louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03051295: Dentists' Understanding of Diagnostic Test Results and Treatment Efficacy.
Official title: The Influence of Different Formats for Presenting Diagnostic Test Results and Treatment Efficacy on Dentists' Understanding and on Their Reported Clinical Management.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Education
Keywords: Communication Barriers
Persuasive Communication
Risk
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is little evidence on how best to present diagnostic and treatment effect information to dentists and whether this makes any difference to their understanding of the information given and clinical management. The objective of this study is to assess the influence of different formats for presenting diagnostic test results and treatment efficacy on dentists' understanding and on their reported clinical management. The hypothesis is that presenting diagnostic test and treatment effectiveness results using natural frequencies influences the threshold for treatment and improves interpretation of tests results compared to conditional probabilities and percentage differences. A group of dentists recruited from postgraduate courses were randomized to two of four arms, being two arms of a hypothetical realistic diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1) diagnostic test results presented in conditional probabilities; a2) diagnostic test results presented in natural frequencies; b1) treatment efficacy presented in percentages; b2) treatment efficacy presented in natural frequencies. The main outcome measures were the correct answer as to whether disease was actually present (post-test probability) and the correct answer as the number of patients that would benefit from the treatment (efficacy). Secondary outcome measures included the decision whether to treat or not treat the hypothetical patient.


Eligibility criteria: Inclusion Criteria:

* Graduated dentist undergoing a postgraduate course in a public university in Rio de Janeiro.

Exclusion Criteria:

* None.

Primary outcomes:
measure: The probability that a patient will have a dental cavity as assessed by a dentist.
timeFrame: Up to 20 minutes
measure: The number of patients that will benefit from systemic antibiotics adjunct to periodontal treatment as assessed by a dentist.
timeFrame: Up to 20 minutes
Secondary outcomes:
measure: The number of dentists that would recommend the use of systemic antibiotics adjunct to periodontal treatment in the clinical management of a patient with periodontal disease.
timeFrame: Up to 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07011095: DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial
Official title: A Pilot Trial to Assess the Feasibility of a Multicentre, Phase IV, Prospective, Randomized, Open-label, Two-arm Study With Blinded-endpoint Evaluation to Investigate Vitamin K Antagonist (VKA) Therapy Compared With Direct Oral Anticoagulant (DOAC) Therapy in Male and Female Participants With Atrial Fibrillation and Recent Ischemic Stroke While on a DOAC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Atrial Fibrillation (AF)
Stroke (in Patients With Atrial Fibrillation)
Keywords: stroke
atrial fibrillation
A-Fib
SWITCH-AF
DOAC
Warfarin
Anticoagulant
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: People with atrial fibrillation who have a stroke while receiving a DOAC are at increased risk of experiencing another stroke. Physicians do not know the best medication to prevent another stroke in this group of people. Options include continuing the same DOAC, switching to another DOAC or switching to warfarin.

The investigators of the SWITCH-AF trial are trying to find out whether switching to warfarin or continuing a DOAC is better for preventing stroke.

The purpose of this study, called a pilot study, is to test the study plan and to find out whether enough participants will join a larger study that answers the question. A pilot study involves a small number of participants and it is not expected to tell us which treatment is better.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent provided.
2. Age \>18 years.
3. Documented history of AF or atrial flutter.
4. Ischemic stroke while on a DOAC within 14 days prior to enrollment identified on imaging.
5. In the opinion of the investigator, it is safe to initiate oral anticoagulation with either a VKA or a DOAC within 24 hours of randomization-

Exclusion Criteria:

1. There is strong evidence for the qualifying stroke event to be associated with permanent discontinuation of DOAC therapy (for any reason)
2. Patient is unable or unwilling to take oral anticoagulation
3. History of intracranial bleeding.
4. Patient is on chronic hemodialysis or likely to need renal replacement therapy during the course of the trial.

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: From site activation until the end of recruitment (approximately 24 months)
Secondary outcomes:
measure: Feasibility - Adherence to Assigned Medication
timeFrame: Enrollment to final visit (average 12 months)
measure: Feasibility - Retention
timeFrame: At 6 months from randomization
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00713895: Treating Chinese Smokers With Interactive Expert System
Official title: Treating Chinese Smokers With Interactive Expert System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
randomized trial
Asian
Chinese American
stages of change
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-07-14
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.

Detailed description: The research study examines the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population. The primary specific aim of the proposed research is to test the following hypotheses: 1) Proactive recruitment approach will be more effective in recruiting smokers who are in precontemplation (no intent to quit smoking in the next 6 months) than a reactive approach. 2) Participants in the experimental condition receiving the interactive stage-matched expert system intervention plus a manual will be more likely to be abstinent at 12 and 18 than those in the control condition receiving a non-interactive standard manual. 3) Participants receiving the interactive expert system intervention will be more likely to report at least one quit attempt than those in the control condition at months 6, 12, and 18. 4) Participants receiving the interactive expert system intervention will be more likely to have a significant decrease in number of cigarettes smoked than those in the control condition at months 3, 6, 12, and 18. After the intervention adaptation and the pilot testing phase of study procedures, the study will achieve the above aims using a randomized trial targeting 400 Chinese American Smokers with follow-up assessments at 3, 6, 12, and 18 months after baseline.

Eligibility criteria: Inclusion Criteria:

* residents of the San Francisco Bay Area
* age 18 or older
* self-identified as Chinese in ethnicity
* able to read English or Chinese
* have smoked at least 100 cigarettes in their lifetime
* currently smoke at least 5 cigarettes in the past 7 days

Exclusion Criteria:

* currently engaging in other smoking cessation efforts.

Primary outcomes:
measure: abstinence
timeFrame: 18 months
Secondary outcomes:
measure: quit attempt
timeFrame: 18 months
measure: reduction
timeFrame: 18 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Langley Porter
state: California
Study officials:
affiliation: University of California, San Francisco
name: Janice Tsoh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02535195: Effect of Ginger Supplement on Non-alcoholic Fatty Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study was that ginger supplement consumption can be introduced as a new therapeutic strategy for non-alcoholic fatty liver disease through the improved body antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized double-blind study was designed to evaluate this hypothesis in order to examine the effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* presence of steatosis on ultrasound examination
* high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)

Exclusion Criteria:

* various types of hepatitis
* diabetes mellitus
* cancer inherited disorders affecting liver condition (storage disorders of iron, copper, and others)
* non-treated hypothyroidism
* using alcohol
* consumption of phenytoin amoxyfan and lithium
* using minerals multivitamin supplements such as vitamin E, vitamin D, supplements made from Silybum marianum extract like livergol
* weight loss surgery in the last year or strict diets to weight loss in the past three months pregnancy
* lactation
* autoimmune diseases

Primary outcomes:
measure: Serum levels of the ALT liver enzyme
timeFrame: 12 weeks
measure: Serum levels of the AST liver enzyme
timeFrame: 12 weeks
Secondary outcomes:
measure: controlled attenuation parameter(CAP) score
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05155995: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 71
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUCt
timeFrame: 0~48hr
measure: Cmax
timeFrame: 0~48hr
Secondary outcomes:
measure: AUCinf
timeFrame: 0~48hr
measure: Tmax
timeFrame: 0~48hr
measure: t1/2
timeFrame: 0~48hr
measure: CL/F
timeFrame: 0~48hr
measure: Vd/F
timeFrame: 0~48hr
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingeul Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04027595: Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists
Official title: Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy: Efficacy and Outcomes Performed by Optometrists
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Posterior Capsule Opacification Obscuring Vision
Lead sponsor: Northeastern State University
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Existing patients at primary eye care optometric facilities.

Brief summary: The purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (Nd: YAG) laser capsulotomy procedures.

Detailed description: Participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. Participants will undergo the Nd: YAG laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. Follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. The complication rate following the laser capsulotomy procedure is typically minimal.

Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent;
2. At least 18 years of age, male or female;
3. Prior cataract surgery;
4. Diagnosed with posterior capsule opacification obstructing vision;
5. Best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an ETDRS visual acuity chart or significant effect on activities of daily living

Exclusion Criteria:

1. History of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings)
2. Previous myopic refractive error greater than 6.00 diopters
3. Complications following previous ocular procedures (i.e. intraocular lens decentration)
4. Ocular surgery other than uncomplicated cataract or uncomplicated refractive surgery

Primary outcomes:
measure: Central Visual Acuity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tahlequah
country: United States
facility: Northeastern State University
state: Oklahoma
Study officials:
affiliation: Northeastern State University
name: Nathan Lighthizer, OD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03267095: Use Music Therapy In Autism Spectrum Disorder
Official title: The Use Of Music Therapy In Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Music therapy is an established form of creative art therapy. By using music as a specific medium of communication, expression and adapting it to the individual resources and abilities of the patient, music therapy can be beneficial in activating and supporting mental and psycho-physical recover .

Detailed description: Students with developmental disabilities often have challenges in the areas of communication and social/emotional learning, which can lead to social isolation, problematic behaviors, and deficits in academic learning.These students have been found to respond well to the incorporation of music in intervention programs, in terms of both gains in communication skills and stronger social functioning . they respond more favorably and appropriately to music than other sensory stimuli

Eligibility criteria: Inclusion Criteria:

* 1.Age :3_7 2.Gender : both sex will be included in the study 3.IQ ≥75 4.children who will dignosed by an expert phoniatricist as having ASD

Exclusion Criteria:

* 1.Age \>3 \<7 2.IQ \<75 . 3. children having other cause of DELAYED LANGUAGE DEVELOPMENT

Primary outcomes:
measure: The Arabic Language test
timeFrame: Baseline,Change from Baseline at the end of 12 Months Music Therapy .
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gold C, Voracek M, Wigram T. Effects of music therapy for children and adolescents with psychopathology: a meta-analysis. J Child Psychol Psychiatry. 2004 Sep;45(6):1054-63. doi: 10.1111/j.1469-7610.2004.t01-1-00298.x.
citation: Geretsegger M, Fusar-Poli L, Elefant C, Mossler KA, Vitale G, Gold C. Music therapy for autistic people. Cochrane Database Syst Rev. 2022 May 9;5(5):CD004381. doi: 10.1002/14651858.CD004381.pub4.
Clinical trial NCT05093595: the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation
Official title: Trans-nasal ETT Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Craniotomy
Endotracheal Intubation Fixation
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.


Eligibility criteria: Inclusion criteria

* age 18-60 years old,
* ASA grade Ⅰ-Ⅱ,
* 18\<BMI\<24.

Exclusion criteria

* the intubation time was less than 5 hours,
* oral and facial skin damage,
* allergic to adhensive tapes,
* nasotracheal intubation,
* patients were edentulous.

Primary outcomes:
measure: the distance of tube movement
timeFrame: The participants will be followed from intubation to extubation, an expected average of 6 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Yue Yun
state: Liaoning
Study officials:
References:
Clinical trial NCT01365195: Effect of Ketamine on Postoperative Clinical Outcomes
Official title: Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colorectal Surgery
Keywords: opioid
Fentanyl
Anesthetic adjuvant
Pain management
Perioperative outcomes
Constipation
Ileus
Colorectal
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

Detailed description: Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

Eligibility criteria: Inclusion Criteria

1. Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
2. Willingness and ability to sign an informed consent document
3. No allergies to anesthetic or analgesic medications
4. 18 - 80 years of age
5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex

Exclusion Criteria

1. Inability to comprehend the pain assessment tools
2. Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
3. Patients with clinically-significant heart disease including arrhythmias and significant hypertension, brain aneurysms, prior history of cerebral vascular accident (CVA), or chronic renal insufficiency
4. Prior abdominal surgery
5. History of abdominal carcinomatosis
6. History of radiation enteritis;
7. Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
8. Patients with seizures
9. Morbid obesity (body mass index \>40)
10. Pregnant or lactating women
11. Subjects with a history of alcohol or drug abuse within the past 3 months
12. Any other conditions or use of any medication which may interfere with the conduct of the study
13. Prophylactic Nasogastric Tube (NGT) use
14. Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis
15. Individuals with asthma and/or thyroid diseases

Primary outcomes:
measure: Number of Participants With Opioid Consumption
timeFrame: 1 day
Secondary outcomes:
measure: Postoperative Pain
timeFrame: one day
measure: Participants With Nausea and Vomiting at PACU
timeFrame: 1 day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD., PhD
role: STUDY_DIRECTOR
References: