louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04375137: Correlation Between Oxidative Stress Status and COVID-19 Severity
Official title: Correlation Between Oxidative Stress Markers and COVID-19 Severity Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe COVID:Hypoxic intubated Non-severe COVID: non-hypoxic in ward Healthy Controls

Brief summary: During the new COVID-19 pandemic physicians all over the world have faced different challenges .Oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in COVID-19 infection to the best of knowledge.Present study aimed to evaluate oxidative stress marker and redox system status in different COVID-19 patients regarding the severity of involvement.

Detailed description: Oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in COVID-19 infection to the best of knowledge.Present study aimed to evaluate oxidative stress marker and redox system status in different COVID-19 patients regarding the severity of involvement. Demographic and lab data of 60 COVID-19 confirmed positive cases gathered .These patients divided in to two arms: 1- severe COVID-19 which were intubated or admitted in intensive care unit due to severe hypoxia 2- non-severe COVID-19 patients which were not hypoxic and admitted in ward with no need to invasive oxygenation. All patients had positive RT-PCR positive nasopharyngeal swab results for COVID-19 or Lung CT scan compatible with COVID-19. Malondialdehyde(MDA) , Biopterin, Neopterin, SOD, Glutathione levels would be checked by ELISA tests and compared between these two groups and healthy controls.

Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* positive RT-PCR COVID-19
* compatible lung CT with COVID-19

Exclusion Criteria:

* not signing informed consent
* using antioxidants
* using statins

Primary outcomes:
measure: MDA concentration
timeFrame: 2 weeks
Secondary outcomes:
measure: Biopterin concentration
timeFrame: 2 weeks
measure: Neopterin rate of increase
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: SBMU
name: Dalili
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587815: The Impact of a Musical Starry Sky Projector on Fatigue, Sleep, and Quality of Life in Pediatric Oncology Patients
Official title: The Effect of a Musical Starry Sky Projector on Fatigue, Sleep, and Quality of Life in Pediatric Oncology Patients: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Oncology
Sleep Problems
Fatigue Intensity
Quality of Life
Keywords: fatigue, pediatric oncology, sleep, quality of life
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluated the effect of an Ocean Wave and LED Starry Sky Projector on fatigue, sleep, and quality of life in pediatric oncology patients.

Detailed description: Sleep disturbances and fatigue were common issues among pediatric oncology patients, significantly impacting their overall quality of life. This study aimed to evaluate the effect of an Ocean Wave and LED Starry Sky Projector on fatigue, sleep patterns, and quality of life in this patient population. The research was structured as a parallel-group, randomized controlled trial. Pediatric oncology patients, aged 8-18 years, were recruited for participation.

The study intervention group used the Ocean Wave and LED Starry Sky Projector each night for one month, along with receiving the standard care typically provided in the oncology unit. The projector created a soothing visual and auditory environment designed to help induce relaxation, potentially improving sleep and reducing fatigue. Meanwhile, the control group received only the standard care offered to pediatric oncology patients, without the addition of the projector intervention. This study offered valuable insights into the use of non-pharmacological interventions for improving sleep quality and reducing fatigue among pediatric oncology patients.

Eligibility criteria: Inclusion Criteria:

* Pediatric oncology patients aged 8-18 years.
* Recently diagnosed (\&amp;lt; 1 month).
* Active receiving chemotherapy treatment
* Able to read and write in Turkish.
* Willing to participate voluntarily.

Exclusion Criteria:

* Being at the end of life
* Diagnosed with mental problems.
* Haemoglobin levels below 7 mg/dL).
* Having visual or hearing impairments.
* Unable to understand or communicate in Turkish.

Primary outcomes:
measure: Fatigue Intensity Scale Score
timeFrame: It will be evaluated every day for one month.
measure: Visual Sleep Scale Score
timeFrame: It will be evaluated every day for one month.
measure: Pediatric Quality of Life Inventory (PedsQL) Score
timeFrame: It will be evaluated every before the study and at the end of the first month.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
state: Fatih
Study officials:
References:
Clinical trial NCT03983915: Sedation Strategies for Therapeutic Bronchoscopy 2
Official title: Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchoscopy
Sedation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2019-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Scheduled for flexible therapeutic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts

Primary outcomes:
measure: Recovery time
timeFrame: After termination of the sedation medication, assessed up to 3 hours
Secondary outcomes:
measure: Satisfaction score of the patients and bronchoscopists
timeFrame: Across the procedure, assessed up to 3 hours
measure: Prevalence of the side effects of respiratory and circulatory system
timeFrame: Across the sedation or anesthesia, assessed up to 3 hours
measure: Cost of anesthesia or sedation
timeFrame: Across the sedation or anesthesia, assessed up to 3 hours
measure: Cough score
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
measure: The numbers of the times of body movement
timeFrame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Faculty of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01669915: A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Official title: A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-08-21
Enrollment: 3424
Sex: ALL
Minimum age (years): 60
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older participants of VITAL.

Detailed description: Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.

Eligibility criteria: Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:

1. are aged 60 or more
2. have no hearing impairment
3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.

Primary outcomes:
measure: Change in Global Composite Score for Cognitive Decline
timeFrame: Change over two assessments (baseline, 2.8 years).
Secondary outcomes:
measure: Change in Episodic Memory Score for Cognitive Decline
timeFrame: Change over two assessments (baseline, 2.8 years)
measure: Change in Executive Function Score for Cognitive Decline
timeFrame: Change over two assessments (baseline, 2.8 years)
measure: Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
timeFrame: Change over two assessments (baseline, 2.8 years)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Kang JH, Vyas CM, Okereke OI, Ogata S, Albert M, Lee IM, D'Agostino D, Buring JE, Cook NR, Grodstein F, Manson JE. Effect of vitamin D on cognitive decline: results from two ancillary studies of the VITAL randomized trial. Sci Rep. 2021 Dec 1;11(1):23253. doi: 10.1038/s41598-021-02485-8.
Clinical trial NCT03965715: An Ankle-foot Orthosis Improves Gait Performance and Satisfaction in Stroke Patients
Official title: Development of Energy-storable Ankle-foot Orthosis Using 3D Printing Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Analysis
Keywords: 3D printed technology
Ankle-Foot Orthosis (AFO)
Stroke
Gait parameters
Gait Analysis
kinetics
kinematics
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: All participants were at least 6-month post-stroke and had unilateral limb involvement (8 right/4 left). The main inclusion criteria in selection of the participants in this study were as follows :(1) First stroke (2) At least 6 months post stroke (3) Able to stand for at least one minute without any assistive devices (4) Able to walk for at least 10 meters. All participants were instructed to walk with bare foot or with ankle-foot orthoses(AFOs) separately under gait detection of the motion capture system. Participants were further instructed to complete the 10 Meter Walk Test at a comfortable speed with BF or with AFOs separately. All participants were provided with sufficient rest between each trial. Patient demographics such as lower limb Brunnstrom stage and Modified Ashworth Scale (MAS) score were examined and recorded by experienced therapist. The satisfaction and outcome were measured by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and SF-36. The kinematic and kinetic data were collected by Motion Analysis system.


Eligibility criteria: Inclusion Criteria:

* First stroke
* At least 6 months post-stroke
* Able to stand for at least one minute without any assistive devices
* Able to walk for at least 10 meters.

Exclusion Criteria:

* Unable to walk for at least 10 meters.

Primary outcomes:
measure: Kinematic analysis
timeFrame: Baseline
measure: 10 Meter Walk Test (10MWT)
timeFrame: Baseline
measure: Numerical rating scale
timeFrame: Baseline
measure: The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: Baseline
measure: 36-Item Short Form Survey (SF-36)
timeFrame: one month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
References:
Clinical trial NCT02176915: Trial of Fresh Start Weight Loss Intervention in WIC Participants
Official title: Fresh Start: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-06-27
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

Detailed description: The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.

Eligibility criteria: Inclusion Criteria:

* 6 months or less postpartum
* Speaks English
* BMI 25 or greater
* Client of WIC program, Worcester MA

Exclusion Criteria:

* Not able to give informed consent

Primary outcomes:
measure: Change in Body Mass Index from baseline
timeFrame: 3 months, 12 months
Secondary outcomes:
measure: Change in Pregnancy Physical Activity Questionnaire score from baseline
timeFrame: 3 months, 12 months
measure: Change in 24-hour dietary recall from baseline
timeFrame: 3 months, 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMass Worcester
name: Stephenie Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosal MC, Haughton CF, Estabrook BB, Wang ML, Chiriboga G, Nguyen OH, Person SD, Lemon SC. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial. BMC Public Health. 2016 Sep 9;16(1):953. doi: 10.1186/s12889-016-3520-0.
Clinical trial NCT01680315: Calorie Anticipation and Food Intake
Official title: Differences in Physiological Responses of Satiety and Reward After (in)Consistent Calorie Cues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behaviour
Obesity
Keywords: Satiety,
satiation,
anticipation,
food intake
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The regulation of our food intake is on the short-term guided by appetite and satiety signals generated by the sight and consumption of food. Food intake is not only regulated by appetite and satiety signals - external cues also play an important role.

It has been observed that food intake and the pleasure derived from consumption is affected by manipulation of the external cues.

The investigators will assess the contribution of food anticipation (calorie information) and actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin responses, appetite and subsequent food intake). The investigators expect the information on the amount of calories, rather than the actual amount of calories in the food, to predict the ghrelin responses and the subsequent intake of a second meal.

Detailed description: In a randomized cross-over design with 4 conditions, all participants will consume twice the low-caloric food (once with the low-calorie information and once with the high-calorie information) and twice the high-caloric food (again, once with the low-calorie information and once with the high-calorie information) in a randomized order.

Eligibility criteria: Inclusion Criteria:

* female
* healthy
* being used to eat breakfast regularly (≥ 5 times a week).

Exclusion Criteria:

* hypersensitivity for the ingredients of the foods under study;
* lack of appetite; following an energy-restricted diet or change in body weight \> 5 kg; or
* being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea.

Primary outcomes:
measure: Food intake
timeFrame: 60 min (Ad libitum test meal after 1 hr)
Secondary outcomes:
measure: Serum concentrations total ghrelin
timeFrame: 60 min (4 samples - every 20 min)
Other outcomes:
measure: appetite ratings
timeFrame: 80 min (5 samples - every 20 min)
measure: Serum cortisol concentrations
timeFrame: 60 min (4 samples - every 20 min)
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Pleunie Hogenkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hogenkamp PS, Cedernaes J, Chapman CD, Vogel H, Hjorth OC, Zarei S, Lundberg LS, Brooks SJ, Dickson SL, Benedict C, Schioth HB. Calorie anticipation alters food intake after low-caloric not high-caloric preloads. Obesity (Silver Spring). 2013 Aug;21(8):1548-53. doi: 10.1002/oby.20293. Epub 2013 Apr 13.
Clinical trial NCT06234215: Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia
Official title: Functional Task Training Combined With Electrical Stimulation on Balance and Motor Abilities in Children With Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the study are to:

1. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
2. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.

Detailed description: Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.

Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.

Eligibility criteria: Inclusion Criteria:

* Their ages will range from 7-11 years.
* Both genders will be included.
* Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
* Their motor function will be at level I \& II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
* They will be understanding instructions.

Exclusion Criteria:

* Children will be excluded from the study if they have any of the following criteria:

Musculoskeletal fixed deformities in upper limb, lower limb or spine.

* Visual or hearing problems.
* Epilepsy.
* Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.

Primary outcomes:
measure: Humac balance system
timeFrame: two months
Secondary outcomes:
measure: Growth motor functional scale
timeFrame: two months
Other outcomes:
Locations:
city: Ītāy Al Bārūd
country: Egypt
facility: ‪Randa Adel‬
state: El-beheira
Study officials:
affiliation: Cairo University
name: ‪Randa Adel‬, master
role: PRINCIPAL_INVESTIGATOR
References: