louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03665753: Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED
Official title: Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Renal Colic
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation study.
Primary purpose: TREATMENT

Brief summary: Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department

Detailed description: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).

Eligibility criteria: Inclusion Criteria:

* Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt

Exclusion Criteria:

* Age \>65
* Active Peptic Ulcer disease
* Acute Gastrointestinal Hemorrhage
* Known History of Renal or Hepatic insufficiency
* History of allergies to NSAIDs

Primary outcomes:
measure: Pain assessed with visual analogue scale (VAS)
timeFrame: 30 Minutes
Secondary outcomes:
measure: Pain assessed with visual analogue scale (VAS)
timeFrame: 15 Minutes
measure: Pain assessed with visual analogue scale (VAS)
timeFrame: 45 Minutes
measure: Pain assessed with visual analogue scale (VAS)
timeFrame: 60 Minutes
measure: Adverse Effects
timeFrame: 60 Minutes
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: IKCH
Study officials:
References:
citation: Eidinejad L, Bahreini M, Ahmadi A, Yazdchi M, Thiruganasambandamoorthy V, Mirfazaelian H. Comparison of intravenous ketorolac at three doses for treating renal colic in the emergency department: A noninferiority randomized controlled trial. Acad Emerg Med. 2021 Jul;28(7):768-775. doi: 10.1111/acem.14202. Epub 2021 Feb 17.
Clinical trial NCT02602353: Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)
Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group and Placebo-Controlled Pilot Study to Assess the Safety and Efficacy of a New Pain Patch Versus Placebo and No Treatment for the Treatment of Delayed Onset Muscle Soreness (DOMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delayed Onset Muscle Soreness
Lead sponsor: Lead Chemical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cardinal Health
First posted: 2015-11-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).


Eligibility criteria: Inclusion Criteria:

* Males or females, 18 to 40 years of age
* are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
* develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale

Exclusion Criteria:

* has engaged in upper extremity exercise for a minimum of 6 months prior to study participation
* has been working heavy manual or physical labor jobs within 3 months prior to study participation.
* has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
* has skin lesions such as psoriasis at the application site
* has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
* has an allergy-related skin condition

Primary outcomes:
measure: Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
timeFrame: 0-24 hours
Secondary outcomes:
measure: Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest
timeFrame: 0-24 hours
measure: Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement
timeFrame: 0-48 hours
measure: Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest
timeFrame: 0-48 hours
measure: Time to onset of first perceptible pain relief
timeFrame: First 4 hours after Dose 1
measure: Time to onset of meaningful pain relief
timeFrame: First 4 hours after Dose 1
measure: Subjects global impression of medication
timeFrame: Day 10
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Derek Muse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139853: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
Official title: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pyloric Stenosis
Keywords: pyloric stenosis
nasogastric tube
pyloromyotomy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2010-06-09
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. This study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.


Eligibility criteria: Inclusion Criteria:

1. Male or female infant ≤ 6 months of age
2. Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
3. Amendable to circumumbilical pyloromyotomy
4. Amendable to a minimum size 10 French nasogastric tube
5. Able to undergo general anesthesia
6. Parent or legal guardian able to give free and informed consent

Exclusion Criteria:

1. Contraindicated for circumumbilical pyloromyotomy
2. Contraindicated for a size 10 French nasogastric tube
3. Prematurity before 35 weeks' gestation
4. Bronchopulmonary dysplasia
5. Viral infection in the past 7 days
6. Cardiac malformation
7. Patent ductus arteriosis
8. Previous abdominal surgery
9. Concurrent surgical procedure scheduled
10. Parent or legal guardian unable to read, speak and understand English
11. Co-enrolled in a different interventional trial

Primary outcomes:
measure: Feasibility
timeFrame: 2 years
Secondary outcomes:
measure: post-operative length of stay
timeFrame: 1 year
measure: rates of post-operative emesis
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
Study officials:
affiliation: McMaster Children's Hopsital
name: Dr. Helene Flageole, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flageole HH, Pemberton J. Post-Operative Impact of Nasogastric Tubes on length of stay in infants with pyloric Stenosis (POINTS): A prospective randomized controlled pilot trial. J Pediatr Surg. 2015 Oct;50(10):1681-5. doi: 10.1016/j.jpedsurg.2015.02.023. Epub 2015 Feb 19.
Clinical trial NCT03043053: The Effects of Oxytocin in Obese Adults
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: weight loss
body mass index
oxytocin
magnetic resonance imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.


Eligibility criteria: Inclusion Criteria:

* 18-45 years old;
* BMI greater than or equal to 30 kg/m2

Exclusion Criteria:

* Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);
* history of medication changes within 4 weeks of enrollment;
* active substance use;
* history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;
* hematocrit \>2% below normal;
* fasting glucose \> 125 mg/dL or hemoglobin A1c ≥ 7% ;
* ALT or AST \>2.5 times upper limit of normal;
* Cr \>1.5 mg/dL; hyponatremia;
* pregnancy or breastfeeding;
* unwilling to use medically acceptable form of contraception (females only)
* follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
* current smoking or tobacco use

Primary outcomes:
measure: Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo
timeFrame: Baseline to 8 weeks
measure: Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo
timeFrame: Baseline to 8 weeks
measure: Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580853: The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Official title: The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Lapse Behavior
Keywords: smoking lapse behavior
smoking cessation
varenicline
bupropion
medication effect on smoking lapse behavior
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2007-12-27
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.


Eligibility criteria: Inclusion Criteria:

* ages 18-55
* able to read and write in English
* Smokers

Exclusion Criteria:

* any significant current medical or psychiatric conditions that would contraindicate smoking
* current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* women who are pregnant or nursing
* suicidal, homicidal, or evidence of current severe mental illness
* participants prescribed any psychotropic drug in the 30 days prior to study enrollment
* blood donation within the past 6 weeks
* individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
* specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
* known allergy to varenicline or taking H2blockers
* participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study

Primary outcomes:
measure: Latency to Initiate Ad-lib Smoking Session
timeFrame: 0 to 50 minutes
Secondary outcomes:
measure: Number of Cigarettes Smoked During the 60 Minute Ad-lib Period
timeFrame: 60 minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823653: Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound
Official title: A Study to Investigate the Safety and Efficacy of Treatment of Subcutaneous Adipose Tissue in the Thighs Using the Liposonix System (Model 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment of Adipose Tissue in the Thighs
Lead sponsor: Valeant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.

Detailed description: Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18-60 years of age
* Body Mass Index of ≤30 lb/in2
* Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
* Subjects must agree not to alter their regular diet or exercise routines during the course of the study
* Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
* Subject must understand the nature of the study and sign an IRB approved Informed Consent

Exclusion Criteria:

* Subjects is pregnant
* Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
* Subject has had prior aesthetic procedures in the area to be treated
* Subjects has pacemaker, defibrillator, or other implantable electrical device
* Subject has significant circumferential asymmetry between thighs

Primary outcomes:
measure: Clinical Improvement in Thigh Circumference
timeFrame: 12 weeks (minus baseline)
Secondary outcomes:
measure: Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator
timeFrame: 12 weeks
measure: Patient Satisfaction Using 1-5 Likert Scale
timeFrame: 12 weeks
measure: Safety Assessment
timeFrame: 1, 4, 8, 12 weeks
measure: Subcutaneous Adipose Thickness
timeFrame: 12 weeks
measure: Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paradise Valley
country: United States
facility: Van Dyke Laser and Skin
state: Arizona
city: Hayward
country: United States
facility: Solta Medical Aesthetic Center
state: California
city: Eugene
country: United States
facility: Jewell Plastic Surgery Center
state: Oregon
city: Toronto
country: Canada
facility: Solish M.D.
state: Ontario
Study officials:
References:
Clinical trial NCT06958653: Digital Computer Vision-based Balance Assessment System for Elderly
Official title: Development and Evaluation of a Digital Computer Vision-based Balance Assessment System for the Community Dwelling Elderly in China: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ELDERLY PEOPLE
Fall Prevention
Digital Health
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To help older adults assess their balance more reliably and independently, researchers developed a Digital Balance Testing System (DBTS). This system combines the Brief-Balance Evaluation Systems Test (Brief-BESTest) with OpenPose, a computer vision technology that tracks body movements using a standard camera.

This study aimed to evaluate the reliability of the DBTS and its impact on user experience in a controlled experimental setting. A total of 30 community-dwelling older adults (average age 66.2 ± 4.7 years) participated. Each person completed balance assessments using both the traditional Brief-BESTest and the DBTS.

To assess the reliability of the DBTS, the researchers analyzed the standard error of measurement and its correlation with scores from the Brief-BESTest. To evaluate user experience, participants rated their perceived physical fatigue and intrinsic motivation after each test session.


Eligibility criteria: Inclusion Criteria:

* aged 60 or older,
* living independently,
* able to walk with or without an assistive device (without external help),
* willing and able to provide informed consent.

Exclusion Criteria:

* conditions that impede walking (e.g., hip fractures, lower limb amputations, hemiparesis),
* medications causing dizziness or affecting balance (e.g., psychotropic drugs),
* self-reported cardiovascular, pulmonary, neurological, musculoskeletal, or mental disorders,
* severe fatigue or pain,
* severe uncorrected vision or hearing impairments that may affect their ability to interact with the digital system

Primary outcomes:
measure: Balance ability
timeFrame: Through intervention completion, an average of 10 mins
Secondary outcomes:
measure: Exercise confidence
timeFrame: Through intervention completion, an average of 10 mins
measure: Fatigue level
timeFrame: Through intervention completion, an average of 10 mins
measure: User experience
timeFrame: Through intervention completion, an average of 10 mins
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hongqiao Community
state: Shanghai
Study officials:
References:
Clinical trial NCT03433053: Developing and Examining Evidenced-Based HIV Testing Messages
Official title: Developing Evidenced-Based Health Messages to Increase HIV Testing Among African-American Young Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-02-14
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of this study are to:

1. Develop a HIV test message tailored for African American women. A generic non-tailored message will be developed as well for comparison. A third group will be included that will not be exposed to any message at all.
2. Test the effectiveness of both messages on reported future intentions to get tested for HIV and HIV test behavior at 3 month follow up.

Detailed description: African American women have the highest risk and prevalence of HIV infection among women of all racial/ethnic groups in the United States. Many of the current HIV infections among young adult African American women remain undiagnosed. The established benefits of routine HIV testing, the limitations of safer sex programs, and the gap of research related to increasing HIV testing as prevention necessitates the need for future research that specifically targets mechanisms to increase HIV testing. Higher rates of HIV testing can decrease rates of HIV transmission, as individuals who are knowledgeable of their status are less likely to transmit the virus. The current literature is sparse on factors related to HIV testing among young adults and has largely only examined demographic and sexual behavior correlates of HIV testing. Additionally, no studies have developed evidence-based health messages to promote HIV testing specifically among African American young women, despite their high risk of HIV infection and the importance of HIV testing. Thus, the proposed study will intend to identify factors related to HIV testing beyond the demographic and sexual risk level through formative research. These identified factors will be included as important elements in the development of HIV testing messages to motivate increased HIV testing. An enhanced message (culturally tailored) and a knowledge only message will be developed and tested.

Eligibility criteria: Inclusion Criteria:

* Self-identified Black or African American women

Exclusion Criteria:

* Women who have never had sex, are married, or are pregnant/attempting to become pregnant

Primary outcomes:
measure: HIV Test Intentions
timeFrame: Three month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Faye Belgrave, PhD
role: PRINCIPAL_INVESTIGATOR
References: