louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01736787: Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity
Keywords: Cauliflower Mushroom extract
immunity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT), and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 30-65 years old
* Weight within ±30% of ideal body weight
* Able to give informed consent

Exclusion Criteria:

* WBC concentration below 3000 ㎕
* Allergic or hypersensitive to any of the ingredients in the test products
* Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Cytotoxicity
timeFrame: 12 weeks
measure: Changes in Cytokine (IL-4, IL-10, IFN- γ, TNF-α)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT06268587: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery
Official title: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Outpatient Surgery
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 1423
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent outpatient surgery at the Liège university hospital center in Belgium

Brief summary: The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:

- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.

The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.


Eligibility criteria: Inclusion Criteria:

* outpatient surgery
* no age limit
* accepted post-operative monitoring by text messages (SMS)

Exclusion Criteria:

* refusal of post-operative follow-up by text messages (SMS)

Primary outcomes:
measure: Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics.
timeFrame: day 1
Secondary outcomes:
measure: Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group
timeFrame: day 1
measure: Measure the impact of the protocol on the occurrence of nausea and vomiting on day one
timeFrame: day 1
measure: Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction
timeFrame: day 7
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
state: Wallonie
Study officials:
References:
Clinical trial NCT03385187: Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Official title: Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Ectosense NV
Sponsor class: INDUSTRY
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2017-12-28
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.

Detailed description: The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

Eligibility criteria: Inclusion Criteria:

* Indication for a sleep study

Exclusion Criteria:

* Mentally disabled people
* Known allergy to Plexiglas (PMMA) or other acrylates

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: At the time of the diagnostic night
Secondary outcomes:
measure: Sleep-wake discrimination
timeFrame: At time of the diagnostic night
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ectosense NV
name: Duarte Mendes de Almeida, Ir.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03069287: Integrating Family Caregiver Support Into Cancer Clinical Trials
Official title: Feasibility and Acceptability of Integrating Family Caregiver Support Into Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Clinical Trials
Caregivers
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system.

Detailed description: The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system. This study will allow us to examine the benefit of adding a personalized support program for the family caregiver of a patients participating in a cancer clinical trial. Findings will assist in strengthening patient/caregiver-centered care management and support programs developed to enhance the quality of life of patients with cancer and the caregivers, reduce barriers to clinical recruitment, and improve retention in clinical trials.

Eligibility criteria: Inclusion Criteria:

* dyad must be at least 18 years of age,
* patient is enrolled or expressed intent to enroll in a therapeutic cancer clinical trial
* caregiver is a self-identified primary caregiver,
* able to speak, read, and understand English,
* willing to participate in completion of surveys, and
* co-residence

Primary outcomes:
measure: Absolute change in the Caregiver Reaction Assessment (CRA) score
timeFrame: 1 year
measure: Absolute change in the scores for the assessment domains included in the Ben Rose Institute (BRI) care consultation program
timeFrame: 1 year
Secondary outcomes:
measure: Absolute change in the Functional Assessment of Cancer Therapy - General (FACT-G) score
timeFrame: 1 year
measure: Absolute change in Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events (PRO-CTCAE) scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence Saint John's Health Center
state: California
Study officials:
References:
citation: Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.
citation: Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.
Clinical trial NCT02550587: Patient Satisfaction With Anesthesia Care
Official title: Satisfaction Rate of Patients Receiving Anesthesia in the First Half of 2015, in Erzincan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: Patient Satisfaction
anesthesia Care
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Erzincan University
First posted: 2015-09-15
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing anesthesia in Erzincan

Brief summary: The level of patient satisfaction is an important indicator of health care quality because it causes to reconsider the functioning of the hospital and go to the new regulations. Postoperative thought gives us important information for improving the quality of anesthesia care and health care quality. The investigators aimed to investigate the status of the anesthesia satisfaction in patients.

Detailed description: Patients will answer the questionnaire consisting of 15 questions

Eligibility criteria: Inclusion Criteria:

* Patients undergoing anesthesia
* between 18 - 65 years old
* to agree to participate in research
* undergo elective surgery

Exclusion Criteria:

* be a psychiatric disorder
* cardiovascular surgery
* Emergency surgery
* patients with speech-hearing problems

Primary outcomes:
measure: anesthesia satisfaction rates
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Üniversity
Study officials:
References:
citation: Fung D, Cohen MM. Measuring patient satisfaction with anesthesia care: a review of current methodology. Anesth Analg. 1998 Nov;87(5):1089-98. doi: 10.1097/00000539-199811000-00020. No abstract available.
citation: Eberhart LH, Morin AM, Wulf H, Geldner G. Patient preferences for immediate postoperative recovery. Br J Anaesth. 2002 Nov;89(5):760-1.
citation: Jenkins K, Grady D, Wong J, Correa R, Armanious S, Chung F. Post-operative recovery: day surgery patients' preferences. Br J Anaesth. 2001 Feb;86(2):272-4. doi: 10.1093/bja/86.2.272.
citation: Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
citation: Mathur SK, Dube SK, Jain S. Knowledge about Anaesthesia and Anaesthesiologist Amongst General Population in India. Indian J Anaesth. 2009 Apr;53(2):179-86.
citation: Demir A, Turan S, Balaban F, Karadeniz Ü, Erdemli Ö. Anestezi Uygulamaları ile İlgili Olarak Preanestezik Değerlendirme Sırasında Hastalarda Yapılan Anket Çalışması. Türk Anest Der Dergisi 2009;37:225-33
Clinical trial NCT05856487: To Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiovascular Diseases
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 228
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety NVP-2203 in patients

Detailed description: This study is a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial to evaluate efficacy and safety of NVP-2203 in patients

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 19 years of age
* Primary hypercholesterolemia
* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* The subject not meet the specified LDL-C level
* Patients who were diagnosed with a malignant tumor within five years before Visit
* Inadequate subject for the clinical trial by the investigator's decision

Primary outcomes:
measure: % change in LDL-C level from baseline
timeFrame: Week 8
Secondary outcomes:
measure: % change in lipid panel from baseline
timeFrame: Week 4, 8
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: NVPhealthcare
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: SH Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319787: Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer
Official title: A Randomized Placebo Controlled Study to Assess the Rate of PSA Decrease, Anatomical & Metabolic Changes in the Prostate Determined by MRI/3D-MRS & Histological Changes by Biopsy in Subjects With Locally Advanced Prostate Carcinoma Treated With Either Casodex® (Bicalutamide) Alone or the Combination of Casodex® & ZD1839 (Iressa™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma

Exclusion Criteria:

* No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding.

Primary outcomes:
measure: Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Secondary outcomes:
measure: To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)
measure: To detect changes in prostate gland using magnetic resonance imaging (MRI)
measure: To detect changes in serum tumor markers
measure: To assess histopathological changes
Other outcomes:
Locations:
city: Moelv
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
Study officials:
affiliation: AstraZeneca AS
name: AstraZeneca Norway Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02195687: BOTOX® in the Treatment of Crow's Feet Lines in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lateral Canthal Lines
Crow's Feet Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 417
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: This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).


Eligibility criteria: Inclusion Criteria:

-Moderate to severe Crow's Feet Lines.

Exclusion Criteria:

* Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
* Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
* Any medium-depth or deep facial peels within 5 years
* Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.

Primary outcomes:
measure: Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
timeFrame: Day 30
measure: Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
timeFrame: Day 30
measure: Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
timeFrame: Day 30
measure: Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
timeFrame: Baseline, Day 30
measure: Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
timeFrame: Day 30
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wu Y, Li C, Garcia J, Baradaran S. Patient-reported Outcomes in Chinese Subjects Treated with OnabotulinumtoxinA for Crow's Feet Lines. J Clin Aesthet Dermatol. 2021 Oct;14(10):27-31.
Clinical trial NCT03708887: The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients
Official title: Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycaemia (Diabetic)
Hyperlipidemias
Keywords: Type 2 diabetes
Obesity
Omega-3 fatty acids
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 415
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind and placebo-controlled study is conducted in the current human study.

The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.

Detailed description: Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.

Eligibility criteria: Inclusion Criteria:

* Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
* BMI≥28 for obese groups;
* Aged between 40 and 75 years.

Exclusion Criteria:

* Type 1 diabetes;
* Cardiovascular disease;
* Cancer;
* Liver or kidney disease;
* Premenopausal women, pregnancy or lactation;
* Allergy to fish;
* Have participated in other clinical trials in the last three months.

Primary outcomes:
measure: Change in blood glucose from baseline
timeFrame: 12 months
measure: Change in blood lipids from baseline
timeFrame: 12 months
measure: Change in carotid plaque and carotid intima-meida thickness
timeFrame: 12 months
Secondary outcomes:
measure: Change in gut microbiota from baseline
timeFrame: 12 months
measure: Change in sleep quality
timeFrame: 12 months
measure: Change in cognitive function
timeFrame: 12 months
measure: Change in bone mineral density (BMD)
timeFrame: 12 months
measure: Change in body fat distribution
timeFrame: 12 months
measure: Change in urinary protein concentration
timeFrame: 12 months
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: 12 months
measure: Change in blood metabolome
timeFrame: 12 months
Other outcomes:
measure: Change in fecal metabolome
timeFrame: 12 months
measure: Change in urine metabolome
timeFrame: 12 months
Locations:
city: Jinhua
country: China
facility: Lanxi Red Cross Hospital
state: Zhejiang
Study officials:
References: