louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03128931: SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
Official title: SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.


Eligibility criteria: Inclusion Criteria:

* Patients 17 years old and younger
* ASA status I, II, or III.
* Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic).

Exclusion Criteria:

* Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit.
* Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions).
* Subjects who are developmentally delayed.
* Subjects deemed not suitable for study at the discretion of the investigator.

Primary outcomes:
measure: Number of Participants For Whom the EEG Data Collection Was Completed
timeFrame: Duration of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT01237431: Importance of Liver Innervation for the Osmopressor Response in Humans
Official title: Importance of Liver Innervation for the Osmopressor Response in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PHYSIOLOGICAL PHENOMENA
Keywords: Water drinking
osmoreceptors
autonomic failure
syncope
blood pressure
liver transplant
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In patients with autonomic dysfunction water drinking elicits a pressor response mediated by sympathetic activation. If any, in healthy subjects there is only a slight increase in blood pressure. However, the sympathetic activation is observable by resting energy expenditure increases greater than 20%.

The investigators believe that the response to water may be mediated through sympathetic activation elicited by osmosensitve spinal afferents in the liver. Therefore, the investigators want to test water in liver transplant patients who have a denervated liver. Kidney transplant patients serve as control subjects. The investigators hypothesize that the increase in norepinephrine after water drinking is blunted in liver transplant recipients.


Eligibility criteria: Inclusion Criteria:

* 3 to 24 month past liver or kidney transplantation
* age 18 to 60
* written informed consent
* ability to understand the oral and written information

Exclusion Criteria:

* pregnancy or lactation
* transplantation of another organ
* chronic heart or vascular disease
* known alcohol or drug abuse
* psychiatric diseases (e.g. chronic depression, schizophrenia, drug addiction)

Primary outcomes:
measure: norepinephrine plasma level
timeFrame: 30-40 minutes after water drinking
Secondary outcomes:
measure: pressure response
timeFrame: blood pressure 30-40 minutes after water drinking
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: NDS
Study officials:
References:
citation: May M, Gueler F, Barg-Hock H, Heiringhoff KH, Engeli S, Heusser K, Diedrich A, Brandt A, Strassburg CP, Tank J, Sweep FC, Jordan J. Liver afferents contribute to water drinking-induced sympathetic activation in human subjects: a clinical trial. PLoS One. 2011;6(10):e25898. doi: 10.1371/journal.pone.0025898. Epub 2011 Oct 7.
Clinical trial NCT02166931: BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
Official title: The Effectiveness of BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Associated Cognitive Inhibition
Essence of Chicken
Cognition
Immunity
Metabolism
Keywords: Essence of Chicken
stress
cognitive function
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective in the promotion of resilience and resistance to stress-associated cognitive inhibition.

Detailed description: This is a placebo-controlled, randomized, double-blind trial. There will be 100 subjects. Subjects are randomly assigned into either placebo or BRAND'S® Essence of Chicken (BEC), 70cc daily for 2 weeks, group.

Stress test, cognitive function assessment and blood tests will be carried out at Week 0, Week 2, and Week 4 (2 weeks after termination of supplementation).

The primary end-point is the better improvement of cognitive function after supplement with BEC than placebo. The second endpoints include improvement of global health survey and changes of biomarkers related to stress and immunity.

Eligibility criteria: Inclusion Criteria:

* aged over 20 years,
* mildly stressed with Perceive Stress Scale (PSS) score higher than 25
* All the participants should not require medication for their mood disturbance affected by stress during the trial.

Exclusion Criteria:

* history of chronic diseases
* any psychiatric or neurological diseases (e.g. depression)
* other medical illnesses (e.g. stroke, diabetes, other cardiovascular diseases)
* allergy history to chicken

Primary outcomes:
measure: Change from baseline in cognitive function at week 2 and week 4
timeFrame: baseline, week 2, week 4
Secondary outcomes:
measure: Change from baseline in biomarkers and and immunity related to stress at week 2 and week 4
timeFrame: baseline, week 2, week 4
Other outcomes:
measure: Change from baseline in global health survey at week 2 and week 4
timeFrame: baseline, week 2, week 4
Locations:
city: New Taipei
country: Taiwan
facility: Shuang Ho Hospital, Taipei medical University
Study officials:
affiliation: Neurology, Shuang Ho Hospital, Taipei Meidcal University, New Taipei City, Taiwan
name: Chaur-Jong Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172231: Effects of Instrument Assisted Soft Tissue Mobilization in Addition to Conventional Physiotherapy in Knee Arthrofibrosis
Official title: Effects of Instrument Assisted Soft Tissue Mobilization in Addition to Conventional Physiotherapy in Knee Arthrofibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthrofibrosis
Keywords: Knee, Arthrofibrosis,IASTM Instrument Assisted Soft Tissue Mobilization,range of motion
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both group will be recruited concurrently. Both group will receive treatment.
Primary purpose: TREATMENT

Brief summary: Arthrofibrosis is the abnormal proliferation of fibrous tissue within a joint and around the joint that leads to loss of motion, pain, muscle weakness, swelling, functional limitation. Study conducted to determine additional effects of IASTM along with conventional physiotherapy as compared to conventional physiotherapy alone on Range of motion, functional limitation and pain in knee arthrofibrosis.

Detailed description: Arthrofibrosis is common condition after surgeries, most of the arthrofibrosis literature addresses arthrofibrosis after arthroplasty or ligamentous reconstruction, and it is replete with manipulation under anesthesia or with arthroscopic interventions or both. Study will be conducted over period of 1 year at fauji foundation hospital.Ethical approval from ERC foundation university medical college. Participants recruited and written inform consent, following which they will be required to complete a self-reported demographic form. The data will be entered and analyzed on SPSS 22. IASTM is simple and effective intervention to improve Rom and functional limitation in patients with knee arthrofibrosis

Eligibility criteria: Inclusion Criteria:

* post Total knee replacement patients
* Extension lag \>10
* Flexion deficit \>25
* Age 18_60
* both male and female
* Numeric pain rating scale between 3-5

Exclusion Criteria:

* skin allergy
* Diabetic patient
* Any vascular disease
* Prolonged use of Corticosteroids
* Any infective or active inflammatory condition
* Fracture or dislocation
* Lower extremity functional scale score above 71.

Primary outcomes:
measure: Lower Extremity Functional Scale
timeFrame: 4 weeks
measure: Knee range of motion
timeFrame: 4 weeks
measure: pain intensity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT01126931: Wormwood in Chronic Progressive Disorders With Reduced Appetite
Official title: Pilot Trial With Wormwood to Improve Appetite in Cancer, Autoimmune Diseases, Depression and Old Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Crohn disease
Involuntary weight loss in cancer
IgA nephropathy
Depression with reduced appetite
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with reduced appetite and reduced quality of life as a result of chronic progressive disorders such as cancer, autoimmune diseases (Crohn, IgA-Nephropathy), old age and depression

Brief summary: Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders such as old age, immune disorders and cancer.

Trial aims at observing beneficial effects of wormwood supplementation in various chronic disorders associated with reduced appetite

Detailed description: Supplementation with wormwood in chronic disorders associated with reduced appetite.

Examples:

1. Cancer
2. Autoimmune diseases such as Crohns disease and IgA Nephropathy
3. Old age
4. Chronic stress and depression

Eligibility criteria: Inclusion Criteria:

* Appetite and weight loss
* Chronic progressive disease

Exclusion Criteria:

* Life expectancy less than 3 months

Primary outcomes:
measure: Improvement in appetite
timeFrame: 6-12 months
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University of Freiburg, Medical Faculty
state: Baden
Study officials:
affiliation: University of Freiburg, Nuclear Medicine, Germany
name: Simone S Krebs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omer B, Krebs S, Omer H, Noor TO. Steroid-sparing effect of wormwood (Artemisia absinthium) in Crohn's disease: a double-blind placebo-controlled study. Phytomedicine. 2007 Feb;14(2-3):87-95. doi: 10.1016/j.phymed.2007.01.001. Epub 2007 Jan 19.
citation: Krebs S, Omer TN, Omer B. Wormwood (Artemisia absinthium) suppresses tumour necrosis factor alpha and accelerates healing in patients with Crohn's disease - A controlled clinical trial. Phytomedicine. 2010 Apr;17(5):305-9. doi: 10.1016/j.phymed.2009.10.013. Epub 2009 Dec 3.
citation: Krebs S, Omer B, Omer TN, Fliser D. Wormwood (Artemisia absinthium) for poorly responsive early-stage IgA nephropathy: a pilot uncontrolled trial. Am J Kidney Dis. 2010 Dec;56(6):1095-9. doi: 10.1053/j.ajkd.2010.06.025. Epub 2010 Sep 16.
Clinical trial NCT01423331: An Evaluation and Factor Analysis for Maternal Mental Health
Official title: An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the Shin Kong Wu Ho-Su Memorial Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Depression
Keywords: Postpartum depression
maternal mental health
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2011-08-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: the pregnant women or mothers within six months after birth

Brief summary: An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the Shin Kong Wu Ho-Su Memorial Hospital

- Objectives：

1. To construct a screening tool for domestic maternal mental health
2. To expect to find the screening timing for early assessment or intervention of domestic maternal mental health status.
3. To explore the impact of domestic maternal mental health factors.

Detailed description: -Study Design： This project will be conducted at the Shin Kong Memorial Hospital for pregnant women or mothers within six months after birth, with the base of existing domestic and foreign screening tools for postpartum depression and the related scale modeled, and select respective women during different pregnant period and after birth as postpartum study, by longitudinal study and cross-sectional study of the advantages to be able to plan time for up to twelve months of data collection, able to undertake within-subjects comparison and the between-subjects comparison, to view depression during pregnancy , pregnancy depression, postpartum blues, postpartum depression, postpartum psychosis such as prevalence, risk factors or any other factors.

To establish the screening tool and screening time for national early assessment of maternal mental health status of women in pregnancy and after birth.

-Effect：

1. Expected to construct the applicable domestic early assessment screening or intervention time of maternal mental health status.
2. Expected to develop different screening tools for a domestic early assessment of the maternal mental health status.
3. Expected to identify the important factors of maternal depression to provide a reference for locking in a high risk group for early intervention.
4. The implementation of women's health policy on mental health care of pregnant women with specific feasible approach.
5. To provide mental health counseling, the implementation of the operation of the network of community resources to reduce maternal stress in coping to new life.

Eligibility criteria: Inclusion Criteria:

* the pregnant women or mothers within six months after birth

Exclusion Criteria:

* Minor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Yieh-Loong Tsai
role: STUDY_CHAIR
References:
Clinical trial NCT06078631: Influence of Students Behaviors on Performance and Quality of Life on the OSCE
Official title: Influence of Students Behaviors on Thier Performance and Quality of Life on the OSCE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Objective Structured Clinical Examination
Performance Anxiety
Keywords: stress
physical activity
sedentarity
sleep
quality of life
coping
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students

Brief summary: The students behave differentially before an exam. This study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their OSCE.

Detailed description: The students behave differentially before an exam. They can be discriminate, on their sleeping, coping, or physical activity behavior. They also show difference in the number of hours they study by weeks or if they use the services offer by their university.

This study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their OSCE (a major exam).

Eligibility criteria: Inclusion Criteria:

* all volontary medical students of the third cycle that came for their exam during the sessions of December and May 2023 from the University of Lyon (Medecine ESt)

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: PERFORMANCE
timeFrame: obtained 7 days after the OSCE
Secondary outcomes:
measure: SF-12
timeFrame: obtained one hour after the OSCE
Other outcomes:
Locations:
city: Lyon
country: France
facility: Marc lilot
Study officials:
affiliation: UCBL1
name: Gilles Rode, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01405131: A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
Official title: Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Therapeutic Equivalency
Keywords: bioequivalence study
methylprednisolone
suspension
tablets
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 45 kg (99 lbs).

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen

Primary outcomes:
measure: AUCinf (area under the concentration curve to infinity)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Cmax (maximum concentration)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary outcomes:
measure: AUC last (area under the concentration curve to last time point)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Tmax (time at maximum concentration)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Half-life
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03868631: Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements
Official title: Muscle Growth and Development Following a 12-week Resistance Training Program in Men and Women Consuming Soy and Whey Protein Supplements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Muscle Growth
Lead sponsor: Point Loma Nazarene University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Soy and whey protein have different concentrations of leucine, an amino acid known to be a particularly potent simulator of muscle protein synthesis. The purpose of this study is to determine whether matching soy and whey protein supplements for leucine content instead of by total protein content would contribute to differences in strength increases and muscle growth in response to 12 wk of resistance training.


Eligibility criteria: Inclusion Criteria:

* non-smoking
* body mass index (BMI) 18.5-24.9
* recreationally active

Exclusion Criteria:

* participated in structured weight training during the previous 12 month
* vegetarian or vegan
* presence of chronic disease
* pregnant, postpartum up to six months, lactating, or intention to become pregnant
* allergy to whey or soy
* changes in body weight more than 10 pounds in the past three months

Primary outcomes:
measure: Lean Body Mass Change
timeFrame: Post-12 week intervention
measure: Muscle Tissue Thickness Change
timeFrame: Post-12 week intervention
measure: Leg Girth Changes
timeFrame: Post-12 week intervention
Secondary outcomes:
measure: Change in Peak Torque When Doing Leg Extensions
timeFrame: Post-12 week intervention
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Point Loma Nazarene University
name: Heidi Lynch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699382: Improvement Mental Health Among Physicians by a Mindfulness-training Mobile Application
Official title: Improvement in Mental Health Markers Among Hospital Physicians Through a Mindfulness-training Mobile Application - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of our study was to evaluate the effect of a short, smartphone-based mindfulness application on stress, wellbeing and burnout among hospital physicians

Detailed description: Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks and a control group (CG). Main Measures: All participants filled-out questionnaires assessing stress (Perceived Stress Scale-PSS), mental health (Mental Health Inventory-MHI) and burnout (Maslach Burnout Inventory-MBI) at baseline and 7 weeks later

Eligibility criteria: Inclusion Criteria:

\* Physicians Working full-time at the Rambam Healthcare Campus.

Exclusion Criteria:

\* Physicians that won't be able to participate in at least 50% of the practicing.

Primary outcomes:
measure: Perceived Stress Scale-PSS
timeFrame: 7 weeks
Secondary outcomes:
measure: Mental Health Inventory-MHI
timeFrame: 7 weeks
measure: Maslach Burnout Inventory - MBI
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Pediatric rheumatology clinic, Rambam Medical Center
Study officials:
affiliation: Rambam
name: Yonatan Butbul
role: PRINCIPAL_INVESTIGATOR
References: