louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01124565: Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Official title: A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Keywords: Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Detailed description: Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Eligibility criteria: Inclusion Criteria:

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study
* Previous treatment with botulinum toxin (any serotype)

Primary outcomes:
measure: Assessment of treatment-emergent adverse events based on safety assessments.
timeFrame: 4 weeks and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC
state: Alabama
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
Study officials:
affiliation: Skin Specialists, PC
name: Joel Schlessinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02763865: A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor
Official title: A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 10
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 determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).

Hypothesis: Pre-SMA LF r-TMS will result in a \>30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET.

Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 of age
* Meet the diagnostic criteria for essential tremor with visible upper limb tremor
* Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor

Exclusion Criteria:

* History of seizures
* History of chronic pain conditions
* Any metal in their body above their shoulders
* Use of medications that lower seizure threshold including:

  * broad classes of drugs such as tricyclic antidepressants
  * anti-psychotics
  * neuroeptics
  * thyroid medications and stimulants
* Use of any medications that cause tremor, Pregnancy

Primary outcomes:
measure: Mean TRS (Tremor Rating Score)
timeFrame: Baseline (Visit 2) post intervention
measure: Mean TRS (Tremor Rating Score) at 4 Week Followup
timeFrame: 4 week followup(visit 18)
measure: Mean TRS (Tremor Rating Score) at 8 Week Followup
timeFrame: 8 week followup (visit 19)
measure: Mean TRS (Tremor Rating Score) at 12 Week Followup
timeFrame: 12-week followup(visit 20)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06355765: Citicoline & Antioxidants in Glaucoma
Official title: Effect of Oral Citicoline, Vitamins A, B, C and E, and Blackcurrant in Primary Open-Angle Glaucoma With OCT and Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.

Detailed description: AIMS: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.

METHODS: Fifteen patients with POAG (treated group) received one soluble liquid sachet daily for 20 days a month of a complementary dietary supplement containing in fixed combination citicoline, vitamins A, B, C, and E, and blackcurrant for 1 year. Fifteen age-matched subjects affected by POAG were given a placebo and served as a control group. The patients underwent best corrected visual acuity (BCVA), Goldmann applanation tonometry, microperimetry examination, OCT, and OCTA at the beginning of the study and then at 1, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* diagnosis of POAG
* aged between 18 and 75 years
* Patients with controlled intraocular pressure (IOP) below 20 mmHg, who had been on the same topical hypotensive therapy for at least 3 months
* myopia less than 5 diopters (D) were considered eligible for inclusion.

Exclusion Criteria:

* IOP levels exceeding 21 mmHg,
* hyper-sensitivity to citicoline,
* a history of optic neuritis,
* previous glaucoma or retinal surgery,
* prior cataract or refractive surgery,
* macular degeneration or other retinal disorders,
* any systemic diseases that could potentially lead to neurodegeneration (e.g., multiple sclerosis, diabetes)

Primary outcomes:
measure: Evaluation of Ganglionar cells complex (GCC)
timeFrame: From enrollment to the end of treatment at 1 year
Secondary outcomes:
measure: Evaluation of Retinal nerve fiber layer (RNFL)
timeFrame: From enrollment to the end of treatment at 1 year
Other outcomes:
Locations:
city: NAples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Luca D'Andrea, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00748865: Acute Comfort and Blur of Systane Ultra and Systane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry Eye
Artificial Tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye

Exclusion Criteria:

* Use of contact lens within 7 days preceding enrollment

Primary outcomes:
measure: Drop Comfort
timeFrame: once upon instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Location
state: Texas
Study officials:
References:
Clinical trial NCT06768866: Factors Influencing PAP and Its PM Among Patient Undergoing Elective Surgeries at Tertiary Care Hospital Mardan
Official title: Factors Influencing Postsurgical Acute Pain and Its Pharmacological Management Among Patient Undergoing Elective Surgeries at Tertiary Care Hospital Mardan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgery-Complications
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To determine factors influencing Postsurgical acute pain

Brief summary: Postsurgical acute pain is a critical factor impacting recovery, patient satisfaction, and the risk of complications in surgical patients. Effective pain management is essential for enhancing patient outcomes and reducing the likelihood of chronic pain development.

Detailed description: However, pain perception is influenced by various factors, including demographic characteristics, types, duration and complexity of surgery, and pharmacological approaches. This study aims to identify these contributing factors and assess the effectiveness of different analgesics in managing postsurgical pain in a tertiary care setting.

Eligibility criteria: Inclusion Criteria:

* Patients with ages of 18 years and above.
* ASA Class I,II are scheduled for elective surgeries under general anesthesia at Tertiary care hospital Mardan.

Exclusion Criteria:

* Chronic opioid and NSAID user, tricyclic antidepressants and selective serotonin reuptake inhibitors.
* People with bleeding disorders.
* Postoperative respiratory depression, patient with emergency surgeries or admitted to ICU Postoperative.
* Procedure perform under regional Anesthesia, history of hypersensitivity to analgesic drugs and refusal to participate"

Primary outcomes:
measure: Visual analog scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: Mardan Medical Complex
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT03747666: Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture
Official title: Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandible Fracture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Detailed description: Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

Eligibility criteria: Inclusion Criteria:

* Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
* Fractures amenable to treatment using intra oral approach.

Exclusion Criteria:

* Medically compromised patients who are unfit for the procedure under general anesthesia.
* Patients with comminuted fractures.
* Patients with history of occlusion disturbances or skeletal malocclusion.
* Patients with insufficient dentition to reproduce occlusion.

Primary outcomes:
measure: Biting force
timeFrame: 6 months
Secondary outcomes:
measure: Stability of fractured segments
timeFrame: 6 weeks
measure: Pain intensity
timeFrame: 10 days
measure: Occlusion
timeFrame: 6 months
measure: Infection
timeFrame: 6 months
measure: Hardware failure
timeFrame: 6 months
measure: Paraesthesia
timeFrame: 6 months
measure: Wound dehiscence
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05340166: Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Official title: Comparative Evaluation of the Ultrasound-guided Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 60
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: Knee osteoarthritis is one of the most common causes of pain and loss of function in the elderly population and is a source of socioeconomic costs. Selective denervation of the superior medial, superior lateral and inferior medial genicular nerves, which provide the sensory innervation of the knee joint, is an effective treatment method used to relieve pain and improve functional capacity. Radiofrequency neurolysis of genicular nerves (RFN) is accepted as an effective technique for the treatment of knee pain. However, due to higher equipment costs, longer procedure times, and procedure-related pain, alternative treatments are needed.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Coagulation disorders
* Rheumatoid disorders
* Infections

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Change from baseline to 6 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: selin guven kose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679366: The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
Official title: The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Throat Pain
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-09-06
Enrollment: 57
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 addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult patients may shorten the duration, and reduce the severity of the disease.

Detailed description: Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may shorten the duration, and reduce the severity of the disease.

Study design A prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in patients with AP.

The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv Medical Center. Signed informed consent will be required from all patients before inclusion.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed

Exclusion Criteria:

* Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10 days prior to inclusion

Primary outcomes:
measure: period of disease
timeFrame: 10 days
Secondary outcomes:
measure: analysis
timeFrame: 10 days
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Leonid Livshits, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04873466: The Effects of Enzyme-rich Malt Extract on Chronic Constipation
Official title: The Effects of Enzyme-rich Malt Extract on Symptoms of Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Quality of Life
Methane Production
Keywords: Constipation
Lead sponsor: The Functional Gut Clinic
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort
Primary purpose: TREATMENT

Brief summary: Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.

Detailed description: This pilot study is an open label, pre-post interventional study to evaluate the use of ERME in the treatment of people with chronic constipation.

This study involves eligible participants that have a diagnosis constipation according to the Knowles-Eccersley-Scott Score (KESS). Participants will receive intervention with a food supplement enzyme-rich malt extract (ERME) at a dose of 15ml twice daily with food.

Before intervention commences, participants will complete baseline breath samples and a 7 day stool diary to assess stool frequency and consistency.

Participants will then receive the ERME as instructed and continue to complete a bowel diary. Then at 4 weeks since starting the intervention, participants will provide another breath sample and complete another set of breath samples.

Eligibility criteria: Inclusion Criteria:

* Participant has diagnosis of chronic constipation according to the KESS score.
* Participant can communicate and understand English.
* Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).

Exclusion Criteria:

* Dependant use of opioid-based medications.
* New use of prokinetic therapy during the study.
* Use of antibiotics in the last 4 weeks.
* Use of probiotics in the last 2 weeks.
* Organic gastrointestinal disease, including inflammatory bowel disease (IBD), coeliac disease and diverticulitis.
* Participant has known mechanical obstruction of the GI tract.
* Participant has diabetes.
* Participant has any hepatic disease.
* Participant has any disease of the CNS.
* Participant has had previous abdominal or colorectal surgery including appendectomy, cholecystectomy, and hysterectomy.
* Participant has intake of ERME for 2 weeks before the study.

Primary outcomes:
measure: Change in constipation score
timeFrame: 35 days
Secondary outcomes:
measure: Change in stool frequency
timeFrame: 35 days
measure: Change in breath methane levels
timeFrame: 35 days
measure: Change in bloating
timeFrame: 35 days
measure: Change in abdominal pain
timeFrame: 35 days
measure: Change in flatulence
timeFrame: 35 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Functional Gut Clinic
state: Greater Manchester
Study officials:
References:
Clinical trial NCT05285566: Pain Control for Undergoing Costal Cartilage Harvesting
Official title: A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nasal Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether injecting the U.S. Food and Drug Administration (FDA) approved drug EXPAREL®, a long acting (approximately 96 hours) numbing medication, will reduce pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest.
* Willing and able to understand and provide written informed consent.

Exclusion Criteria:

* Known pregnancy.
* Women who are currently nursing a child.
* History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder.
* Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation.
* Inability to provide informed consent (patients under guardianship).
* Known hypersensitivity to local anesthetics
* History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
* History of complex pulmonary disease; such as uncontrolled asthma, COPD, or interstitial lung disease as determined by history or review of the medical record.

Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate \< 60 mL/min/BSA as determined by history or review of the medical record.

- History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.

Primary outcomes:
measure: Pain Scores
timeFrame: 7-10 days following the last administration of study treatment
measure: Change in oral pain medication
timeFrame: 7-10 days following the last administration of study treatment
Secondary outcomes:
measure: Adverse Reactions
timeFrame: 7-10 days following the last administration of study treatment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael D Olson, MD
role: PRINCIPAL_INVESTIGATOR
References: