louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05762003: Czech Pharmaco-epidemiological Study on Disease Modifying Drugs
Official title: Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: IMPULS Endowment Fund
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 17478
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from primary patient care and included in patient registry ReMuS.

Brief summary: Multiple sclerosis (MS) is a severe autoimmune disease that affects mainly young individuals. It is estimated that there are 17-20,000 affected persons in the Czech Republic.

Currently, MS remains an incurable but treatable disease. As of now, there are many drugs that are able to reduce the inflammatory part of the disease that prevails in its initial phases. The problem is the great variability of the severity of clinical course (from relatively benign to severe malignant courses) and different responses of particular patients to particular drugs. A personalized approach with long life monitoring and adjustment of treatment according to the activity of the disease is essential.

From this point of view registries represent one of the most important source of long term data that is used for evaluation of effectiveness and safety of different drugs in areal life setting.

The objective of this study is to compare effectiveness and safety profile in MS patients treated with a different Disease Modifying Drugs (DMDs) and Ocrelizumab using data from the real clinical practice from the Czech national multiple sclerosis patient registry (ReMuS).


Eligibility criteria: Inclusion Criteria:

* Each participant must provide informed consent to registry ReMuS in accordance with local regulations
* The patient is treated by any kind of DMDs
* Confirmed diagnosis of multiple sclerosis

Exclusion Criteria:

* Patient withdrawal of informed consent to registry ReMuS

Primary outcomes:
measure: Effectiveness in relapses
timeFrame: 1 year from DMD initiation
measure: Effectiveness EDSS
timeFrame: 1 year from DMD initiation
Secondary outcomes:
measure: Description of baseline characteristics of patients treated by different DMDs at the time of DMT initiation
timeFrame: Baseline
measure: Description of termination of different DMDs treatment
timeFrame: Day of DMD termination, assessed up to 15 years
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: IMPULS Endowment Fund
Study officials:
References:
Clinical trial NCT01535443: Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Official title: Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Cataract
Keywords: PRO-155
Ocular NSAIDs
Safety and tolerability
Ocular Inflammation
Ocular Paint
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Detailed description: A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female.
* Age ≥ 18 years old at screening visit

Exclusion Criteria:

* Any ocular or systemic condition.
* Patient with one blind eye.
* Visual acuity of 20/40 in any eye.
* Use of ocular or systemic medications.
* Contraindications or sensitivity to any component of the study treatments.
* Contact lens users.
* Ocular surgery within the past 3 months..
* Women who were not using an effective means of contraception or who were pregnant or nursing.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Primary outcomes:
measure: Visual Acuity
timeFrame: 10 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 10 days
measure: Findings in Posterior Segment
timeFrame: 10 days
measure: Intraocular Pressure (IOP)
timeFrame: 10 days
measure: Hyperemia
timeFrame: 10 days
measure: Burning
timeFrame: 10 days
measure: Tearing
timeFrame: 10 days
measure: Foreign Body Sensation
timeFrame: 10 days
measure: Photophobia
timeFrame: 10 days
measure: Chemosis
timeFrame: 10 days
measure: Corneal Damage by Fluorescein Staining Test
timeFrame: 10 days
measure: Corneal Damage by Lissamine Green Staining Test
timeFrame: 10 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad Medica "Grupo Pediátrico"
state: Jalisco
Study officials:
affiliation: Unidad Medica "Grupo Pediátrico"
name: Alfredo Lizarraga-Corona, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Department. Laboratorios Sophia SA de CV
name: Leopoldo M Baiza-Duran, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00895843: Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery
Official title: Protective Analgesia Using Bupivacaine and Conventional Release Ibuprofen Versus Bupivacaine and Sustained Release Ibuprofen for Postoperative Pain Relief in Patients Undergoing Third Molar Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Wisdom Tooth
Keywords: Third molar
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2009-05-08
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.

Detailed description: The aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia.

The primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia.

The secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* healthy male and female patients aged 18 years and over
* patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal

Exclusion Criteria:

* history of allergy to NSAIDs
* pregnant
* history of GI disease
* history of bleeding disorders
* alcohol dependancy
* drug abuse

Primary outcomes:
measure: Number of Patients Needing Rescue Medication
timeFrame: At 6 hours
Secondary outcomes:
measure: Mean Pain Intensity
timeFrame: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery
measure: Time to Rescue
timeFrame: Between 30mins and 48 hours
measure: Pain Control/Relief
timeFrame: 48 hours after surgery (end of study)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Central Manchester and Manchester Children's NHS University Hospitals
state: Lancashire
city: Manchester
country: United Kingdom
facility: Central Manchester NHS Foundation Trust
state: Lancashire
Study officials:
affiliation: University of Manchester
name: Paul Coulthard, BDS FDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167543: Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Dental Erosion
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2010-07-22
Enrollment: 79
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Specialty Clinics and General Pediatric Clinics at the University of California, San Francisco

Brief summary: This study investigates the prevalence and pathophysiology of dental and periodontal involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the prevalence of oral disease in children with and without a diagnosis or symptoms/signs of GERD in a cross-sectional study. Secondary objectives are to examine factors that might lead to the pathogenesis of the dental and periodontal lesions observed in this group of subjects.

The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having symptoms or signs of GERD have a significantly higher amount of dental erosions in comparison to a matched control group.

Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering capacity.


Eligibility criteria: Inclusion Criteria:

* Ages 9.0 to 18.0 years, of either gender
* Able to give verbal / written assent / consent themselves and/or informed consent from a parent/guardian
* Willing to comply with all study procedures and protocols,
* Willing to get dental photographs and impressions taken
* Willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form

Exclusion Criteria:

* Subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
* Other conditions that may decrease the likelihood of adhering to study protocol,
* Subjects who will leave the area and are unable to complete the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Dental School
state: California
Study officials:
References:
Clinical trial NCT06743243: Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia
Official title: Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ordinary Disorder Needed Planned Surgery and General Anesthesia
Keywords: K-CAB
K-CAB OD tab.
P-CAB
Famotidine
Tegoprazan
general anesthesia
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Korea University Guro Hospital
name: Chung-Ang University Gwangmyeong Hospital
name: HK inno.N Corporation
name: Eunpyeong St. Mary's Hospital, The Catholic University of Korea
First posted: 2024-12-19
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare gastric pH right after endotracheal intubation for general anesthesia in patients pretreated with tegoprazan, famotidine, or placebo.

Detailed description: This clinical trial is a prospective, randomized, double-blind, multicenter, investigator-initiated trial that aims to demonstrate the preventive effect of tegoprazan on preoperative aspiration in patients scheduled to undergo surgery using general anesthesia.

Subjects who meet the inclusion/exclusion criteria will be randomly assigned to the tegoprazan administration group (Group T), famotidine administration group (Group F), or placebo administration group (Group C) in the same ratio of 1:1:1.

Eligibility criteria: Inclusion Criteria:

1. Has a plan to undergo surgery with general anesthesia with inhalation or total Intravenous
2. Subjects aged between 20 and 69 years
3. ASA classification I - III

Exclusion Criteria:

1. Conduct Emergency surgery
2. BMI(Body Mass Index) ≥ 35
3. Has a history of drug abuse or depandency.
4. Has a history of Anesthetic allergy
5. Has a plan to undergo resection(gastric cancer, esophageal cancer)

Primary outcomes:
measure: Gastric pH right after endotracheal intubation
timeFrame: right after endotracheal intubation
Secondary outcomes:
measure: Change of oral, esophageal and gastric pH
timeFrame: oral pH(before anesthesia, endotracheal intubation 30 minutes after surgery started, right after surgery end, extubation, 30minutes after enter the postanesthesia care unit), esophageal and gastric pH(right after intubation)
measure: Gastric volume evaluated by Ultrasound
timeFrame: before anesthesia, right after end of surgery, 30 minutes after enter the postanesthesia care unit
measure: Risk of aspiration(pH < 2.5, Gastric volume > 0.4mL/kg) and frequency of complications(aspiration etc.)
timeFrame: before anesthesia, right after intubation, 30 minutes after surgery started, right after surgery end, extubation, 30 minutes after enter the postanesthesia care unit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center, Guro Hospital
Study officials:
References:
Clinical trial NCT00000243: Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Official title: Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

Detailed description: Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for opioid dependence

Exclusion Criteria:

* Significant medical or psychiatric illness

Primary outcomes:
measure: Physiological effects
measure: Analog rating scale for drug effects
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02000843: Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium
Official title: Tympanoplasty -- Conchal Cavum Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforation of Eardrum.
Keywords: perforation
tympanoplasty
conchal cavum approach
perichondrium/ cartilage
scar
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years.

The new approach has been used in patients after informed consent was obtained from each patient.

Detailed description: From 2010 to 2013, a total of 96 patients had the procedure. The data are entered, and analyzed. All identifiable information would be hidden.

This application is to obtain patients' consent for release and publication of the data. Patients would be assured their identities are protected.

Eligibility criteria: Inclusion Criteria:

* All patients with informed consent

Exclusion Criteria:

* Patients without consent

Primary outcomes:
measure: success rate of repair of eardrum
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Christopher Man
state: British Columbia
Study officials:
affiliation: UBC
name: Christopher Man, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamad SH, Khan I, Hussain SS. Is cartilage tympanoplasty more effective than fascia tympanoplasty? A systematic review. Otol Neurotol. 2012 Jul;33(5):699-705. doi: 10.1097/MAO.0b013e318254fbc2.
citation: Man SC, Nunez DA. Tympanoplasty--conchal cavum approach. J Otolaryngol Head Neck Surg. 2016 Jan 6;45:1. doi: 10.1186/s40463-015-0113-3.
Clinical trial NCT00668343: Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: edss attack
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient with relapsing remitting multiple sclerosis taking avonex are included in this double blind randomized control trial. Simvastatin is compared to placebo. end points of edss , total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.


Eligibility criteria: Inclusion Criteria:

1. edss\<5
2. \>=1 attack in last year

Exclusion Criteria:

1. \>2 attacks in study
2. drug complication

Primary outcomes:
measure: attack number
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sanaz Ahmadi
Study officials:
affiliation: TUMS
name: Mansooreh Togha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Togha M, Karvigh SA, Nabavi M, Moghadam NB, Harirchian MH, Sahraian MA, Enzevaei A, Nourian A, Ghanaati H, Firouznia K, Jannati A, Shekiba M. Simvastatin treatment in patients with relapsing-remitting multiple sclerosis receiving interferon beta 1a: a double-blind randomized controlled trial. Mult Scler. 2010 Jul;16(7):848-54. doi: 10.1177/1352458510369147. Epub 2010 May 20.
Clinical trial NCT06322043: Evaluation of Safety of Filler Injection in Subcutaneous Tissues
Official title: A Single-Arm Pilot Study to Evaluate the Safety of Adipearl Injection in the Subcutaneous Tissues of Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Volume Deficiency
Lead sponsor: Volumina Medical S.A.
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 18
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Adipearl is an injectable filler intended to be injected subcutaneously.


Eligibility criteria: Inclusion Criteria:

* Subject having given freely and expressly informed consent;
* Subject deemed by the Investigator to be medically fit for injection of the product;
* Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject participating to another research study.
* Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.

Primary outcomes:
measure: Safety of Investigational Medical Device
timeFrame: 6-Months
Secondary outcomes:
Other outcomes:
Locations:
city: Crans-Montana
country: Switzerland
facility: Summit Clinic
Study officials:
References:
Clinical trial NCT00560443: RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
Official title: Randomized Controlled Trial on Effectiveness of Ketorolac and Tramadol in Not Compound Fractures of Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fracture
Pain
Keywords: bone fracture
ketorolac
tramadol
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2007-11-19
Enrollment: 133
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:

* ketorolac 0,5 mg/kg (1 drop every 2 Kg)
* tramadol 2,5 mg/Kh (1 drop every 2 Kg)

Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.

The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects


Eligibility criteria: Inclusion Criteria:

* Children 4-17 years old with not compound bone fracture presenting in emergency room

Exclusion Criteria:

* Compound fracture
* Occurring pain still treated
* Contraindicated ketorolac or tramadol use
* Informed consensus not obtained

Primary outcomes:
measure: estimation of pain reduction in every arm of the trial with linear 1-10 pain scale or for children 4 - 6 years old with analogic MacGrath type scale
timeFrame: 6 hours (or until the end of procedures)
Secondary outcomes:
measure: comparison between the two groups on effectiveness on pain, measured with linear and analogic scale (see above)
timeFrame: 6 hours or until the end of procedures
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Edoardo Guglia, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.