louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04069104: Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
Official title: Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnoses Disease
Keywords: Melanoma identification
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults living in U.S. who are members of the online panel.

Brief summary: The purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.


Eligibility criteria: Inclusion Criteria:

* Resident of U.S.
* At least 18 years old
* Capable of reading English
* Member of panel assembled by survey provider

Exclusion Criteria:

* Individuals under 18 years old

Primary outcomes:
measure: Mole identification accuracy
timeFrame: Day 2
Secondary outcomes:
measure: Skin Self Exam Intentions
timeFrame: Day 2
measure: Intentions to see a Dermatologist
timeFrame: Day 2
measure: Skin Self Exam Attitudes
timeFrame: Day 2
measure: Skin Self Exam Beliefs
timeFrame: Day 2
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Study Co-Principal Investigator
name: Nicholas Carcioppolo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Co-Principal Investigator
name: Soyoon Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06909604: Al18F-HER2-BCH PET in Breast Patients Treated With Neoadjuvant Therapy
Official title: Al18F-HER2-BCH PET/CT to Predict Response in Breast Patients Treated With Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
PET/CT
Neoadjuvant therapy
HER2 expression
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Qingdao University
name: North Sichuan Medical College
First posted: 2025-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value in breast patients treated with neoadjuvant therapy


Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years old; ECOG 0 or 1;
2. Patients with newly diagnosis HER2 positive or suspicious positive tumors;
3. Receives neoadjuvant therapy
4. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
5. Life expectancy \> 3 months -

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refused to join the clinical research;
5. Suffering from claustrophobia or other mental disorders;
6. Any other situation that researchers considered it unsuitable to participate in the trial.

Primary outcomes:
measure: Changes in SUVmax before and after treatment
timeFrame: Before treatment, 9 weeks after treatment, before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
Study officials:
References:
Clinical trial NCT02709304: Efficacy of Lidocaine Gel in Reducing Foley Catheter Discomfort in Surgical Patients
Official title: Exploring the Potential Efficacy of Lidocaine Gel in Reducing Discomfort in Patients Undergoing Surgical Procedures Requiring Foley Catheter Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Catheter Discomfort in Surgical Patients
Keywords: urinary catheter discomfort
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease pain and discomfort associate with Foley catheters upon awakening from general anesthesia in the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial colony counts from urine obtained from the surgical patients after insertion of the Foley catheter prior to prophylactic antimicrobial administration.


Eligibility criteria: Inclusion Criteria:

* Males requiring catheterization for surgical procedures scheduled for less than 4 hours.

Exclusion Criteria:

* Females, patients with preexisting urological conditions, and infections

Primary outcomes:
measure: Decrease postoperative urinary catheter related discomfort
timeFrame: Within 1 hour of emergence from general anesthetic
Secondary outcomes:
measure: decreased incidence of bacteriuria
timeFrame: immediate post catheter insertion and at 2 hour time point
Other outcomes:
Locations:
Study officials:
affiliation: Creighton University School of Medicine / CHI Health
name: Mark D Reisbig, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05526404: Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
Official title: Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is being done to assess the safety and efficacy of using mobile application-based Bristol stool scale to titrate lactulose in prevention episodes of hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written, informed consent.
* Currently taking lactulose daily for prevention of hepatic encephalopathy.

Exclusion Criteria:

* Recent change in dosing of opioid medication.
* Previous Colorectal Surgery.
* Active diarrheal illness.
* Lack of smartphone or other smart device at home.

Primary outcomes:
measure: Achievement of daily stool goal
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Douglas Simonetto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05111704: Short-term Effects of Postural Taping on Pain and Neck Posture
Official title: Short-term Effects of Postural Taping on Pain and Neck Posture: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain, Posterior
Keywords: posture
Balance Body Tape
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: Halmstad University
First posted: 2021-11-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 26 subjects experiencing pain in neck, back or shoulders were randomized into either an intervention group (n=12) or control group (n=14).
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of a short treatment period with Balance Body Tape on the intensity of perceived neck, shoulder and back pain and neck posture.

Detailed description: The aim of this study was to investigate the effects of a short treatment period with Balance Body Tape on the intensity of perceived neck, shoulder and back pain and neck posture.

Method 26 subjects who reported being university students or having a sedentary work and experiencing pain in neck, back or shoulders were randomized into intervention- (n=12) and control group (n=14).

The intervention group received a three-week treatment with BBT, the control group received no treatment. A questionnaire regarding pain, including a Numeric Rating Scale (NRS) measuring pain intensity, and a Photographic posture analysis measurement (PPAM) of habitual sitting posture were accomplished before and after the intervention for both groups. Wilcoxon´s signed rank test and Mann-Whitney U test was used to assess intra- and between group differences respectively. The relationship between pain intensity and CV-angle was assessed using Spearman's rank-order correlation.

Eligibility criteria: Inclusion Criteria:

* Aged 18-39
* University student or having a sedentary work
* Experienced of neck, shoulder and/or back pain, during prolonged sitting
* Minimum of 2-point score at the Numeric Rating Scale.

Exclusion Criteria:

* Severe back or neck injuries within the last 3 months
* Ongoing treatment plan for any back or neck problems
* Severe contact allergy or eczema
* Previously tried Body Balance Tape.

Primary outcomes:
measure: Pain intensity
timeFrame: Three week
measure: Craniovertebral angle
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Sofia Ryman Augustsson
Study officials:
References:
citation: Augustsson SR, Reinodt S, Sunesson E, Haglund E. Short-term effects of postural taping on pain and forward head posture: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Feb 19;23(1):162. doi: 10.1186/s12891-022-05083-5.
Clinical trial NCT02137304: A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
Official title: A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Disease
Keywords: cough help
in-exsufflation
neuromuscular disease
cough assistance optimization
efficient cough flow
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 40
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 investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Detailed description: he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Eligibility criteria: Inclusion Criteria:

* man or female age18 years
* neuromuscular disease
* coughassist adaptation treatment
* peak cough flow\<270liter/minute

Exclusion Criteria:

* acute organ failure
* insufflation contrindication
* pregnant women/no affiliation to a social security scheme
* plan of legal protection

Primary outcomes:
measure: optimal negative pressure treshold value
timeFrame: 20 minutes
Secondary outcomes:
measure: optimal pressure treshold based on the best peak flow.
timeFrame: 10 minutes
measure: volume-flow curve aspect
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital R. POINCARE
Study officials:
affiliation: AP-HP Hopital R. Poincaré Garches
name: Frederic LOFASO, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lacombe M, Bore A, Amo Castrillo LD, Boussaid G, Falaize L, Vlachos E, Orlikowski D, Prigent H, Lofaso F. Peak Cough Flow Fails to Detect Upper Airway Collapse During Negative Pressure Titration for Cough-Assist. Arch Phys Med Rehabil. 2019 Dec;100(12):2346-2353. doi: 10.1016/j.apmr.2019.06.012. Epub 2019 Jul 24.
Clinical trial NCT00754104: Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors
Official title: A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2008-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors


Eligibility criteria: Inclusion Criteria:

* Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
* Subject must have an ECOG Score of 0-2.
* Adequate organ function.

Exclusion Criteria:

* Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
* Subject has untreated brain or meningeal metastases.
* History of greater than 10% weight loss.
* Has clinically relevant hemoptysis.
* Subject has proteinuria CTC grade \> 1.
* Must not have had radiation therapy or major surgery within 21 days of study day 1.
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) \> 100 mmHg or systolic blood pressure (SBP) \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
* The subject has a documented left ventricular ejection fraction (LVEF) \< 50%.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Day 7, 15, 21, 35 and Day 1 of every 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01081704: A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects
Official title: A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Chinese male
Stelara
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of the pharmacokinetics of ustekinumab in Chinese male subjects.

Detailed description: This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of ustekinumab (Stelara). The study population will consist of 24 healthy male participants in China. Participants will receive a single dose of either 45mg or 90 mg ustekinumab. Participants will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.

Eligibility criteria: Inclusion Criteria:

* Have no clinically relevant abnormalities
* Non smoker

Exclusion Criteria:

* Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any underlying physical or psychological medical condition
* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Primary outcomes:
measure: Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.
timeFrame: Week 16
Secondary outcomes:
measure: Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events
timeFrame: Week 16
measure: Immune response (immunogenicity) of ustekinumab
timeFrame: Week 16
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Zhu Y, Wang Q, Frederick B, Bouman-Thio E, Marini JC, Keen M, Petty KJ, Davis HM, Zhou H. Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies. Clin Drug Investig. 2013 Apr;33(4):291-301. doi: 10.1007/s40261-013-0072-2.
Clinical trial NCT00758004: Bioequivalence Study Of Pediatric Appropriate Formulation
Official title: An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: Cardiovascular Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Detailed description: Determination of Bioequivalence

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female volunteers
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screening

Primary outcomes:
measure: Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
timeFrame: 5 months
Secondary outcomes:
measure: Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.
timeFrame: 5 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04372004: Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Official title: Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.

Detailed description: The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection

Eligibility criteria: Inclusion Criteria:

* • Male or female over 18 years of age at the time of enrollment

  * Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present

    * Dry cough
    * Sore throat
    * Shortness of breath
    * Chills
    * Muscle pain
    * Headache
    * New loss of taste or smell
    * Chills with repeated shaking

Exclusion Criteria:

* • Unwilling to provide informed consent

  * Unwilling to undergo bi-weekly serological test during the 1-month enrollment

Primary outcomes:
measure: detection of viral infection using serology and viral-RNA detection kits
timeFrame: 1 day
Secondary outcomes:
measure: Temporal trend of antibodies in blood
timeFrame: 1 month
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
Study officials:
References:
Clinical trial NCT06587204: Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
Official title: Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Diseases
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .


Eligibility criteria: Inclusion Criteria:

* History of pre-diabetes/diabetes and/or pre-hypertension/hypertension
* History of Cardiometabolic risk factors including the following: hypertension, Coronary Artery Disease (CAD), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, Peripheral Artery Disease (PAD), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol.
* Identify as Black or non-White Hispanic
* Own a smart phone

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Percentage of participants adhering to the intervention
timeFrame: 3 months
measure: Percentage of participants retained in the intervention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Azizi Seixas, PhD
role: PRINCIPAL_INVESTIGATOR
References: