louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01064882: Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 104
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence


Eligibility criteria: Inclusion Criteria:

* Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
* Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

* Any eye disease or abnormality
* Any permanent eyeliner or eyelash implants of any kind
* Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
* Any use of prescription eyelash growth products
* Any use of over the counter eyelash growth products during the 6 months prior to baseline
* Any use of treatments that may affect hair growth during the 6 months prior to baseline

Primary outcomes:
measure: Change From Baseline in Eyelash Length at Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change From Baseline in Upper Eyelash Thickness at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
timeFrame: Month 3
measure: Change From Baseline in Overall Eyelash Satisfaction at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
timeFrame: Baseline, Month 3
measure: Treatment Satisfaction Questionnaire Score at Month 3
timeFrame: Month 3
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06799182: Periodontal Disease and Colorectal Cancer
Official title: The Influence of Periodontal Disease and Periodontal Treatment on Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Colorectal Carcinoma
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Institute of Oncology Ljubljana
name: Institute of microbiology and immunology, Slovenia
First posted: 2025-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this interventional study is to determine the impact of periodontal disease and periodontal treatment on patients with colorectal cancer.

The main questions were:

1. Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment?
2. Can the investigators isolate periodontal pathogenic bacteria Fusobacterium nucleatum and Porphyromonas gingivalis from the mucosa of cancerous colon tissue using the method of quantitative culture?

The investigators will compare the levels of C-reactive protein in the blood of patients undergoing treatment for colorectal cancer who have received periodontal treatment with patients who have not received periodontal treatment. CRP levels will be measured during the first examination with the oncological surgeon, on the first and second day after the surgical procedure, and during the first follow-up with the oncological surgeon.

Additionally, the investigators collected samples of cancerous colon mucosa from 10 participants for the attempt to isolate F. nucleatum and P. gingivalis using the quantitative culture method.


Eligibility criteria: Inclusion Criteria:

* colorectal cancer, scheduled for surgical treatment
* consent to participate

Additional inclusion Criteria fot the control group:

* fiilled questionnaire
* Recorded CRP results at the first examination, after surgery, and at the first follow-up examination.

Exclusion Criteria:

* under 18 years old
* periodontal treatment in the past 12 months
* antibiotic therapy in the last 3 months
* edentulism
* advanced stage cancer, scheduled for palliative care
* chemotherapy or radiotherapy prior to surgical procedure

Primary outcomes:
measure: CRP levels
timeFrame: From the enrollment to the date of first documented progression at 16 weeks
measure: The proportion of Fusobacterium nucleatum and Porphyromonas gingivalis
timeFrame: From the first dental exam to the resective colon surgery at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana, Division of stomatology, Center for oral disease and periodontology
state: Slovenija
Study officials:
affiliation: University Medical Cneter Ljubljana, Division of Stomatology, Center of oral disease and periodontology,
name: Rok Schara, associate professor, doctor of dental medicine
role: STUDY_DIRECTOR
References:
Clinical trial NCT01759082: The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)
Official title: The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Port-wine Stains (PWS)
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Subjects presenting at the CHUV with PWS will be screened and their parents asked to join the study by a member of the research team.
* Subjects who meet the inclusion criteria will be approached for informed written consent and enrolled in the study.

Brief summary: Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system.

The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. It has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment.

Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. They are commonly found on the face and neck and may cause serious psychological consequences.

Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very effective in PWS in closing the blood vessels and diminishing therefore the redness of the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.

Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical inspection and digital photography.

By measuring the activity and intensity of the microcirculation present in and under the skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser (PDL) treatment for port-wine stains.


Eligibility criteria: Inclusion Criteria:

* children aged 12 months to 6 years old
* port-wine stains (PWS)
* phototype's skin I, II or III

Exclusion Criteria:

* phototype's skin IV, V or VI
* prior treatment with laser
* contraindication of general anesthesia
* refusal from the parents

Primary outcomes:
measure: Vascularization's percentage of the PWS with Laser Doppler
timeFrame: For each treatment, spaced about 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Paediatrics Surgery
name: Anthony DeBuys Roessingh, Dr MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02176382: Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Official title: Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 76
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.


Eligibility criteria: Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture

Exclusion Criteria:

* no significant previous use of bone health modifying treatments

Primary outcomes:
measure: Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
timeFrame: Baseline and 42 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Benjamin Leder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramchand SK, David NL, Leder BZ, Tsai JN. Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT. J Clin Endocrinol Metab. 2020 Mar 1;105(3):890-7. doi: 10.1210/clinem/dgz163.
citation: Ramchand SK, David NL, Lee H, Bruce M, Bouxsein ML, Leder BZ, Tsai JN. Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: The DATA-HD HR-pQCT Study. J Bone Miner Res. 2021 Jan;36(1):41-51. doi: 10.1002/jbmr.4161. Epub 2020 Sep 19.
citation: Tsai JN, Lee H, David NL, Eastell R, Leder BZ. Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial. Lancet Diabetes Endocrinol. 2019 Oct;7(10):767-775. doi: 10.1016/S2213-8587(19)30255-4. Epub 2019 Aug 22.
Clinical trial NCT05510882: Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
Official title: Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
tempromandibular joint
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 39
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: this study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with obstructive sleep apnea.

Detailed description: The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022. The patients will be divided equally into three therapy groups each compromise 13 patients:

Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.

Eligibility criteria: Inclusion Criteria:

* • All adult patients, diagnosed as having OSA after full night polysomnography.

Exclusion Criteria:

* • Pregnant patients

Primary outcomes:
measure: This study aims to assess signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with OSA.
timeFrame: up to four months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT02386982: Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients
Official title: A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Hua Medicine Limited
Sponsor class: INDUSTRY
First posted: 2015-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.


Eligibility criteria: Inclusion Criteria:

* Male and female,age 18-65 years
* Has type 2 diabetes mellitus
* BMI 20 to 29kg/m2
* Willingness to adhere to the protocol requirement

Exclusion Criteria:

* Patients with type1 diabetes mellitus
* Received any antidiabetic drug within run-in or during screening
* Hepatic diseases
* Kidney diseases
* Clinical abnormal finding in EVG,labs and physical exams
* Women of child-bearing potential

Primary outcomes:
measure: beta cell function
timeFrame: 4 weeks
measure: HbA1
timeFrame: 4 weeks
measure: 24-hour glucose change
timeFrame: 4 weeks
Secondary outcomes:
measure: The study drug concentration in blood samples to be collected after drug administration
timeFrame: 4 weeks
measure: Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: The 1st Betuhune Hospital of Jilin University
Study officials:
References:
Clinical trial NCT02770482: Amyloid Beta-peptide 1-40 and Alzheimer's Disease
Official title: Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: dementia
biomarkers
cerebrospinal fluid
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 204
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.


Eligibility criteria: Inclusion Criteria:

* Patients attending the Memory Clinic of Champagne-Ardennes for memory disorders, and
* Whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study.

Exclusion Criteria:

* Patients who do not have any social security coverage will not be included.

Primary outcomes:
measure: Percentage of diagnostic certitude for AD (diagnosed cases)
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT00992082: Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
Official title: Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Postoperative pain
Local Infiltration Analgesia
Knee arthroplasty
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
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 whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.

Detailed description: Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total knee arthroplasty under spinal anesthesia.
* Aged 40-85 yrs.
* ASA physical status I-III and mobility indicating normal postoperative mobilization.

Exclusion Criteria:

* Known allergy or intolerance to one of the study drugs.
* Serious liver-, heart- or renal decease.
* Rheumatoid arthritis.
* Chronic pain or bleeding disorder.

Primary outcomes:
measure: Morphine consumption
timeFrame: The first 48 postoperative hours
Secondary outcomes:
measure: Pain intensity
timeFrame: 0-3 months
measure: Knee function
timeFrame: 0-3 months
measure: Time to home readiness
timeFrame: 0-2 weeks
measure: Hospital stay
timeFrame: 0-2 weeks
measure: Side effects
timeFrame: 0-3 months
measure: Patient satisfaction
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Dept. of Orthopedic Surgery
Study officials:
References:
Clinical trial NCT03946982: Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain
Official title: Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Management Qualities After Cesarean Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-cesarean Pain Control Quality
Keywords: Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 189
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than conventional lumbar epidural analgesia?

Detailed description: Postoperative pain remains the leading cause of concern in women faced with undergoing a cesarean delivery. Inadequate acute pain management is associated with numerous negative effects, including delayed postpartum recovery, interference with mother-child bonding because postoperative pain limits breastfeeding, and a high risk of postpartum depression and persistent pain.

Epidural analgesia (EA) is being increasingly preferred to systemic opioid because of better analgesic effect. Although EA is widely used for cesarean delivery, the effect of the site of epidural catheter insertion on the quality of postoperative pain management remains inadequately investigated. For example, placement of the epidural catheter in the low thoracic intervertebral spaces may be more suitable for catheter-incision-congruent analgesia during caesarean delivery than in the lumbar intervertebral space; however, epidural catheter insertion is conventionally recommended at the lumbar intervertebral space. Therefore, in this study, we aim to investigate the difference in post-cesarean pain control quality between low thoracic EA and lumbar EA.

Eligibility criteria: Inclusion:

1. age between 20-yr and 50-yr parturients
2. elective cesarean delivery

Exclusion:

1. contraindicated to regional anesthesia, eg. coagulopathy (INR\> 1.5; platelet\< 80000...etc)
2. significant co-morbidities, eg. preeclamspia, heart failure with New York Heart Association (NYHA) Classification\> class 2
3. allergy to opioids or local anesthetics

Primary outcomes:
measure: Proportion of women with a visual analogue scale> 33 mm
timeFrame: postoperative two days
measure: Pain intensity
timeFrame: postoperative two days
Secondary outcomes:
measure: Adverse effects
timeFrame: postoperative two days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu
role: PRINCIPAL_INVESTIGATOR
References: