion Criteria:

• Subject must be eligible for Invisalign treatment with mandibular advancement

Exclusion Criteria:

* Subject's dentition not compatible with device or allergy to device materials
* Subject who is pregnant, has active caries, periodontal disease, TMD, root resorption, has HAE (hereditary angioedema), has been diagnosed with epilepsy or any other seizure disorder

Primary outcomes:
measure: Comfort and fit
timeFrame: Through the study completion of up to 2 years
Secondary outcomes:
measure: Class II correction
timeFrame: Through the study completion of up to 2 years
Other outcomes:
measure: Class II correction
timeFrame: Through the study completion of up to 2 years
Locations:
city: Richmond
country: Canada
facility: Astra Orthodontics
state: British Columbia
city: Saint John
country: Canada
facility: MacKenzie Orthodontics
state: New Brunswick
city: Brampton
country: Canada
facility: Discover Orthodontics
state: Ontario
Study officials:
References:
Clinical trial NCT02861144: The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities
Official title: Partnerships for Cardiometabolic Disparities in Native and Pacific People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-08-10
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities is a randomized control trial that will test the effectiveness of partnership incentives plus evidence-based education to optimize glycemic outcomes among diabetic patients compared with usual care.

Detailed description: The Hanapū Study will use a block randomization study design to enroll 100 diabetic patients in each arm (n = 200) followed over 9 months. Providers will identify diabetic patients. After the baseline visit is completed, patient(s) and their provider will be randomized to either Intervention or Usual care arm as partners. The intervention arm will receive diabetes self-management education and modest financial incentives (gift cards) for completing diabetes process and glycemic outcomes according diabetes "best practices". Usual care patients will receive an equal number of educational materials on diabetes self-management via mail and will receive usual care through their provider but will not receive additional incentives for reaching glycemic outcomes. Both arms of the study will complete outcome visits at baseline, 4.5 and 9 months.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of diabetes mellitus
* HbA1c \>7%
* Not planning to move out of the State
* Able to fully participate in either intervention or usual care arms.

Exclusion Criteria:

* Pregnancy
* End Stage Renal Disease requiring dialysis
* Any medical condition that would prevent participation in all aspects of the study protocol (including major psychiatric diagnosis) or with \< 6 month expected survival, as determined by the patient's physician.

Primary outcomes:
measure: Change of HbA1c
timeFrame: Baseline, 4.5 months and 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hawaii
name: Marjorie K Mau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05845944: Video Education About Nasogastric Tube Feeding
Official title: Evaluation of the Efficiency of the Video-supported Education Given to Students for Nasogastric Tube Feeding in Pediatric Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Nurse's Role
Education
Pediatric
Keywords: Nursing students
Education
Pediatric patient
Nasogastric tube
Feeding
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Izmir Bakircay University
First posted: 2023-05-06
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research was a randomized controlled, experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Summary Aim: This research was conducted to determine the effectiveness of education given to students using video in feeding with the nasogastric tube for pediatric patients.

Method: It was a randomized controlled experimental study. The sample of the study consisted of 61 nursing students. The students included in the study were divided into two equal groups: the experimental and control groups. Video-supported education material of the experimental group and theoretical education was applied to the control group. Before and after the education, a post-knowledge test was made and evaluated.


Eligibility criteria: Inclusion Criteria:

* Being a student of the Department of Nursing
* Taking the child health and diseases nursing course and being successful
* Volunteering to participate in the research

Exclusion Criteria:

* Participate and quit the study
* Being a 1st and 2nd year nursing student
* Failure of the child health and diseases nursing course

Primary outcomes:
measure: Statistical difference between groups about knowledge test scores
timeFrame: During the education, approximately 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Bakırcay University
Study officials:
affiliation: Izmir Bakircay University
name: Ayşenur Atay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037044: The Effect of Sensory Integration Balance Training on Children With ABI
Official title: The Effect of Sensory Integration Balance Training Compared With Traditional Balance Training for Children With Acquired Brain Injury (ABI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Children With Acquired Brain Injury
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to investagte the effectivness of sensory integartion balance training during gait training with obstecles and stimulation to different sensation, in comparission to gait training with obstecles without sensory stimulation among children with acuired brain injury


Eligibility criteria: Inclusion Criteria:

* Children with ABI, able to walk with or without assistance, GMFCS level I-III, aged 4-12 years old, with subjective symptoms of balance impairments, fear of falling and/or history of falls

Exclusion Criteria:

* Botox injections or tendon release surgery in the past six months

Primary outcomes:
measure: Pediatric balance scale (PBS)
timeFrame: One week before and after training then one month after training
measure: Gross motor functional measure (GMFM)
timeFrame: One week before and after training then one month after training
measure: Timed up and go (TUG)
timeFrame: One week before and after training then one month after training
measure: Obstacle Test
timeFrame: One week before and after training then one month after training
Secondary outcomes:
measure: The Pediatric Quality of Life Inventory (PedsQL)
timeFrame: one week before and after training then one month after training
measure: One min sit to stand test (1-MSTST)
timeFrame: one week before and after training then one month after training
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King abdullah bin abdulaziz university hospital
Study officials:
References: