louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06932822: Mental Imagery to Enhance Procedural Skills in Peripheral Venous Catheterization
Official title: Mental Imagery to Enhance Procedural Skills in Peripheral Venous Catheterization: A Randomized Simulation Study in Medical Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Venous Catheterization
Simulation Training
Mental Imagery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 96
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: Peripheral venous catheter insertion has a slow learning curve, and is rarely performed by medical students. Most medical interns do not master this procedure independently at the start of their residency.

It's a painful procedure for the patients, and therefore unsuitable for "in vivo" training at the patient's bedside For this type of procedure, it would appear necessary to develop alternative teaching methods, as well as pedagogical tools that can modify the learning curve to make it faster.

Mental imagery is a technique that involves creating vivid, detailed mental images in the mind. It is often used in a variety of contexts, such as mental preparation, stress management, learning or goal achievement Initially used in mental preparation for sports, it made its appearance as a pedagogical tool in the medical field in the 2010s, with several studies demonstrating its value in learning procedural gestures (training in laparoscopic surgery, cystoscopy).

The aim of our study is to investigate the impact of a mental imagery session on peripheral venous catheter placement success in 5th-year medical students, on a simulation mannequin.


Eligibility criteria: Inclusion Criteria:

* 5th-year medical student at the Nîmes medical school taking part in the peripheral venous catheter insertion training workshop
* No other conditions required.

Exclusion Criteria:

* None

Primary outcomes:
measure: First puncture success rate
timeFrame: 30 minutes
Secondary outcomes:
measure: Revised Mental Imagery Questionnaire (MIQ)-3 variation
timeFrame: 30 minutes
measure: Revised Mental Imagery Questionnaire (MIQ)-3 comparison
timeFrame: 30 minutes
measure: Puncture number
timeFrame: 30 minutes
measure: Procedure complications
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00361322: Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
Official title: Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.


Eligibility criteria: Inclusion Criteria:

* mild to moderate acne vulgaris;
* at least 5 lesions on the face;
* a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris.

Exclusion Criteria:

* acne that was primarily truncal, nodular, or due to secondary causes/internal disease;
* pregnancy, breastfeeding, or intention to become pregnant;
* another dermatological disease of the face;
* significant systemic disease;
* any drug/alcohol addiction;
* interacting medication;
* known hypersensitivity to study medications;
* history of chronic disease treated with medications which might affect acne condition and treatment outcome (e.g. corticosteroids, lithium, isoniazid, anti-androgens, phenytoin, phenobarbital) in the preceding month

Primary outcomes:
measure: Lesions count at the baseline (week 0)
measure: Lesions count at the end of study (week 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Vera Leibovici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Arie Ingber, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hebrew University of Jerusalem, Jerusalem, Israel
name: Elka Touitou, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907722: The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI
Official title: The 3q25 rs2305619 Polymorphism is Associated With Coronary Microvascular Obstruction Following Primary Angioplasty for Acute ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Microvascular Coronary Artery Disease
Lead sponsor: Indonesian Cardiovascular Research Center
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with STEMI symptom onset \<12h admitted to the ED and planned for primary PCI

Brief summary: The investigators enrolled 217 patients with acute STEMI undergoing primary PCI. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit.

Detailed description: The investigators enrolled 217 patients with acute STEMI undergoing primary PCI in a tertiary care academic cardiovascular center. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit. The primary outcome of the study was the incidence of coronary microvascular obstruction defined as thrombolysis in myocardial infarction (TIMI) grade \<3 flow after primary PCI or TIMI grade 3 flow with myocardial blush grade 0 or 1. Patients were grouped based on the genotypic variants (AA, AG and GG). The primary outcome was compared among the three variants, as well as the PTX3 concentration and 30-day mortality.

Eligibility criteria: Inclusion Criteria:

* Patients with acute STEMI with symptom onset \<12 h and treated by primary PCI

Exclusion Criteria:

* STEMI patients who received fibrinolytic therapy

Primary outcomes:
measure: Incidence of microvascular obstruction
timeFrame: Immediate after pci
Secondary outcomes:
measure: Incidence of mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Indonesian Cardiovascular Research Center
state: DKI Jakarta
Study officials:
affiliation: Indonesian Cardiovascular Center
name: Surya Dharma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664222: Spironolactone and Insulin Resistance in Chronic Heart Failure (CHF)
Official title: Effects of Spironolactone on Insulin Resistance in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Stable Heart Failure
Keywords: heart failure
insulin resistance
inflammatory cytokine
spironolactone
furosemide
Lead sponsor: Tottori University Hospital
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Detailed description: Diuretics is useful in CHF patients. On the other hand, they deteriorate glucose metabolism. Therefore, the purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Eligibility criteria: Inclusion Criteria:

* chronic stable heart failure

Exclusion Criteria:

* renal dysfunction or under treatment with antidiabetic agents

Primary outcomes:
measure: insulin resistance
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02573922: Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Official title: Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: constipation
opioid
Oxycodone
Oxycodone-naloxone
spine surgery
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, the primary aim was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced opioid induced constipation in patients with or without chronic opioid treatment undergoing spine surgery.


Eligibility criteria: Inclusion Criteria:

* BMI 17 - 35 kg/m2
* elective spine surgery
* informed consent obtained

Exclusion Criteria:

* allergy to the used drugs
* other contraindication to oxycodone medication
* no informed consent

Primary outcomes:
measure: opioid induced constipation
timeFrame: from the surgery up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital
name: Merja Kokki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuronen M, Kokki H, Nyyssonen T, Savolainen S, Kokki M. Life satisfaction and pain interference in spine surgery patients before and after surgery: comparison between on-opioid and opioid-naive patients. Qual Life Res. 2018 Nov;27(11):3013-3020. doi: 10.1007/s11136-018-1961-x. Epub 2018 Aug 2.
citation: Kokki M, Kuronen M, Naaranlahti T, Nyyssonen T, Pikkarainen I, Savolainen S, Kokki H. Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment. Adv Ther. 2017 Jan;34(1):236-251. doi: 10.1007/s12325-016-0456-9. Epub 2016 Dec 5.
Clinical trial NCT03344822: Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients
Official title: Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: 68Ga-PSMA PET
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
Primary purpose: DIAGNOSTIC

Brief summary: Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.

The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.


Eligibility criteria: Inclusion Criteria:

* high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline

Exclusion Criteria:

* contraindication of 68Ga-PSMA PET-CT

Primary outcomes:
measure: percentage of modification of management intent
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central hospital Nancy
Study officials:
References:
Clinical trial NCT04211922: Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Official title: A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: ALK-positive Non-small Cell Lung Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 4
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 main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

Detailed description: The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.

The study is a non-control study.

The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* Evidence of positive ALK.
* Patients must have demonstrated progression during or after crizotinib treatment.
* Age 18 years or older at the time of informed consent.
* Eastern cooperative oncology group performance status (ECOG PS) of 0-2
* At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
* Willingness and ability to comply with the trial and follow-up procedures.

Exclusion Criteria:

* chemotherapy, radiation therapy, immunotherapy within 4 weeks.
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
* Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion

Primary outcomes:
measure: Objective response rate (ORR) based on independent radiology review
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival (PFS) as assessed by independent radiology review and investigator
timeFrame: 36 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00454922: Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
Official title: Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
patient educator
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2007-04-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. The investigators' specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. The investigators' hypothesis is that patient education and counseling delivered by a trained glaucoma educator, through both planned visits and telephone contacts, will increase adherence to topical glaucoma therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma.
* Currently on monotherapy drop treatment for glaucoma.
* Age \> 18 years.
* Patient has presented for care at the Rocky Mountain Lions Eye Institute Glaucoma Center.

Exclusion Criteria:

* Inability to independently administer eye drops due to physical disability as reported by the patient.
* Cognitive impairment that would interfere with the ability to self-administer medications as evidenced by a TICS score \< 16.
* Patients who demonstrate \> 80% adherence to glaucoma treatment during the 30 day run-in period.
* It is anticipated that the patient will require glaucoma surgery within the next six months.

Primary outcomes:
measure: primary outcome is adherence.
timeFrame: 6 months
Secondary outcomes:
measure: differences between patients randomized to standard of care and education intervention.
timeFrame: 6 months
measure: differences between dropouts and non-dropouts.
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
Study officials:
affiliation: Rocky Mountain Lions Eye Institute
name: Malik Y. Kahook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06732622: Laser Acupuncture for Idiopathic Bell's Palsy
Official title: Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bell Palsy
Keywords: Bell's Palsy
Laser acupuncture
Photobiomodulation
RCT
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.

Detailed description: This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Prednisolone. Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).

Clinical outcome measure comprised the House-Brackmann grading system, Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24.

Eligibility criteria: Inclusion Criteria:

* 1. Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.

Exclusion Criteria:

* 1. Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases. 2. Planning for pregnancy, those in pregnancy, or those who were lactating. 3.Bell's Palsy patients who have a disease course of more than 8 weeks.

Primary outcomes:
measure: House Brackmann Grading System (HB)
timeFrame: Baseline, weeks 2, 4, 6, 8, 12 and 24
Secondary outcomes:
measure: Sunnybrook Facial Grading Scale (SB Grading)
timeFrame: Baseline, weeks 2, 4, 6, 8, 12 and 24
measure: Facial Disability Index (FDI)
timeFrame: Baseline, weeks 2, 4, 6, 8, 12 and 24
measure: Facial Clinimetric Evaluation Scale (FaCE Scale)
timeFrame: Baseline, weeks 2, 4, 6, 8, 12 and 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Beijing TongRen Hospital, Capital Medical University Beijing, China
state: Beijing
Study officials:
References:
Clinical trial NCT00366522: Study Evaluating LXR-623 in Healthy Subjects
Official title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LXR-623 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Healthy
healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of a single dose of LXR-623 in healthy subjects.


Eligibility criteria: Inclusion:

* Healthy, men or women, aged 19-50 years

Exlcusion:

* Use of any investigational or prescription drug within 30 days before study start
* Any clinically imprtant medical disease or abnormal laboratory test results

Primary outcomes:
measure: Safety and Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: