louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00350155: Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel
Official title: A 16-Day, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Trial Comparing Lumiracoxib 100mg o.d. With Naproxen 500 mg b.i.d. Plus Omeprazole 20mg o.d. and Placebo in Healthy Volunteers to Investigate on the Safety and Tolerability of Lumiracoxib in the Small Bowel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects

Exclusion Criteria:

* Evidence of cardiovascular, hepatic, gastrointestinal or renal disorders
* Hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome
* Smokers

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
Secondary outcomes:
measure: Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
measure: Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy
measure: Total number of small bowel lesions detected by video capsule endoscopy
measure: Value of small bowel inflammation (as measured by calprotectin test)
measure: Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars)
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References:
Clinical trial NCT00968955: Effect of Local Infiltration Analgesia in Total Hip Arthroplasty
Official title: Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: Postoperative acute pain
Total hip arthroplasty
Local infiltration analgesia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2009-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.

The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.

Detailed description: In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.

Eligibility criteria: Inclusion Criteria:

* Elective total hip arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding
* Opioid intolerance
* Obesity defined as BMI\>40 kg/m2
* Diabetic neuropathy and rheumatoid arthritis

Primary outcomes:
measure: Postoperative pain scores on the Visual Analog Scale (during walking)
timeFrame: up to 8 hours
Secondary outcomes:
measure: Additional analgetics measured as cumulated amount i mg
timeFrame: up to 8 hours
measure: Time spend in hospital measured as nights after surgery
timeFrame: At discharge (mean 2-3 nights)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 8 hours
measure: Postoperative pain scores on the Visual Analog Scale (at rest)
timeFrame: up to 8 hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidover
city: Hørsholm
country: Denmark
facility: Hørsholm Hospital
Study officials:
References:
Clinical trial NCT02766855: Efficacy of Topical Cysteamine in Nephropathic Cyctinosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephropathic Cyctinosis
Corneal Cystine Crystals
Keywords: cysteamine
nephropathic cystinosis
cystine crystals
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.

Detailed description: A total of 26 patients with nephropathic cystinosis were included in this prospective study. Patients were evaluated for improvement of corneal cysteine deposits crystals and photophobia following treatment with topical 0.55% cysteamine eye drops.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed diagnosis of nephropathic cystinosis
* leucocyte cystine concentration level of more than 2.0 nmol half-cystine/ mg protein
* clinical evidence of tissue deposition of cystine and tissue damage due to cystinosis

Exclusion Criteria:

* Allergy to cysteamine

Primary outcomes:
measure: Number of participants with improvement of photophobia, corneal cystine crystals and visual acuity following treatment with topical cysteamine 0.55% eye drops in patients with nephropathic cystinosis.
timeFrame: Photophobia, slit lamp assessment of corneal cystine crystals and visual acuity are recorded pretreatment, on each monthly visit up to 48 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Al-Hemidan A, Shoughy SS, Kozak I, Tabbara KF. Efficacy of topical cysteamine in nephropathic cystinosis. Br J Ophthalmol. 2017 Sep;101(9):1234-1237. doi: 10.1136/bjophthalmol-2016-309278. Epub 2017 Jan 5.
Clinical trial NCT00230555: The MOM Program at the Children's Hospital of Philadelphia
Official title: The MOM Program at the Children's Hospital of Philadelphia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Child Development
Keywords: child, preschool
environment
intelligence
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2005-10-03
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the MOM Program is to promote child development by helping families become more competent in accessing and using available resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The hypothsis is that children receiving the intervention will participate in more of the public services and primary healthcare activities which have been shown to be effective in improving their development.

Detailed description: The MOM Program is a 3 year randomized controlled trial of mothers and newborns. At enrollment subjects are given a questionnaire to assess self efficacy and a non-verbal test of intelligence. Program personnel are blind to the results of this testing. Test results will be used in data analysis at the end of the study to compare outcomes of the intervention and control groups and to assess how mothers with impaired cognitive ability have benefited from participation in the study.The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. At 33 months of age all children receive a developmental assessment.

Eligibility criteria: Inclusion Criteria: mothers from West and South Philadelphia who have given birth on the post-partum unit at the Hospital of the University of Pennsylvania during the six month enrollment period from July, 2001 to Jan, 2002..

-

Exclusion Criteria: women or infants who are critically ill, those involving multiple births (ie twins), and women who are solely non-English speaking.

-

Primary outcomes:
measure: child intelligence, 33 months of age
Secondary outcomes:
measure: At child age 33 months: maternal intelligence
measure: At child age 33 months:caregiver depression
measure: At child age 33 months: childhood immunization completion At child age 33 months: Early Intervention usage
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Donald F Schwarz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06955455: Ultrasound-Guided Corticosteroid and Bupivacaine for Facial Nerve Function and Thickness in Bell's Palsy
Official title: Effectiveness of Ultrasound-Guided Corticosteroid and Bupivacaine Injections on Facial Nerve Function and Thickness in Acute Bell's Palsy: A Preliminary Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell&#39;s Palsy
Lead sponsor: Tishreen University Hospital
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, single-arm clinical study aims to evaluate the effects of a one-time, ultrasound-guided injection of corticosteroid (triamcinolone) combined with local anesthetic (bupivacaine) into the facial nerve in patients with acute Bell's palsy. The injection is administered approximately 1.5-2 cm after the nerve exits the stylomastoid foramen, with precise targeting using ultrasound imaging.

A total of 40 adult participants diagnosed within 72 hours of symptom onset will be enrolled. The primary outcome is improvement in facial nerve function, assessed using the House-Brackmann Facial Nerve Grading System at day 7, day 15, and 3 months post-injection. Secondary outcomes include changes in facial nerve thickness measured by ultrasound before and one week after the procedure.

This is the first clinical trial to directly evaluate targeted facial nerve injection as a potential treatment approach in Bell's palsy.


Eligibility criteria: Inclusion Criteria

Age between 18 and 70 years

Diagnosis of acute Bell's palsy within the past 72 hours

House-Brackmann Grade III or higher

Willing and able to give informed consent

Able to attend all follow-up assessments

Exclusion Criteria:

History of chronic facial nerve disorders

Known allergies to corticosteroids or local anesthetics

Coagulopathy or current use of anticoagulant therapy

MRI or CT findings indicating alternative causes of facial nerve palsy (e.g., tumor, stroke, MS)

Pregnancy or breastfeeding

Participation in another interventional clinical trial

-

Primary outcomes:
measure: Improvement in facial nerve function using the House-Brackmann grading scale
timeFrame: 7 day, 15 days, and 3 months post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University Hospital
Study officials:
References:
Clinical trial NCT00092755: An Investigational Drug in Patients With Osteoarthritis (0663-073)
Official title: A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 548
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to assess the safety and tolerability of an investigational drug and to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both men and women.

Detailed description: The duration of treatment is 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis of the hip or knee who use current approved medication (nonsteroidal anti-inflammatory drugs (NSAIDs)) or tylenol to treat the symptoms of their osteoarthritis. Patients taking NSAIDs are required to discontinue using these drugs and their symptoms must become worse.

Exclusion Criteria:

* Patients with certain medical conditions may not be allowed to participate. These conditions will be reviewed with the study physician.

Primary outcomes:
measure: WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status Scale. Efficacy data collected at Weeks 2, 4, 8, and 12.
Secondary outcomes:
measure: Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Womac VA 3.0: Stiffness, Overall Average Score and Overall Subscale Average. Clinical efficacy data collected at Weeks 2, 4, 8, and 12.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Puopolo A, Boice JA, Fidelholtz JL, Littlejohn TW, Miranda P, Berrocal A, Ko A, Cichanowitz N, Reicin AS. A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Dec;15(12):1348-56. doi: 10.1016/j.joca.2007.05.022. Epub 2007 Jul 16.
Clinical trial NCT01925755: Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients
Official title: Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Embolism
Keywords: Non-interventional
Rivaroxaban
Prevention in prior stroke or TIA
Russian Federation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2013-08-20
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients ≥ 18 years old with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before and meet criteria of inclusion and exclusion.

Brief summary: This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years old who start treatment with rivaroxaban
* Non-valvular Atrial Fibrillation is documented in patients' file
* Prior TIA/Stroke history
* TIA - more than 72 hours after documented TIA
* more than 2 weeks after non-hemorrhagic stroke
* Written informed consent

Exclusion Criteria:

* Contraindications for use of Xarelto® in accordance with approved product label
* Previous thromboprophylaxis treatment with anticoagulants prior toby reason of stroke / TIA prevention
* Any reasons of medical and non-medical character, which in the opinion of the physician can hamper patient participation in NIS

Primary outcomes:
measure: Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban
timeFrame: up to 6 months
Secondary outcomes:
measure: Descriptive characteristics of patients after prior stroke/TIA in the need of secondary stroke prevention with Xarelto (gender, age, race, alcohol/smoking, BMI and BP abnormalities, CHA2DS2 VASC, HAS BLED, Rankin Score)
timeFrame: up to 6 months
measure: Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice
timeFrame: up to 6 months
measure: Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Many locations
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03021655: A Pilot Randomized Control Trial to Help Youth Smokers to Quit Smoking:
Official title: Effectiveness of Using Adventure-based Training and WhatsApp Group to Relieve Emotion and Pressure so as to Quit Smoking: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Youth
Randomized controlled trial
Adventure-based training
WhatsApp
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a 3-arm randomized controlled trial including: (1) Adventure-based training intervention group, (2) WhatsApp intervention group and (3) Control group.

Detailed description: Depression and stress are obstacles of youth smokers to quit smoking, youth smokers who have positive thinking and less depression exhibited smoking abstinence at last. Adventure-based training could enhance participants' self-efficacy, self-esteem and also improve mental health of children and youth by doing physical activity. On the other hand, previous mobile phone-based studies (e.g. short messaging services or Apps) showed that the mental health of youth had been improved by providing instant response to the subjects when they felt depressed. A paper published recently proved that WhatsApp group could prevent relapse among the quitters. Thus, adventure-based training and social support in WhatsApp group would predict to reduce depression and stress so as to quit smoking in youth.

Eligibility criteria: Inclusion Criteria:

* Hong Kong resident aged 25 or below
* Able to communicate, read and write in Cantonese/ Chinese
* Smoked in the past 30 days
* Mobile can access internet
* Would access internet through mobile or at home

Exclusion Criteria:

* Have difficulty to communicate via telephone
* Ever used/using psychiatric drugs
* Physically disabled
* Having queries irrelevant to tobacco control
* Undergoing other smoking cessation service

Primary outcomes:
measure: Self-reported 7-day point prevalence
timeFrame: 6-month
Secondary outcomes:
measure: Biochemical validated quit rate
timeFrame: 6-month
measure: Change in Depressive symptoms
timeFrame: 6-month
measure: Change in Self-esteem
timeFrame: 6-month
measure: Change in Quality of life
timeFrame: 6-month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ho-cheung Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03107455: MitraClip in Acute Mitral Regurgitation
Official title: European Registry of MitraClip in Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Acute Myocardial Infarction
Keywords: MitraClip
Acute mitral regurgitation
Acute myocardial infarction
Lead sponsor: Fundación Investigación Sanitaria en León
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2017-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing transmural myocardial infarction in the previous 4 weeks and developing secondary mitral regurgitation not responding to medical therapy.

Brief summary: Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 year-old
* Transmural myocardial infarction in the previous 4 weeks (managed under current guideline's recommendations).
* Symptomatic severe mitral regurgitation diagnosed by left ventriculography, transthoracic echo or trans-oesophageal echo. Symptoms may vary form heart failure to cardiogenic shock.
* Symptoms should be stabilized by medical management: iv diuretics, inotropic support, LV assistance devices
* Considered by heart team at high risk for conventional surgery

Exclusion Criteria:

* Anatomy not suitable for MitraClip implantation
* Technical contraindication for access to left atrium
* Patient candidate for emergent heart transplant
* Uncontrolled infection

Primary outcomes:
measure: Composite primary end point
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Leon
name: Rodrigo Estevez-Loureiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ferraroto Hospital Catania
name: Carmelo Grasso, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Jan Van der Heijden, PhD
role: PRINCIPAL_INVESTIGATOR
References: