louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01684371: The Effects of Elmore Oil on Patients With Osteoarthritis
Official title: The Effects of a Herbal Remedy, Elmore Oil, on Pain and Well-being in Patients With Osteoarthritis: A Double-blind, Placebo-controlled, Randomised Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Arthritis
Inflammation
Keywords: Osteoarthritis
Osteoarthritic pain
Arthritic pain
Arthritis
joint inflammation
Arthralgia
Lead sponsor: Elmore Oil Company Pty Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population from which the cohorts will be selected are from hospital primary care arthritis clinic.

Brief summary: The treatment of osteoarthritis, a disease that eventually affects the majority of the older population, involves the alleviation of symptoms such as pain and stiffness, and the reduction of inflammation. A double-blind, placebo-controlled, crossover study will be performed to examine the effect of topical application of Elmore Oil, a herbal remedy (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.

Detailed description: Sixty patients were randomly selected and approved for the study, 30 patients with even numbers received the blue dotted Elmore oil and 30 patients with odd numbers got the orange dotted Elmore and were advised to apply 3x daily on the affected knees respectively for four weeks. On the fifth week, they stopped application for 7 days as flush out period. Then on the 6th week a cross over was done on the patients - the blue dotted patients, this time received the orange dotted Elmore Oil and vice-versa and did the application three times daily for another 4 weeks. All throughout the usage, they filled out their diaries (noting the degree of pain, feeling of well being (improved sleep, mobility, ability to do their daily activities at home or at work). A pre-application base line laboratory tests were done, after 4 weeks and after 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosed osteoarthritis based on the criteria developed by the American College of Rheumatology.

Exclusion Criteria:

* Using other forms of topical pain relief.

Primary outcomes:
measure: Decrease in joint swelling, pain and stiffness after each treatment period
timeFrame: Every day for 28 days
Secondary outcomes:
measure: Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.
timeFrame: 28 days
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Centre
state: Manila
Study officials:
affiliation: Veterans Memorial Medical Centre
name: Letitia Lucero, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03722771: Influence of Lavender Oil on Vital Signs in Oral Surgery Patients
Official title: Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Sedative; Anxiety Disorder
Keywords: Lavandula
phytotherapy
aromatherapy
dental anxiety
anaesthesia
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients.

Detailed description: Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the greatest concern among dental practices for patients. Limited randomized clinical trials have demonstrated evidence-based results of lavender oil, despite being the most effective essential oil for anxiety and stress. The hypothesis of the present study was that the inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and consequently may effect intra and post-operative blood pressure, inspiration and heart rate.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of wisdom tooth
* Must be similar in age-height-weight
* Must be similar socio-culturally

Exclusion Criteria:

* Under 18 years of age
* Taking psychotropic medication or psychiatric treatment
* Systemically unhealthy patients
* Pregnants

Primary outcomes:
measure: Vital Sign Measurements - 1 - changes in blood pressure
timeFrame: through study completion an average of 3 months
measure: Vital Sign Measurements - 2 - changes in respiratory rate
timeFrame: through study completion an average of 3 months
measure: Vital Sign Measurements - 3 - changes in heart rate
timeFrame: through study completion an average of 3 months
measure: Vital Sign Measurements - 4 - changes in saturation level
timeFrame: through study completion an average of 3 months
Secondary outcomes:
measure: Anxiety Test 1 - MDAS tests
timeFrame: through study completion an average of 3 months
measure: Anxiety Test 2 - STAI-S tests
timeFrame: through study completion an average of 3 months
Other outcomes:
Locations:
city: Ri̇ze
country: Turkey
facility: Nazife Begüm KARAN
state: Merkez
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Nazife Begüm KARAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
Clinical trial NCT05031871: Pharmacokinetics of HR17031 Injection in Healthy Subjects
Official title: Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ranges from 18 to 27 kg/m2 (both ends included), and the body weight is ≥50 kg for men and ≥45 kg for women；
2. Fasting blood glucose during the screening is \< 6.1 mmol/L；

Exclusion Criteria:

1. It has clinical significance for abnormalities Laboratory examination, if there is a clear reasonable reason, can be retested within a week, with the retest results Whether the subject meets the requirements
2. Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening;
3. Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)

Primary outcomes:
measure: Cmax：Maximum observed concentration
timeFrame: Day1 to Day 26
measure: AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；
timeFrame: Day1 to Day 26
measure: AUC0-inf：Area under the curve from time 0 to infinity；
timeFrame: Day1 to Day 26
Secondary outcomes:
measure: Tmax ：time of maximum observed concentration
timeFrame: Day1 to Day 26
measure: T1/2：Half-life time ；
timeFrame: Day1 to Day 26
measure: CL/F
timeFrame: Day1 to Day 26
measure: Vz/F
timeFrame: Day1 to Day 26
measure: Serum glucose within 24h after injection
timeFrame: Day1 to Day 23
measure: C-peptide concentrations within 24h after injection
timeFrame: Day1 to Day 23
measure: ADA：anti-drug antibody
timeFrame: Day 1、Day 8、Day15、Day 22 or early termination
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01166971: A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Official title: A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: presbyopia
intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.


Eligibility criteria: Inclusion Criteria:

* diagnosed with bilateral cataracts
* candidate for presbyopic lens

Exclusion Criteria:

* \>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
* pre-existing conditions that could skew the results

Primary outcomes:
measure: Defocus Curve
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Panama City
country: United States
facility: The Eye Center of North Florida
state: Florida
city: Charleston
country: United States
facility: Carolina Eye Care Physicians
state: South Carolina
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
Study officials:
References:
Clinical trial NCT01842971: ALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis
Official title: Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: two stage hepatectomy
liver metastasis
colorectal cancer
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.

Detailed description: In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis.

In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed.

An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.

Eligibility criteria: Inclusion Criteria:

* potentially resectable liver metastasis from colorectal cancer
* portal embolisation required
* older than 18 years old

Exclusion Criteria:

* synchronous surgery on the colon or the rectum
* extra hepatic metastasis
* history of hepatectomy
* pregnancy or breastfeeding

Primary outcomes:
measure: number of complete surgical procedure
timeFrame: postoperative week 4
Secondary outcomes:
measure: overall mortality
timeFrame: one year after the two stage hepatectomy
measure: number of patient with hepatocellular insufficiency
timeFrame: postoperative day 30
measure: overall morbidity
timeFrame: postoperative day 30
measure: preoperative liver volumetry
timeFrame: one week prior to the surgery
measure: quality of life
timeFrame: the day before the first stage surgery and the day before the second stage surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
Study officials:
affiliation: Amiens University Hospital
name: jean marc regimbeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03561571: Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes
Official title: Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: chylomicrons
Very Low Density Lipoprotein
saturated fat
platelet function
type 2 diabetes
post prandial phase
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 32
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate in vitro the effect of triglyceride rich lipoproteins (TGRL) obtained in type 2 diabetic women in the fasting state and following a randomized isocaloric lipid rich breakfast on control human platelets

Randomized Comparison of butter versus chocolate spread in 2 groups of 15 patients


Eligibility criteria: Inclusion Criteria:

* Menopausal women
* HbA1c ≥6,5 ou ≤10%
* 27 ≤ BMI ≤40 kg/m2

Exclusion Criteria:

* Insulin therapy
* fibrates or Omega 3 fatty acids supplements
* Hormonal replacement therapy of menopause
* Glycemia \> 16 mmol/l
* Alcohol abuse (≥3 Unit/day)
* Special dietary habits
* History of bariatric surgery

Primary outcomes:
measure: fasting thromboxane B2 concentration
timeFrame: Hour 0
measure: after breakfast thromboxane B2 concentration
timeFrame: 4 hours
Secondary outcomes:
measure: measurement of fasting platelet activation by turbidimetric method
timeFrame: Hour 0
measure: measurement of post prandial platelet activation by turbidimetric method
timeFrame: 4 Hours
measure: fasting lipidomic composition of triglyceride rich lipoproteins
timeFrame: Hour 0
measure: post prandial lipidomic composition of triglyceride rich lipoproteins
timeFrame: 4 Hours
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel - department of endocrinology
Study officials:
References:
Clinical trial NCT01412671: Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
Official title: Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Nexavar
unresectable or advanced renal cell carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who received Nexavar for unresectable or advanced RCC.

Brief summary: This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.


Eligibility criteria: Inclusion Criteria:

* Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
timeFrame: After Nexavar administration, up to 1 year
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, clinical staging of RCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]
timeFrame: After Nexavar administration, up to 1 year
measure: Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]
timeFrame: After Nexavar administration, up to 1 year
measure: The status of therapy with Nexavar [duration of treatment, daily dose]
timeFrame: After Nexavar administration, up to 1 year
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02373371: Actinic Keratoses Treatment With Metvix® in Combination With Light
Official title: Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2015-02-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison)


Eligibility criteria: Inclusion Criteria:

* Male or female above 18 years;
* Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

* Subject with clinical diagnosis of at least one severe AK on TAs
* Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
* Subject with pigmented AK on the TAs

Primary outcomes:
measure: Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Pain Assesment
timeFrame: at inclusion (after treatment)
measure: Lesions Disappearance Rate at 1 Months From Baseline.
timeFrame: 0(baseline),1 month
measure: Lesions Disappearance Rate at 6 Months From Baseline.
timeFrame: 0(baseline), 6 month
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
References:
Clinical trial NCT02006771: Cultural Meal and Postprandial Oxidative Stress
Official title: A Randomized Crossover Trial to Compare the Changes of Postprandial Oxidative Stress After Consumption of Meals From Different Cultures in Healthy Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: Meal
Postprandial oxidative stress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This one-year randomized crossover study is proposed to compare the changes of postprandial oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of POS differ with meals from different cultures. Four cultural meals are chosen, namely Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and Northern Chinese population.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy male or female of Chinese ethnicity with BMI less than 25 kg/m2
* Aged from 18 to 45 years for female to avoid menopausal effect, and 18 to 50 years for male (inclusive)
* Normal glucose tolerance as assessed by fasting HbA1c of \<6% at the screening
* Willing to give consent and follow the study procedures

Exclusion Criteria:

* Lifestyle factors that affect POS as shown by the literature including
* Current smoker
* Physically active as defined by three days or more of 30 minutes \[accumulated over the course of a day\] moderate to vigorous activity weekly in the past three months. Vigorous physical activity is described as causing heavy sweating or a large increase in breathing or heart rate, and moderate as causing light sweating or a slight to moderate increase in breathing or heart rate.
* Regular or current use of vitamin or antioxidant supplements
* Pregnant or lactating
* Concurrent participation in any clinical trial or dietary intervention program
* Adherence to a special diet, allergies or aversions to foods on the study meals
* Use of medications that could affect study outcomes
* With diabetes, hypertension, renal, liver or thyroid dysfunction, any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study

Primary outcomes:
measure: Change of plasma allantoin from 0 (pre-meal) to 6 hours post-meal
timeFrame: pre-meal (0 hour), 2, 4, 6 hours post-meal
Secondary outcomes:
measure: Change of urine F2-isoprostanes from 0 (pre-meal) to 6 hours post-meal
timeFrame: pre-meal (0 hour), 2, 4, 6 hours post-meal
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Ruth Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: