louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02375633: Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Back Pain
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-02
Enrollment: 166
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: A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.


Eligibility criteria: Inclusion Criteria:

* More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
* Class 1 or 2 back pain patients along Quebec Task Force Classification
* Patients with pain at least 40mm test results at visit2
* The voluntary or legal guardian 's written consent to participate in this clinical trial subjects

Exclusion Criteria:

* Severe gastrointestinal disease, heart disease, high blood pressure patients
* Patients with secondary causes are obvious
* Within 24 weeks patient who has back surgery before clinical trial participation
* Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
* Within 4 weeks patient who treated steroid drug by oral or injection
* Within 2 weeks patient who treated MAO inhibition drugs
* Patients with severe respiratory depression status

Primary outcomes:
measure: The change of 100 mm Pain VAS
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01780077: Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
Official title: A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cicatrix
Scar Prevention
Keywords: Scar
Scar prevention
Fibrosis
Lead sponsor: RXi Pharmaceuticals, Corp.
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.


Eligibility criteria: Inclusion Criteria:

* Males and females, 21-50 years of age
* General good health; if female not pregnant or lactating
* Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria:

* Pregnant or lactating
* Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study
* Type 1 or 2 diabetes mellitus
* A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator

Primary outcomes:
measure: To assess the safety and tolerability of multiple intradermal administrations of RXI-109
timeFrame: 12 weeks
Secondary outcomes:
measure: To assess the effect of multiple intradermal administrations of RXI-109 on scar formation
timeFrame: 12 weeks
Other outcomes:
measure: To assess the timeline and levels of biomarkers
timeFrame: 12 weeks
Locations:
Study officials:
References:
Clinical trial NCT05823077: Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis
Official title: Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effects of 4-week aromatherapy massage on pain, functionality, sleep quality and menopausal symptoms will be examined in individuals diagnosed with knee osteoarthritis during menopause.

Detailed description: The aim of this study is to investigate the effect of aromatherapy massage performed with bergamot oil for 4 weeks on pain, function, sleep and menopausal symptoms in menopausal women with knee osteoarthritis. Participants will be randomly divided into 3 groups as Bergamot, placebo and control. In addition to the conventional treatment, the Bergamot group will receive 2 sessions of Bergamot oil per week for 4 weeks, and the placebo group will be massaged with 2 sessions of sweet almond oil for 4 weeks. the control group will continue conventional treatment for 4 weeks. All assessments will be performed before starting treatment and at the end of 4 weeks of treatment. Participants' pain will be evaluated by VAS, Functions by WOMAC, Sleep quality by PSQI, menopausal symptoms by Menopause Symptoms Evaluation scale. At the end of the study, the satisfaction of the participants will be evaluated with VAS.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 40-65,
* having entered the menopause,
* being diagnosed with knee OA,
* being at the level of OA 2-3,
* having pain at rest in the knee VAS ≥ 4.

Exclusion Criteria:

* Any knee surgery
* known allergies to the oils to be used

Primary outcomes:
measure: Change from baseline in pain at 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in function at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in sleep quality at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in menopause symphtoms at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Patients satisfaction after the interventions
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT05622877: The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
Official title: The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Protein; Disease
Carotid Artery Plaque
Traditional Chinese Medicine
Keywords: Traditional Chinese Medicine
proteomic study
carotid atherosclerosis plaques
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials.

The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.


Eligibility criteria: Inclusion Criteria:

* Wet syndrome scale assessment is consistent with wet syndrome diagnosis;
* Carotid color ultrasound indicated carotid artery unstable plaque.
* Protein chip analysis determined that the patients were at high risk of stroke
* Signing informed Consent

Exclusion Criteria:

* Carotid artery stenosis rate ≥50%;
* A definite or suspected diagnosis of vasculitis;
* Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and
* kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2);
* Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris;
* Pregnant or lactating women;
* A prior known allergy to the test drug or the test drug ingredient.

Primary outcomes:
measure: Changes in carotid artery unstable plaque
timeFrame: 6 moths
Secondary outcomes:
measure: Changes in blood lipids
timeFrame: 6 moths
measure: Number of new cardiovascular events
timeFrame: 12 moths
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
Study officials:
References:
Clinical trial NCT04744077: Physical Activity and Social-media Support
Official title: Physical Activity and Social-media Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trust
Keywords: social media
physical activity
exercise
Lead sponsor: California State Polytechnic University, Pomona
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a 3-arm randomized intervention to provide exercise education through Instagram. The primary outcome is trust in the content presented.

Detailed description: Social media is an interpersonal-level technology that can provide physical activity support through social support and behavioral education. One popular social media platform is Instagram. However, there is limited data on whether participants trust the content delivered through this platform. There is also limited information on whether the social-media account holder plays a role in the acceptance of the content. The purpose of the proposed study is to determine participants perceptions of physical activity related information and social media account. The design for this study is a 3-arm randomized intervention through Instagram. Participants (n=60) will be randomized to one of three Instagram accounts (control, student, and scientist). Recruitment will be on a rolling basis for 2 months; once participants are deemed eligible, they will be enrolled for 4-weeks and will receive a weekly questionnaire to determine their perceptions. Participants will also be encouraged to participate in follow-up questionnaires at 2 and 3 months.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* less than 150 minutes of moderate-to-vigorous exercise per week
* active Instagram account

Exclusion Criteria:

* physical activity is inadvisable based on the PAR-Q+

Primary outcomes:
measure: Self-reported trust in Instagram content assessed with a likert scale
timeFrame: 4-weeks
Secondary outcomes:
measure: Physical activity measured by the IPAQ
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Pomona
country: United States
facility: California State Polytechnic University, Pomona
state: California
Study officials:
References:
Clinical trial NCT06435377: Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions
Official title: Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colonic Disease
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.

Brief summary: This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.


Eligibility criteria: Inclusion Criteria:

* All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
* Lesions of 20 mm and larger.
* All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
* Patients who were able to provide written informed consent

Exclusion Criteria:

* Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
* Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
* Pedunculated polyps
* Active/quiescent colitis
* Rectal lesions
* Residual or recurrent adenoma after endoscopic mucosal resection

Primary outcomes:
measure: Residual
timeFrame: 1 day
measure: Recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of procedure
timeFrame: 1 day
measure: Rate of delayed bleeding of the patient
timeFrame: 1 day
measure: Rate of post-polipectomy syndrome
timeFrame: 1 day
measure: perforation
timeFrame: 1 day
measure: Time
timeFrame: 1 day
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT00329277: Detection of Topographic Residual Acuity in Patients With Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: age-related macular degeneration
preferred retinal locus
macular perimetry
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2006-05-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Standard perimetry provides information on topographical retinal sensitivity to light stimuli, however the said locus is not necessarily the preferred locus for fixation. Standard perimetry could also be used as a way for macular scotoma mapping, indirectly showing the fixation locus. Topographic acuity at the preferred retinal locus can be determined if correlation between loci with high sensitivity, eccentric fixation loci and potential visual acuity measurements are correlated.

PURPOSE OF THE STUDY:

Determination of visual acuity at preferred retinal locus in Low Vision patients with ARMD using eye standard automated and computerized perimetry methods.


Eligibility criteria: Inclusion Criteria:

* AMD with documented pathology
* Low Vision both eyes
* BCVA 20/50-20/400 in best eye

Exclusion Criteria:

* Cognitive impairment
* Other retinal pathology
* Previous retinal surgery
* Significant media opacity

Primary outcomes:
measure: Location of eccentric retinal locus of highest fixation accuracy
Secondary outcomes:
measure: Location of eccentric locus with best retinal sensitivity
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dr S N Markowitz
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Samuel Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06783777: Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy
Official title: Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome (RDS)
Respiratory Ilness
Keywords: esophageal-pressure
tracheotomy tip pressure
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years old), regardless of gender
* Tracheostomized patients with spontaneous breathing;
* Weaning criteria: under the condition of mask oxygen inhalation at 5L/min, SPO2 \> 94%, PaO2/FiO2 \> 150 - 200.
* The patient has stable hemodynamics and pH ≥ 7.32;
* Agree to participate in this trial and sign the informed consent form.

Exclusion Criteria:

* Patients with contraindications for esophageal catheter insertion and unable to monitor esophageal pressure;
* Patients with bleeding risks: severe coagulation disorders, esophageal varices；
* Local injuries: basilar skull fracture, maxillofacial fracture;
* Pregnant women;
* Patients considered not suitable by the researcher.

Primary outcomes:
measure: Correlation between esophageal pressure and tracheotomy tip pressure
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital afraid of Fudan university
Study officials:
References:
Clinical trial NCT04278677: Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Official title: Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a provider-crossover study design.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo primary ARCR
* Patient willing and able to complete postoperative surveys

Exclusion Criteria:

* Daily melatonin use for \> 1 week during the last 3 months
* Irreparable tears
* Revision rotator cuff repairs
* Severe glenohumeral arthritis
* Concurrent adhesive capsulitis
* Age less than 18
* Pregnancy
* History of substance abuse (drug or alcohol)
* Workman's comp patient or patient has current litigation pending
* Allergy to melatonin
* History of delirium/psychiatric/depression/ on antidepressants
* History of insomnia/ on sleep aid medication
* Use of prescription sedatives
* use of Zelboraf (vemurafenib)
* Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
* Sleep apnea

Primary outcomes:
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 6 weeks post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Orthopaedics at Egg Harbor Township
state: New Jersey
Study officials:
References:
Clinical trial NCT04872777: Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH
Official title: Mobile Health Delivered Lifestyle Intervention Program in Patients With Nonalcoholic Steatohepatitis: A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Noom Inc.
First posted: 2021-05-05
Enrollment: 40
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: There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle intervention can be removed with a mobile health (mHealth) platform.

This study will be a proof of concept study to evaluate weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with NASH.


Eligibility criteria: Inclusion Criteria:

* Adults age \>18 years
* NASH defined as:
* Liver biopsy with evidence of steatohepatitis (NAS \>=4) or;
* Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following:
* Fibroscan kPa \>8.2 or;
* FAST \> 0.35 or;
* FIB-4 \>= 1.45 or;
* Possession of a smartphone

Exclusion Criteria:

* Active or recent (\<90 days) participation in lifestyle intervention program, including weight-loss program
* Active weight-loss supplement use
* Cirrhosis
* Inability to provide informed consent
* Institutionalized/prisoner
* Other chronic liver disease (e.g., viral hepatitis)
* Recent Noom use (\<180 days)
* Secondary cause of hepatic steatosis, including significant alcohol consumption (men \>30g/d, women \>20g/d)
* Severe medical comorbidities/psychiatric illness at the discretion of the study PI

Primary outcomes:
measure: Weight
timeFrame: 16 weeks
Secondary outcomes:
measure: liver enzymes
timeFrame: 16 weeks
measure: Noom healthy weight engagement
timeFrame: 16 weeks
measure: Glucose
timeFrame: 16 weeks
measure: hemoglobin A1c
timeFrame: 16 weeks
measure: Cholesterol level
timeFrame: 16 weeks
measure: NAFLD Fibrosis Score
timeFrame: 16 weeks
measure: IgA level
timeFrame: 16 weeks
measure: Ferritin
timeFrame: 16 weeks
measure: histology
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jonathan G Stine, MD
role: PRINCIPAL_INVESTIGATOR
References: