louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02189863: Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
Official title: Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Driving Simulator
Air Optix Aqua
AOAMF
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 33
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The overall objective of this study is to compare the effect on simulated driving performance of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.

Detailed description: In this crossover study, subjects wore lotrafilcon B MV (AOAMV) and lotrafilcon B MF (AOAMF) soft contact lenses as randomized for 2 weeks each. Subjects were assessed using a standardised driving simulation for each of the two treatments. A fresh pair of lenses was dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD) and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional same-day assessment. Habitual correction was worn for an acclimatization drive in the driving simulator during Period 1.

Eligibility criteria: Inclusion Criteria:

* Current soft contact lens wearers (for 1 month or more) with distance spherical power requirements of +1.00 to + 4.00 diopters (D) or -1.00 to -10.00D, and who have never tried and then failed in monovision or AOAMF.
* Medium to high presbyopia, i.e. spectacle add requirement of +1.50D or more.
* Astigmatism, if present, ≤1.00D in both eyes.
* Distance visual acuity (VA) correctable to 20/30 (+0.2 logMAR) in both eyes.
* Within the normal ranges for binocular vision for distance (8Δ exophoria, ≤8Δ esophoria), vertical phoria = 1.5Δ hypo or hyper.
* Full United Kingdom driving license held for at least 3 years, with at least 2000 miles driven per year.
* Willing to wear study lenses at least 5 days per week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Existing AIR OPTIX® Multifocal CL user.
* Sphere requirement in the range +0.75 to -0.75D in both eyes.
* Previous refractive surgery.
* Ocular/systemic medical condition or medical treatment contra-indicating contact lens wear or driving simulation.
* Participation in a clinical study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)
timeFrame: Week 2, each period
Secondary outcomes:
measure: Standard Deviation of Lateral Positioning
timeFrame: Week 2, each period
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Manager, Global Medical Affairs, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06798363: Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma
Official title: Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma： a Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Infantile Hemangioma
Keywords: Infantile hemangioma, ulcer, propranolol
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).

Detailed description: Infantile hemangioma (IH) is the most common benign tumor in infants, with an estimated prevalence of 4%-5%. Although most IH resolves over time without serious sequelae, a significant proportion can lead to serious complications such as ulcers. Propranolol is considered to be an effective treatment modality for ulceration IH, and there are retrospective studies suggesting that starting treatment at a low dose is safe and effective. However, due to the lack of prospective study, the effectiveness of different doses of propranolol for initiating treatment of ulceration IH is unknown. Therefore, a prospective study of ulceration IHs in Chinese children was conducted to clarify its efficacy.

Eligibility criteria: Inclusion Criteria:

1. all patients with ulcer IH;
2. children with ulcer IH treated with propranolol.

Exclusion Criteria:

1) children with ulcer IH who received other therapeutic interventions were excluded; 2) Children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons.

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Primary outcomes:
measure: Time to ulcer healing
timeFrame: 1.5 years
Secondary outcomes:
measure: The resolution of IH at month 6 after treatment
timeFrame: 1.5 years
measure: adverse events
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03426163: Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery
Official title: Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Injuries
Keywords: virtual reality
knee
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique.

Detailed description: The primary outcome of the study is APAIS score assessed at 24 hours postoperation. Experimental VR group will be applied with virtual reality transformed knee MRI whereas no interverntion group will be applied with traditional knee MRI. MRI will be transformed to virtual reality images by Mesh rendering technique.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective knee arthroscopy surgery

Exclusion Criteria:

* Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)

Primary outcomes:
measure: The Amsterdam perioperative anxiety and information scale (APAIS) score
timeFrame: postoperatively at 24 hours
Secondary outcomes:
measure: Visual analogue scale (VAS) for satisfaction
timeFrame: postoperatively at 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University Seoul Hospital
name: JIN KYU M LEE
role: STUDY_CHAIR
References:
citation: Yang JH, Ryu JJ, Nam E, Lee HS, Lee JK. Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Arthroscopy. 2019 Aug;35(8):2394-2399. doi: 10.1016/j.arthro.2019.02.037.
Clinical trial NCT01418963: A Study of RO5285119 in Healthy Volunteers
Official title: A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.


Eligibility criteria: Inclusion Criteria:

* Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)
* Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
* Female subjects must be surgically sterile or postmenopausal
* Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing

Exclusion Criteria:

* History or presence of any significant disease or disorder
* Positive for hepatitis B. hepatitis C or HIV infection
* History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse
* Participation in an investigational drug or device study within 3 months prior to first dosing
* Donation of blood within 3 months prior to first dosing
* Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day)
* History of hypersensitivity or allergic reactions
* Part 2: Contraindications for MRI scans

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration - time curve (AUC)
timeFrame: up to 5 weeks
measure: Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS
timeFrame: up to 5 weeks
measure: Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)
timeFrame: up to 5 weeks
measure: Pharmacodynamics: Functional Magnetic Resonance Imaging
timeFrame: up to 5 weeks
measure: Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)
timeFrame: up to 5 weeks
Other outcomes:
Locations:
city: Rennes
country: France
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16.
Clinical trial NCT05248763: Taiwan Cancer Moonshot Project
Official title: Taiwan Cancer Moonshot Project: 1. Next-generation Pathway of Taiwan Cancer Precision Medicine (Subjective Aim 1- Taiwan Cancer Moonshot Project); 2. Development of Novel Treatments for Major Diseases (Subproject 5 - Multiomic Big Data-based Intelligent Navigation System for Precision Oncology)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm of Body of Stomach in Situ
Keywords: lung cancer
breast cancer
gastric cancer
pancreatic cancer
ovarian cancer
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2022-02-21
Enrollment: 4190
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer in Taiwan

Brief summary: The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform.

Detailed description: Multiomic integrative analysis is an effective strategy to facilitate the investigation of molecular mechanism, cause, and early intervention of specific diseases. Gastric cancer is specifically chosen for our research target to decrease its incidence and improve survival. To increase precision diagnosis, prognosis and precision therapy, patients from Taiwan are selected as cohort subjects. The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform. Genome, transcriptome, genomic methylation, proteomics, and post-translational modification will be used to construct a map for determine the in-depth carcinogenesis of gastric cancer and strategies for cancer early diagnosis, prevention, and targeted treatments.

Eligibility criteria: Inclusion Criteria:

* lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer

Exclusion Criteria:

* other cancer types

Primary outcomes:
measure: Collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data
timeFrame: Through study completion, an average of 2 to 3 year
Secondary outcomes:
measure: Differential expressed genes and proteins in tumor
timeFrame: Through study completion, an average of 4 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Distinguished Research Fellow
name: Yu-Ju Chen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01776463: A Healthy Subject Study With Z-360 and Placebo
Official title: A Single Centre, Randomized, Double-blind, Ascending Dose, Placebo-controlled, and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Z-360 and Placebo in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Z-360
Japanese
pK
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 43
Sex: MALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.

Detailed description: This is a single centre, randomized, double-blind, placebo-controlled, parallel-group, and food effect study.This is three parts study. The purpose of the first part (Part 1) is the evaluation of the safety, tolerability, and pharmacokinetics after single ascending doses of Z-360.The second part (Part 2 ) is the evaluation of the pharmacokinetics of food effect of Z-360.The third part (Part 3) is the evaluation of the safety, tolerability, and pharmacokinetics after multiple ascending doses of Z-360.

Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects between 20 to 49 years of age inclusive
2. Body mass index (BMI) within the range 17.6 to 26.4 kg/m2 inclusive
3. The subject is capable of giving written informed consent prior to admission into this study

Exclusion Criteria:

1. History or presence of drug hypersensitivity, drug dependence, narcotic dependence or alcohol dependence
2. History or presence disease of digestive, liver, kidney, blood, cardiovascular, neuropsychiatric which may affect participation or results of this study
3. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, HIV antigen antibody or Serological test for syphilis
4. Use of any medication within 1 week prior to dosing
5. Received any investigational drugs with new active ingredients within 16 weeks prior to dosing the study or received any investigational drugs in other clinical studies within 12 weeks
6. Whole blood collection exceeding 200 mL within 4 weeks, apheresis within 2 weeks, or blood withdrawal exceeding 400 mL within 12 weeks (blood donation, etc) prior to dosing
7. Others, patients who are unfit for the study as determined by the attending physician

Primary outcomes:
measure: General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: To evaluate the pharmacokinetics of single and multiple doses of Z-360 in healthy subjects
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: Sumida
state: Tokyo
Study officials:
affiliation: Sumida
name: Eri Sato, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03401463: Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
Official title: Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Diseases
Respiratory Tract Infections
Pneumonia, Ventilator-Associated
Ventilator-Induced Lung Injury
Keywords: endotracheal tube cuff pressure
Ventilator-Induced Lung Injury
traning
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include patients staying in the intensive care unit, requiring ventilation of the artificial airways in the form of endotracheal or tracheostomy tube. Patients will be over 18 years of age.
Primary purpose: PREVENTION

Brief summary: There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients.

Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct training for medical and nursing staff. After the training, ETCP will be measured every 8 hours.

The aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal ETCP.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients intubated in a medical intensive care unit

Exclusion Criteria:

* Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients

Primary outcomes:
measure: monitoring of cuff pressures
timeFrame: 1 year
Secondary outcomes:
measure: preventing complications of incorrect pressure in tracheal cuff
timeFrame: 5 years
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: University Hospital
Study officials:
References:
Clinical trial NCT00168363: Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 207
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: This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* ocular hypertension or glaucoma in both eyes
* currently treated with brimonidine
* requires IOP-lowering therapy in both eyes

Exclusion Criteria:

* uncontrolled systemic disease
* known allergy or sensitivity to brimonidine

Primary outcomes:
measure: lowering of intraocular pressure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cantor LB, Safyan E, Liu CC, Batoosingh AL. Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial. Curr Med Res Opin. 2008 Jul;24(7):2035-43. doi: 10.1185/03007990802199287. Epub 2008 Jun 4.
Clinical trial NCT04919863: Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
Official title: A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: ATXA Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: Hammersmith Medicines Research
First posted: 2021-06-09
Enrollment: 79
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.


Eligibility criteria: Inclusion Criteria:

* A body mass index (BMI) in the range 18.0-30.0.
* Ability \& willingness to provide written consent.

Exclusion Criteria:

* Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
* History of bleeding disorders, coagulation variables or abnormal blood cell count.
* History of chronic illness.
* Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
* History of adverse reaction or allergy to any drug.
* Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
* History of drug or alcohol abuse
* Smoker or use of nicotine-containing products
* Blood pressure or heart rate at screening outside normal ranges.

Primary outcomes:
measure: Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.
timeFrame: Up to 48-hour post-dose.
measure: Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers.
timeFrame: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
measure: Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers.
timeFrame: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Secondary outcomes:
measure: Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers.
timeFrame: Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Hammersmith Medicines Reserach
name: Malcolm Boyce, MD
role: PRINCIPAL_INVESTIGATOR
References: