louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02658760: Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults
Official title: Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Femoral Fractures
Keywords: Femoral Fractures
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.


Eligibility criteria: Inclusion Criteria:

* Adults with femural fracture

Exclusion Criteria:

* Hypersensitivity to drugs
* Neurological diseases
* Coagulation abnormalities
* Infection at the site of block

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
measure: Respiratory depression
timeFrame: 24 hours
measure: Hypotension
timeFrame: 24 hours
measure: Baradycardia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Shahid Mohammadi hospital
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Nasim Abdi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241460: Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
Official title: A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Premature Ejaculation
Keywords: Premature Ejaculation
Lidocaine
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.

Detailed description: Promescent Lidocaine Spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital desensitizing drug products. In addition the evaluating the efficacy of treatment with Promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of Promescent for patients with premature ejaculation and their respective partners.

Eligibility criteria: Inclusion Criteria:

* Subject has provided written informed consent before screening.
* Subject is a male, 18 years of age or older.
* Subject meets the diagnostic criteria for premature ejaculation as defined by the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; 2000).
* Subject has a stable, monogamous, heterosexual relationship and sexually active for at least the last 6 months.
* Subject and partner are willing and able to engage in sexual intercourse.

Exclusion Criteria:

* Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e., always ejaculates prior to penetration).
* Subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation, anejaculation, painful ejaculation).
* In the opinion of the investigator, the subject has a condition or is in a situation that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to participate in the study.

Primary outcomes:
measure: Intravaginal Ejaculatory Latency Time (IELT) in seconds
timeFrame: Week 11
Secondary outcomes:
measure: Subjective distress
timeFrame: Week 3, 7, and 11
measure: Perception of improvement in premature ejaculation
timeFrame: Week 3, 7, and 11
measure: Perceived optimal dosage of treatment
timeFrame: Week 3, 7, and 11
measure: Adverse events/reactions to treatments
timeFrame: Week 11
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: Eugene Y Rhee, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02782260: Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dry Eye Syndromes
Pterygium
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2016-05-25
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: Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent.
* Ineligible or refused surgical excision, or had recurrence of pterygium following surgical excision
* Able to follow the study instructions, including application of the study product
* Agreement not to change the type of lubricating eye drops used (if any) during their participation in the study.
* Assessed as having at least pterygium stage 0-1 (pinguecula) based on Johnston, Williams \& Sheppard's classification for pterygium
* Concomitant dry eye symptoms, as determined by one or more of the following Subject interview (modified Ocular Surface Disease Index test), Tearing, Itch / foreign body sensation, Positive Fluorescein test, Positive TBUT test, Positive Tear meniscus test

Exclusion Criteria:

* Inability to provide informed consent
* Dry eye due to other factors
* Known lacrimal obstruction
* Contact lens wearers
* Non-corrected refraction
* Allergy or sensitivity to dipyridamole or excipients
* Use of dipyridamole in the last 6 months
* Other eye conditions (i.e. active ocular infection, herpes keratitis in last 6 months, corneal disorder abnormality excluding pterygium, history of ocular acne rosacea, blepharitis) which would impact results
* Diagnosis of ALS (Amyotrophic lateral sclerosis)
* Existing conditions which are contraindicated or precaution in use of dipyridamole or excipients
* Use of eye drops (other than ocular lubricants)
* Pregnant or breastfeeding
* Inability to apply the medical product or follow the study procedures
* Anything that the PI thinks would impact the trial

Primary outcomes:
measure: Assess the changes in dry eye parameters via a change in tear secretion rate
timeFrame: 6 months
measure: Assess the changes in dry eye parameters via reduction in dry eye symptomology.
timeFrame: 6 months
Secondary outcomes:
measure: A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06857760: Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort
Official title: Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Surgery
Keywords: nausea, thirst, comfort
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trials
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery.

Detailed description: Within the scope of this randomized controlled study, it is aimed to evaluate the effectiveness of ice, mouthwash and menthol lozenge interventions to provide effects on postoperative nausea, thirst and comfort in patients undergoing spinal surgery

Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent lumbar disc herniation (LDH) surgery
* LDH surgery patients who recieve general anesthesia
* The patients who were conscious
* The duration of surgery is between 0-3 hours

Exclusion Criteria:

* Patients who cannot understand and speak Turkish
* Allergic patients to menthol
* Patients who received spinal anesthesia
* Patients with lesions on the oral mucosa and lips
* Patients requiring intensive care after surgical intervention

Primary outcomes:
measure: Nausea
timeFrame: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
measure: Thirst
timeFrame: once before the application and 60, 120, 180 and 240 min. after arrival at the clinic
measure: Comfort
timeFrame: once before the application and 240 min. after arrival at the clinic
Secondary outcomes:
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya Şerefeddin Sabuncuoğlu Hospital
Study officials:
affiliation: Ondokuz Mayıs University
name: Özge İşeri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01561560: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Official title: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: DAILIES TOTAL1
contact lenses
myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.


Eligibility criteria: Inclusion Criteria:

* Sign written Informed Consent Document.
* Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
* Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
* Willing to wear study lenses for at least eight hours per day and at least five days per week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has not worn contact lenses before.
* Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
* Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last six months.
* Topical ocular or systemic use of antibiotics within seven days of enrollment.
* Pregnant or nursing women.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: End-of-day Comfort
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Camille Girault
role: STUDY_DIRECTOR
References:
Clinical trial NCT01310660: Evaluation of Levator Injuries Using Transvaginal Endosonography
Official title: Evaluation of Levator Injuries Using Transvaginal Endosonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childbirth Related Levator Injuries
Lead sponsor: Croydon University Hospital
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 269
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous

Brief summary: Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery.

In none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images.

3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles.

The relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term.

The principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women who have not delivered previously
2. Singleton pregnancy
3. Maternal age \> 18 years and
4. No previous pregnancies \>20 weeks of gestation
5. Ability to read and understand English.

Exclusion Criteria:

1. Pregnant women who have delivered previously
2. Multiple pregnancies

Primary outcomes:
measure: The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.
timeFrame: Antenatal, after delivery and postnatal
Secondary outcomes:
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Croydon University Hospital
state: Surrey
Study officials:
References:
Clinical trial NCT06066060: A DDI Study of JMKX000623 and Metformin Hydrochloride
Official title: Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Drug-Drug Interaction
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.

Detailed description: The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers

Eligibility criteria: Inclusion Criteria:

1. Healthy Chinese subjects aged 18-45 years, male or female;
2. Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI\<27.0 kg/m2;
3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
4. Able to provide written informed consent voluntarily.

Exclusion Criteria:

1. Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
2. History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
3. Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
4. Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
5. Other conditions unsuitable for the study confirmed by the investigator.

Primary outcomes:
measure: Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）
timeFrame: baseline through 4 days post-dose
measure: Maximum observed After Reaching steady state concentration (Css,max)
timeFrame: baseline through 4 days post-dose
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: baseline through 4 days post-dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Xiaojie Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090660: Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System
Official title: Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Novadaq Technologies ULC, now a part of Stryker
First posted: 2014-03-18
Enrollment: 20
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: This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence localization technique with a Laser fluorescence thoracoscope system.

The primary objective of this study is to prove the validity and safety of our novel fluorescent localization method with utilized ICG and novel near infra-red fluorescence videoscope system.


Eligibility criteria: Inclusion Criteria:

* Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.

Exclusion Criteria:

* Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
* Pregnant or potentially pregnant women.

Primary outcomes:
measure: Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.
timeFrame: Within 4 hours of ICG injection
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kazuhiro Yasufuku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05569460: Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models
Official title: Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Acute Pain
Risk Reduction
Keywords: Data Platform
Machine Learning
Postoperative Acute Pain
Lead sponsor: Guangdong Second Provincial General Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pain assessment was used by Numeric Rating Scale (NRS) score after surgery.

Brief summary: Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.


Eligibility criteria: Inclusion Criteria:

* Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery.

Exclusion Criteria:

* The basic information such gender, age, height, weight, and body mass index (BMI) were missing.
* Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.

Primary outcomes:
measure: Area under the curve
timeFrame: April 2020 to May 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
Study officials:
References: