louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01719848: Evaluation of Clinical Airway Assessments With a Gray Zone Approach
Official title: Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Laryngoscopy
Keywords: Physical examinations, Percentage of glottic opening(POGO)
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing general anesthesia for any surgery at Samsung medical center

Brief summary: Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity of pre-existing airway assessment tests and scoring system using a gray zone approach in patients undergoing general anesthesia required endotracheal intubation.

Detailed description: POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)

Eligibility criteria: Inclusion Criteria:

* 20 to 80 years old patients undergoing general anesthesia for any operation.

Exclusion Criteria:

* previous difficult airway history
* upper airway obstruction disease
* congenital disorders that are known to relate with difficult airway
* neurologic symptom associated with neck extension
* emergent operation

Primary outcomes:
measure: Percentage of glottic opening (POGO)
timeFrame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
citation: Min JJ, Kim G, Kim E, Lee JH. The diagnostic validity of clinical airway assessments for predicting difficult laryngoscopy using a grey zone approach. J Int Med Res. 2016 Aug;44(4):893-904. doi: 10.1177/0300060516642647. Epub 2016 Jun 6.
Clinical trial NCT06141330: Vitamin D Supplementation in Acne
Official title: Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Keywords: AcneVulgaris
Vitamin D
Lead sponsor: HITEC-Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 58
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:

• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.

Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.

Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included.

Exclusion Criteria:

* Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs)
* Those with obesity
* Individuals employing vitamin supplementation
* Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.

Primary outcomes:
measure: Efficacious
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Hitec-Ims
state: Punjab
Study officials:
References:
Clinical trial NCT01340248: A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Stable Angina
Keywords: food effect
pharmacokinetics
healthy male volunteers
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Between 20 aged and 50 aged in healthy adults
* Weight more than 55kg, IBW 20% within the range
* Agreement with written informed consent

Exclusion Criteria:

* Subject has hypersensitivity reaction or clinically significant history about investigational drug
* Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on
* Inadequate result of laboratory test

  * AST(SGOT) or ALT(SGPT) \> 1.5 x upper limit of normal range
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette \> 10 cigarettes per day)
* Creatinine clearance \< 80ml/min
* Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug
* Subject takes an abnormal meal which affect the ADME of drug
* Previously participated in other trial within 90 days
* Previously make whole blood donation within 60 days or component blood donation within 30 days
* Subject with positive reaction for reason of laboratory test result
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Primary outcomes:
measure: evaluation of pharmacokinetics
timeFrame: pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h
Secondary outcomes:
measure: evaluation of safety
timeFrame: from screenig to post-study visit
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university
state: Seoul
Study officials:
References:
Clinical trial NCT06132048: A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Official title: A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aims to assess the usability and safety of use of MuCopilot, a smartphone application that measures objective data on lung function, global exercise capacity and patient reported outcomes of patients with Cystic Fibrosis (CF). These data are collected during unsupervised digital tests performed in the patient's home environment between consultations.

The primary objective is to validate the usability and safety of use, in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk.

The study will include 17 CF patients and will be conducted in France. They will participate in 1 inclusion visit and 1 visit in-clinic (1h30).

Patients will be able to download the free MuCopilot mobile application. During the visit, patients will complete 3 digital tests in order to monitor CF functions (cough, dyspnea \& walking) and 1 symptom questionnaire.


Eligibility criteria: Inclusion Criteria:

* Aged ⩾ 18 years old
* Patients diagnosed with cystic fibrosis
* Enrolled in or benefiting of a Social Security program
* Having read the information sheet and signed the informed consent form
* Owning a personal smartphone which version is above 14 for IOS and 8 for Android included with a good internet connexion
* Able to read French and understand pictograms on a smartphone app

Exclusion Criteria:

* History of lung transplantation
* Pregnant women and women who are breastfeeding
* Any medical condition that could interfere with the proper conduct and results of the study (clinician's judgement)
* Illiterate in French
* Inability to use a smartphone or MuCopilot application
* Person under legal protection (including guardianship or curatorship)

Primary outcomes:
measure: Validation of usability (1)
timeFrame: 2 hours
measure: Validation of usability (2)
timeFrame: 2 hours
measure: Validation of no safety critical of use
timeFrame: 2 hours
measure: Validation of ease of use
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CRCM Mixte - Hôpital Charles Nicolle
Study officials:
References:
Clinical trial NCT03606148: SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions
Official title: A Prospective Comparison of SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Pancreatic Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above 18 years of age who underwent EUS-FNA for suspected pancreatic cancer based on imaging fingings.

Brief summary: The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. There is an advantage that the denaturation is small, the density of the cells is uniform, and the read area is small so that the read time can be shortened. Therefore, investigators plan to apply the SurePathTM test for pancreatic EUS-FNA specimens. Morphological comparative analysis is needed before completely replacing the existing classical smear test method. The aim of this study is to confirm that the SurePathTM is not inferior and is more accurate than the classical smear test.


Eligibility criteria: Inclusion Criteria:

* Patients who signed the agreement after the explanation
* Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)

Exclusion Criteria:

* Those who did not agree with the study
* Patients older than 18 years of age
* Serious mental patients
* Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, poorly controlled blood sugar)
* Pregnant women
* If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y)
* Patient with blood clotting abnormality
* If there is a risk of tract seeding after examination

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Sensitivity
timeFrame: 6 months after randomization
measure: Specificity
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Chun JW, Lee K, Lee SH, Kim H, You MS, Hwang YJ, Paik WH, Ryu JK, Kim YT. Comparison of liquid-based cytology with conventional smear cytology for EUS-guided FNA of solid pancreatic masses: a prospective randomized noninferiority study. Gastrointest Endosc. 2020 Apr;91(4):837-846.e1. doi: 10.1016/j.gie.2019.11.018. Epub 2019 Nov 20.
Clinical trial NCT06673030: Evaluation of the Effectiveness of New Management Techniques in Reducing Dental Anxiety for Children Undergoing Pulpotomy
Official title: Evaluation of the Effectiveness of Kaleidoscope and Tell-Show-Play-Doh in Reducing Dental Anxiety for Children Undergoing Pulpotomy in Primary Molars - a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Childhood dental anxiety, Behavior management.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.


Eligibility criteria: Inclusion Criteria: 1. Children attended the dental clinic for their first time.

2. Children aged between 4 to 6 years including both boys and girls. 3. Healthy Children with Frankl's behavior rating score 2,3 and 4 of Frankl's behavior rating scale and no prior dental experience.

4. Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.

- Exclusion Criteria: 1.Children with known significant visual impairments or psychological problems.

2. Children suffering from systemic diseases or special health care needs.

Primary outcomes:
measure: Assessment of behavior of the child before and during and after the pulpotomy procedures.
timeFrame: Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.
measure: Assessment of anxiety of the child before and after the pulpotomy procedures.
timeFrame: Pre-operatively and post-operatively at the end of the visit at the same visit with no follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura, Egypt.
country: Egypt
facility: Faculty of Dentistry, Mansoura university
Study officials:
References:
Clinical trial NCT00637130: Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost
Official title: Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 138
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: The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age related
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean Intraocular Pressure
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center at 1-888-451-3937
state: Texas
Study officials:
References:
Clinical trial NCT06990230: Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
Official title: Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of the Radiofrequency Transseptal Puncture System
Atrial Septum Puncture
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
First posted: 2025-05-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum.

Evaluation indicators:

Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.


Eligibility criteria: Inclusion Criteria:

Participants scheduled to undergo transseptal access interventional cardiology procedure; The subjects were informed of the nature of the study, understood the purpose of the clinical trial, voluntarily participated and signed an informed consent form.

Exclusion Criteria:

1. The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
2. subjects with ASD occluder or patch implantation;
3. hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
4. acute myocardial infarction within 4 weeks;
5. end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
6. history of cerebrovascular accident within 30 days;
7. pregnant and lactating women;
8. acute systemic infection or sepsis;
9. patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
10. atrial septal puncture within 3 months;
11. life expectancy less than one year;
12. The investigator judged that the patient had poor compliance and could not complete the study according to the requirements; Or other circumstances in which the researcher considers the subject to be unsuitable for the study

Primary outcomes:
measure: Success rate of atrial septum
timeFrame: It is expected to last 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Heayoung Medical Technology (Suzhou) Co., Ltd
state: Jiangsu
Study officials:
References:
Clinical trial NCT00754130: MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
Official title: A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Japanese Male or Female between 20 to 65 years of age
* Diagnosis of Type 2 Diabetes
* Patient being treated by diet and exercise alone

Exclusion Criteria:

* Patient has a history of Type 1 Diabetes
* Patient is being treated with glaucoma medications
* Patient has donated blood or participated in another clinical study in the past 12 weeks
* Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to 14 days after last dose of study drug
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 14 days after last dose of study drug
Secondary outcomes:
measure: Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941
timeFrame: Up to 72 hours after study drug administration
measure: Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941
timeFrame: Up to 72 hours after study drug administration
measure: Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941
timeFrame: Up to 72 hours after study drug administration
measure: Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)
timeFrame: Up to 72 hours after study drug administration
measure: Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941
timeFrame: Up to 72 hours after study drug administration
measure: Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr
timeFrame: Day 5 and Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: