louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00655811: Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
Official title: Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to study how people respond differently to capsaicin in different racial groups and the effect it has on your pain levels. Capsaicin is a natural product made from hot chili peppers that is useful for treating the itch symptoms of skin disease.

Detailed description: To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.

Eligibility criteria: Inclusion Criteria:

* Adult men and women who are between 18 and 50 years of age.
* Subjects must be in general good health with no skin disease, disease state or physical condition which would impair evaluation of pain perception or which would increase their health risk by study participation as determined by the investigators.
* Women of childbearing potential will be required to have a negative pregnancy test in order to enroll in the study.

Exclusion Criteria:

* Adults over age 50.
* Children less than 18 years of age.
* Unable to complete the required measures.
* Diagnosis of diseases that would affect the measurement of pain perception.
* Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 30 days prior to study participation.
* Use of oral analgesic or other medications known to interfere with pain perception in the week prior to the study.
* Use of emollient on the forearms on the day of the study visit.
* Use of medicated topical preparations on the forearms for the week prior to the study.
* Known history of neuropathy causing diseases such as uremia.
* Known history of uncontrolled thyroid disease.
* Known history of diabetes mellitus.
* Allergy to capsaicin.
* Pregnant women.

Primary outcomes:
measure: Ethnic Differences in Burning Pain Induced by Topical Capsaicin
timeFrame: 1 day
Secondary outcomes:
measure: Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds
timeFrame: 1 day
measure: The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.
timeFrame: 1 day
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gil Yosipovitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01077011: Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye

Exclusion Criteria:

* Must not have worn contact lenses within 12 hours preceding enrollment
* Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Primary outcomes:
measure: Three-minute visual blur profile
timeFrame: Through 3 minutes (post-instillation)
measure: Overall Acceptability
timeFrame: Immediately upon instillation
Secondary outcomes:
measure: Drop Comfort Upon Instillation
timeFrame: Immediately upon installation
Other outcomes:
Locations:
Study officials:
References:
citation: http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel
Clinical trial NCT04199611: Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
Official title: Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Body Image
Keywords: Body Image Satisfaction
Liposuction
Psychological Therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Global 365MC Hospital
First posted: 2019-12-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat cognitive distortion for body image. Then, validate its efficacy to make an improvement in both physical and mental health.


Eligibility criteria: Inclusion Criteria:

* BMI 25\~30
* The score over 68 in SIMS (The situational motivation scale)

Exclusion Criteria:

* Diagnosed in any chronic disease
* Trouble using smartphone
* Pregnant or planning to be pregnant
* Unable to be in the fMRI
* Limited to be involved in physical activities over 30 minutes
* already had an experience in liposuction

Primary outcomes:
measure: BSQ-8C
timeFrame: 4 weeks, 8-item, scale 1 through 6
Secondary outcomes:
measure: fMRI
timeFrame: 24 hours
measure: Computerized cognitive behavioral task
timeFrame: 24 hours
measure: KoQoL
timeFrame: 24 hours, 13-item, scale 1 through 4
measure: DEBQ
timeFrame: 24 hours, 33-item, scale 1 through 5
measure: K-BDI
timeFrame: 24 hours, 21-item, scale 1 through 4
measure: RSES
timeFrame: 24 hours, 10-item, scale 1 through 4
measure: TAI
timeFrame: 24 hours, 20-item, scale 1 through 4
measure: PANAS
timeFrame: 24 hours, 20-item, scale 1 through 5
measure: SCL-90-R
timeFrame: 24 hours, 90-item, scale 1 through 5
measure: EAT-26
timeFrame: 24 hours, 26-item, scale 1 through 6
measure: K-AAQ-II
timeFrame: 24 hours, 10-item, scale 1 through 7
measure: Cognitive bias on the body image
timeFrame: 24 hours, one-item, scale 1 through 4
measure: BMI in kg/m^2
timeFrame: 24 hours
measure: Body fat percent
timeFrame: 24 hours
measure: Leg circumference
timeFrame: 24 hours
measure: Waist circumference
timeFrame: 24 hours
measure: Glucose
timeFrame: 24 hours
measure: ALT
timeFrame: 24 hours
measure: AST
timeFrame: 24 hours
measure: GGT
timeFrame: 24 hours
measure: Total Cholesterol
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Meelim Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00932711: Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
Official title: Limited Intervention in Low Risk(Tier 3) COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2009-07-03
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
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 educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.

Detailed description: There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients.

Eligibility criteria: Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC \<70%.

Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year

-

Primary outcomes:
measure: Combined frequency of admissions and ED visits for COPD over 1 year.
timeFrame: One year
Secondary outcomes:
measure: Patient knowledge of COPD will be compared.
timeFrame: 1 year
measure: Use of respiratory medications will be compared
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Kathryn Rice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725811: Immediate Effects of Myofascial Release on the Quadriceps or Hamstrings on Active Cervical Range of Motion
Official title: Immediate Effects of Myofascial Release on the Quadriceps or Hamstrings on Active Cervical Flexion and Extension Range of Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to verify the immediate effects of quadriceps or hamstring myofascial release on the active cervical flexion and extension range of motion.

Detailed description: After completing the questionnaire, 60 healthy college students will be randomly divided into three groups named Intervention Group 1 (IG 1) (n=20), Intervention Group 2 (IG 2) (n=20) and Control Group (CG) (n=20). In the first assessment (M0), the cervical flexion and extension range of motion will be measured with a goniometer. The myofascial release technique (foam roller) will be applied on the hamstrings (IG 1) or quadriceps (IG 2) of the dominant lower limb for 4 minutes (3 series of 1 minute with 30s rest). Participants in the control group will remain at rest sitting in a chair for 4 minutes.

Immediately after the intervention/control, both groups will be assessed, again (M1).

Eligibility criteria: Inclusion Criteria:

* Healthy university students of both genders with normal mobility of the joints.

Exclusion Criteria:

* Deformities in the lower quadrant region of the body;
* Complaints in this region in the last 6 months;
* Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies
* Pregnant women
* Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.

Primary outcomes:
measure: Change of active cervical range of motion in flexion and extension.
timeFrame: Change from Baseline (M0) to Immediately after intervention or control (M1)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Ricardo Cardoso
city: Porto
country: Portugal
facility: Ricardo Cardoso
Study officials:
References:
Clinical trial NCT00683111: Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Official title: Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Acute Myocardial Infarction
Keywords: acute coronary syndrome
acute myocardial infarction
aspirin
clopidogrel
heparin
thrombolytic
famotidine
esomeprazole
Lead sponsor: Ruttonjee Hospital
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.


Eligibility criteria: Inclusion Criteria:

* patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)

Exclusion Criteria:

* known active peptic ulcer disease or gastrointestinal within 8 wk
* known iron deficiency anemia with Hb \< 10 gm/dl
* mechanical ventilation
* active cancer, liver cirrhosis, end-stage renal failure
* life expectancy \< 1 yr
* known allergic to aspirin, clopidogrel, enoxaparin famotidine or esomeprazole
* pregnancy, lactation, child-bearing potential in the absence of contraception,
* co-prescription of NSAID, corticosteroid, or warfarin
* non-oral feeding or impaired GI absorption e.g. vomiting
* already on proton pump inhibitor for \> 1 day or another clinical trial drug for ulcer disease

Primary outcomes:
measure: ulcer complication (bleeding/perforation/obstruction)
timeFrame: up to 12 months
Secondary outcomes:
measure: Termination of anti-ischemic drug due to ulcer complications; TIMI severity of GI bleeding; Major adverse cardiac event (composite of death from CV causes, recurrent nonfatal MI, or stroke);
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Ruttonjee Hospital
Study officials:
affiliation: Ruttonjee Hospital
name: Fook Hong Ng, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng FH, Tunggal P, Chu WM, Lam KF, Li A, Chan K, Lau YK, Kng C, Keung KK, Kwan A, Wong BC. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012 Mar;107(3):389-96. doi: 10.1038/ajg.2011.385. Epub 2011 Nov 22.
Clinical trial NCT06290011: A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
Official title: A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR in the Treatment of Chronic Pain: a Multicenter, Randomized Controlled, Single Blind Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic pain lasts for more than 3 months;

Brief summary: A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain

Detailed description: Multi-center, prospective, single-blind, randomized and parallel controlled trials are used to evaluate the role and impact of "digital chronic pain treatment system equipment" based on MR mixed reality technology in the clinical basic treatment of patients clinically diagnosed with chronic pain.

Eligibility criteria: Inclusion Criteria:

1. 18-85 years old male and female;
2. Patients clinically diagnosed with chronic pain;
3. Chronic pain lasts for more than 3 months;
4. The average intensity of pain in the past month is 40mm and above (VAS);
5. Willing to abide by the relevant regulations of the experiment;

Exclusion Criteria:

1. Serious cognitive impairment;
2. Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects;
3. Symptoms of nausea or dizziness;
4. Sensitive to luminous screens;
5. No stereo vision or severe hearing impairment;
6. Eye, face or neck injuries, which hinder the comfortable use of glasses;
7. The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above;
8. Have used VR or MR and other related devices to treat pain;
9. Other clinical studies have been completed now or recently (the past 2 months);
10. Currently pregnant or planning to get pregnant during the study;
11. At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.

Primary outcomes:
measure: Visual Analogue Scale/Score（VAS）
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ke Ma
state: Yangpu
Study officials:
affiliation: studay chair
name: Ke NA Ma, phd
role: STUDY_CHAIR
References:
Clinical trial NCT00152711: Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
Official title: Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis: A Prospective Cross Over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea Syndrome
Nonalcoholic Steatohepatitis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the impact of nasal continuous positive airway pressure (nCPAP) treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic steatohepatitis. Using a cross over design, the evolution of liver enzymes will be evaluated in 40 patients during a consecutive period of 6 weeks, with and without nCPAP treatment.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years old
* Nonalcoholic steatohepatitis proven by liver biopsy
* Sleep apnea syndrome proven by polysomnography with an apnea-hypopnea index \> 10 events/hour
* Informed consent

Exclusion Criteria:

* Psychiatric disorder
* Other cause of liver disease
* Professional driver

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
Study officials:
affiliation: UH Angers
name: Frédéric Gagnadoux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00209911: Study of the Effect of Cardioversion on Cardiac Volume in Patients With Persistent Atrial Fibrillation
Official title: Atrial and Ventricular Volume and Function In Atrial Fibrillation - A Magnetic Resonance Imaging Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Keywords: atrial volume
ventricular volume
atrial function
ventricular function
magnetic resonance imaging
cardioversion
natriuretic peptides
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: The Foundation of 17.12.1981
name: AP Moeller Foundation
name: Danish Hospital Foundation for Medical Research, Region of Copenhagen
name: Danish Heart Foundation
name: Copenhagen Hospital Corporation
First posted: 2005-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: The main objectives in this study were to examine the cardiac structural and functional changes in patients with persistent and permanent AF, with the aim of improving our understanding of the underlying pathophysiological mechanisms. In addition we aimed to identify variables predictive of recurrent AF.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* severe pulmonary or renal disease
* contraindications to magnetic resonance imaging
* valvular disease
* previous cardiac surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Cardiology, Copenhagen University Hospital Hvidovre
Study officials:
name: Susette Krohn Therkelsen, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Therkelsen SK, Groenning BA, Svendsen JH, Jensen GB. Atrial and ventricular volume and function in persistent and permanent atrial fibrillation, a magnetic resonance imaging study. J Cardiovasc Magn Reson. 2005;7(2):465-73. doi: 10.1081/jcmr-200053618.
Clinical trial NCT04757311: Metastatic Colorectal Cancer. Real-World Data Analysis.
Official title: The Treatment Choices, Duration and Outcomes in Patients With Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed within 3-years period before March 2019 will be included.

Brief summary: The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

Detailed description: In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.

Eligibility criteria: Inclusion Criteria:

1. Patients who have been histologically diagnosed with mCRC
2. Patients over the age of 18
3. Patients receiving at least a cycle systemic treatment for metastatic disease
4. RAS wild type patients
5. Patients who has demographic, histopathological and clinical information

Exclusion Criteria:

1. Patients diagnosed as mCRC but only referred to BSC
2. Patients with RAS mutation
3. Patients who were included in any clinical trial except standard treatments during their treatment

Primary outcomes:
measure: Percentage of use anti-EGFR agents
timeFrame: throughout of treatment, 3 years
measure: Progression Free Survival (PFS)
timeFrame: 3 years treatment
Secondary outcomes:
measure: Advers events
timeFrame: throughout of treatment, 3 years
Other outcomes:
measure: Percentage of use biologics in right side tumors.
timeFrame: throughout of treatment, 3 years
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Hospital
Study officials:
References: